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CompletedNCT00964223Updated Nov 23, 2016Results posted

A Study to Evaluate Tolerability of Two Topical Drug Products in the Treatment of Facial Acne

A Phase 4 interventional study of Clindamycin and benzoyl peroxide gel (Duac® Topical Gel) and benzoyl peroxide and adapalene gel (EPIDUO™ Gel) in Acne Vulgaris, sponsored by Stiefel, a GSK Company. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-11-23.

Sponsored by Stiefel, a GSK Company · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
28
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Multi-center, single-blind, randomized, comparative, split-face study. The duration of the study is 8 weeks. Commencing at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide gel and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.

Read the detailed description

Multi-center, single-blind, randomized, comparative, split-face study. The duration of the study is 8 weeks and consists of a baseline visit and visits at weeks 1, 2, 5 and 8. Commencing at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide gel and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3 subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.

Blinding This is an investigator-blinded study; therefore, subjects and study-center staff will not be blinded to study treatment allocation (ie, left vs. right side application). During the first 2 weeks, the investigator will be unaware of which study product is being used on either side of the face. Subjects and study-center staff will be instructed not to reveal study treatment allocation to the investigator. Subjects will be instructed not to use study product in the presence of the investigator.

02

Conditions studied

  • Acne Vulgaris

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Keywords

  • Acne vulgaris
03

In context

Acne Vulgaris

730 studies on the registry are indexed under Acne Vulgaris; 86 are open to participants now.

This study's enrollment of 28 is below the median of 69 across 628 interventional studies indexed under Acne Vulgaris.

Browse Acne Vulgaris studies →

Lead sponsor

Stiefel, a GSK Company is the lead sponsor of 55 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Male or female subjects at least 18 years of age, in good general health with documented diagnosis of facial acne vulgaris.
  • Sexually active females of childbearing potential participating in the study must agree to use a medically acceptable method of contraception while receiving protocol-assigned product.
  • Subjects willing to follow therapeutic instructions including avoidance of any other topical facial or systemic acne therapy during the conduct of the study.
  • Capable of understanding and willing to provide signed and dated written voluntary informed consent before any protocol specific procedures are performed.

Exclusion criteria

Exclusion Criteria:

  • Female subjects who are pregnant, trying to become pregnant or breastfeeding.
  • Subjects who have any clinically relevant finding at their baseline physical examination or medical history such as severe systemic diseases, diseases of the facial skin, other than acne vulgaris.
  • Facial hair that may obscure the accurate assessment of acne grade.
  • History or presence of regional enteritis or inflammatory bowel disease (e.g., ulcerative colitis, pseudomembranous colitis, chronic diarrhea, or a history of antibiotic-associated colitis) or similar symptoms.
  • Use of topical antibiotics on the face and systemic antibiotics within the past 2 and 4 weeks, respectively.
  • Use of topical corticosteroids on the face or systemic corticosteroids within the past 4 weeks. Use of inhaled, intra-articular or intra-lesional (other than for facial acne lesions) steroids is acceptable.
  • Use of systemic retinoids within the past 6 months.
  • Concurrent use of drugs known to be photosensitizers (e.g., thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides) because of the possibility of increased phototoxicity.
  • Concomitant use of neuromuscular blocking agents. Clindamycin has neuromuscular blocking activities, which may enhance the action of other neuromuscular blocking agents.
  • Use of topical anti-acne medications within the past 2 weeks.
  • Use of any investigational drugs or treatments during the study or within 4 weeks of the baseline visit.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
28 participants (actual)

Study arms

  • Experimental
    Duac gel

    Subjects will apply Duac gel once a day to one-half of their face and and apply Epiduo gel on the other side of their face once daily for the first 2 weeks.

    Drug: Clindamycin and benzoyl peroxide gel (Duac® Topical Gel)

  • Active comparator
    Epiduo gel

    Subjects will apply Duac gel once a day to one-half of their face and and apply Epiduo gel on the other side of their face once daily for the first 2 weeks.

    Drug: benzoyl peroxide and adapalene gel (EPIDUO™ Gel)

Interventions

  • DrugClindamycin and benzoyl peroxide gel (Duac® Topical Gel)

    Subjects will apply Duac(clindamycin and benzoyl peroxide) gel to one-half of their face and and apply Epiduo (benzoyl peroxide/adapalene) gel on the other side of their face once a day for the first 2 weeks. Starting at week 2, subjects will apply Duac (benzoyl peroxide/clindamycin gel) to the entire face for an additional 6 weeks.

    Also known as: Duac® Topical Gel

  • Drugbenzoyl peroxide and adapalene gel (EPIDUO™ Gel)

    Subjects will apply Duac(clindamycin and benzoyl peroxide) gel to one-half of their face and and apply Epiduo (benzoyl peroxide/adapalene) gel on the other side of their face once a day for the first 2 weeks. Starting at week 2, subjects will apply Duac (benzoyl peroxide/clindamycin gel) to the entire face for an additional 6 weeks.

    Also known as: EPIDUO™ Gel

06

What researchers measure

Primary outcomes

  1. Skin Dryness Score

    Investigator assessment of tolerability (skin dryness) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; 3, Intense.

    Time frame: Week 1, Week 2

  2. Skin Peeling Score

    Investigator assessment of tolerability (skin peeling) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; Intense, 3.

    Time frame: Week 1, Week 2

  3. Irritant/Allergic Contact Dermatitis Score

    Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis) on the face. Erythema,peeling, and dryness were graded using the following scale: 0 None 1. Slight 2. Moderate 3. Intense

    Time frame: Week 1, Week 2

  4. Erythema (Redness) Score

    Investigator assessment of tolerability (irritant/allergic contact dermatitis) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; 3, Intense.

    Time frame: Week 1, Week 2

Secondary outcomes

  1. Erythema (Redness) Score

    Investigator assessment of tolerability (erythema) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; 3, Intense.

    Time frame: Week 5, Week 8

  2. Skin Dryness Score

    Investigator assessment of tolerability (skin dryness) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; 3, Intense.

    Time frame: Week 5, Week 8

  3. Skin Peeling Score

    Investigator assessment of tolerability (skin peeling) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; 3, Intense.

    Time frame: Week 5, Week 8

  4. Irritant/Allergic Contact Dermatitis Score

    Investigator assessment of tolerability (contact dermatitis) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; 3, Intense.

    Time frame: Week 5, Week 8

  5. Investigator Static Global Assessment Score

    ISGA is evaluated using the following scale: 0, clear, clear skin with no lesions; 1, almost clear, rare non-inflammatory lesions; 2, mild, some non-inflammatory lesions with no more than a few inflammatory lesions but no nodular lesions; 3, moderate, up to many non-inflammatory lesions and may have some inflammatory lesions, but no more than 1 small nodular lesion; 4, severe, up to many non-inflammatory and inflammatory lesions, but no more than a few nodular lesions; 5, very severe, many non-inflammatory and inflammatory lesions and more than a few nodular lesions. May have cystic lesions.

    Time frame: Week 5, Week 8

  6. Inflammatory Acne Lesion Counts

    Total number of inflammatory acne lesions (pustules, papules) at each timepoint.

    Time frame: Week 5, Week 8

  7. Non-Inflammatory Acne Lesion Counts

    Total number of non-inflammatory acne lesions (whiteheads and blackheads) at each timepoint.

    Time frame: Week 5, Week 8

  8. Total Acne Lesion Counts

    Total acne lesion counts - includes both inflammatory acne lesions (pustules, papules), noninflammatory lesions (whiteheads and blackheads),

    Time frame: Week 5, Week 8

  9. Skindex-29 Quality of Life Questionnaire - Symptomatic Domain

    Skindex-29 Quality of Life (QoL) Questionnaire used in dermatological disease consisting of 29 questions covering: burden of symptoms, functioning and emotional domains, with a five-point scale from: "never" to "all the time", higher scores for each domain indicate worse effects on QoL. Scores range from 0 to 100. Higher scores indicate worse QoL for that domain.

    Time frame: Baseline, and Week 8

  10. Skindex-29 Quality of Life Questionnaire - Emotional Domain

    Skindex-29 Quality of Life (QoL)Questionnaire used in dermatological disease consisting of 29 questions covering: burden of symptoms, functioning and emotional domains, with a five-point scale from: "never" to "all the time", higher scores for each domain indicate worse effects on QoL. Scores range from 0 to 100. Higher scores indicate worse QoL for that domain.

    Time frame: Baseline, and Week 8

  11. Skindex-29 Quality of Life Questionnaire - Functional Domain

    Skindex-29 Quality of Life (QoL)Questionnaire used in dermatological disease consisting of 29 questions covering: burden of symptoms, functioning and emotional domains, with a five-point scale from: "never" to "all the time", higher scores for each domain indicate worse effects on QoL. Scores range from 0 to 100. Higher scores indicate worse QoL for that domain.

    Time frame: Baseline, and Week 8

  12. Skindex-29 Quality of Life Questionnaire - Global Score

    Skindex-29 Quality of Life (QoL)Questionnaire used in dermatological disease consisting of 29 questions covering: burden of symptoms, functioning and emotional domains, with a five-point scale from: "never" to "all the time", higher scores for each domain indicate worse effects on QoL. The Global Score ranges from 0 to 100. Higher scores indicate worse QoL for that domain.

    Time frame: Baseline, and Week 8

  13. Product Acceptability and Preference Questionnaire - Severity of Redness

    Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe.

    Time frame: Week 1, Week 2

  14. Product Acceptability and Preference Questionnaire - Severity of Redness

    Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe.

    Time frame: Week 8

  15. Product Acceptability and Preference Questionnaire - Severity of Dryness

    Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe.

    Time frame: Week 1, Week 2

  16. Product Acceptability and Preference Questionnaire - Severity of Dryness

    Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe.

    Time frame: Week 8

  17. Product Acceptability and Preference Questionnaire - Severity of Burning

    Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe.

    Time frame: Week 1, Week 2

  18. Product Acceptability and Preference Questionnaire - Severity of Burning

    Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe.

    Time frame: Week 8

  19. Product Acceptability and Preference Questionnaire - Severity of Itching

    Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe.

    Time frame: Week 1, Week 2

  20. Product Acceptability and Preference Questionnaire - Severity of Itching

    Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe.

    Time frame: Week 8

  21. Product Acceptability and Preference Questionnaire - Severity of Scaling

    Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe.

    Time frame: Week 1, Week 2

  22. Product Acceptability and Preference Questionnaire - Severity of Scaling

    Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe.

    Time frame: Week 8

  23. Product Acceptability and Preference Questionnaire - Ease of Application of Product

    Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 1, very easy; 2, easy; 3, neutral; 4, difficult; 5, very difficult.

    Time frame: Week 1, Week 2

  24. Product Acceptability and Preference Questionnaire - Ease of Application of Product

    Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 1, very easy; 2, easy; 3, neutral; 4, difficult; 5, very difficult.

    Time frame: Week 8

  25. Product Acceptability and Preference Questionnaire - Comfort of Skin

    Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 1, very comfortable; 2, comfortable; 3, somewhat comfortable; 4, somewhat uncomfortable; 5, uncomfortable.

    Time frame: Week 1, Week 2

  26. Product Acceptability and Preference Questionnaire - Comfort of Skin

    Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 1, very comfortable; 2, comfortable; 3, somewhat comfortable; 4, somewhat uncomfortable; 5, uncomfortable.

    Time frame: Week 8

  27. Product Acceptability and Preference Questionnaire - Which Study Product is Subject More Satisfied With?

    Product Acceptability and Preference Questionnaire was completed by the subject at week 1 and week 2 asking which study product they were more satisfied with: Duac or Epiduo.

    Time frame: Week 1, Week 2

  28. Product Acceptability and Preference Questionnaire - Comparison of Study Products to Products Used in the Past

    Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 1, more satisfied; 2, somewhat more satisfied; 3, neither satisfied or dissatisfied; 4, more satisfied; 5, more dissatisfied.

    Time frame: Week 8

  29. Product Acceptability and Preference Questionnaire - Decrease of Acne Breakouts by Study Products

    Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 1, highly favorable; 2, favorable; 3, neutral; 4, unfavorable; 5, highly unfavorable.

    Time frame: Week 1, Week 2

  30. Product Acceptability and Preference Questionnaire - Decrease of Acne Breakouts by Study Products

    Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 1, highly favorable; 2, favorable; 3, neutral; 4, unfavorable; 5, highly unfavorable.

    Time frame: Week 8

  31. Product Acceptability and Preference Questionnaire - Compliance

    Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, non-compliant (\< 50% of the week); 1, mostly compliant (50-79%); 2, very compliant (80-100%).

    Time frame: Week 1, Week 2

  32. Product Acceptability and Preference Questionnaire - Compliance

    Subject response to question regarding use of the product every day or not at week 8 time point answering Yes or No

    Time frame: Week 8

  33. Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin

    Subject response to question: did you feel that your skin was hydrated and moisturized while you on your study product? (Yes or No).

    Time frame: Week 1, Week 2

  34. Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin

    Subject response to question: did you feel that your skin was hydrated and moisturized while you on your study product? (Yes or No).

    Time frame: Week 8

  35. Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment

    Subject response to the following question: If you were to choose to continue treatment for your acne, which treatment would you choose? (Yes or No).

    Time frame: Week 1, Week 2

  36. Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment

    Subject response to the following question: If you were to choose to continue treatment for your acne, which treatment would you choose? (Yes or No).

    Time frame: Week 8

  37. Product Acceptability and Preference Questionnaire - Ease of Use With Make-Up

    Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, not applicable; 1, very easy; 2, easy; 3, neutral; 4, difficult.

    Time frame: Week 1, Week 2

  38. Product Acceptability and Preference Questionnaire - Ease of Use With Make-Up

    Measure Description Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, not applicable; 1, very easy; 2, easy; 3, neutral; 4, difficult.

    Time frame: Week 8

  39. Product Acceptability and Preference Questionnaire - Overall Satisfaction of Study Product

    Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 1, very satisfied; 2, satisfied; 3, neutral; 4, unsatisfied; 5, very unsatisfied.

    Time frame: Week 1, Week 2

  40. Product Acceptability and Preference Questionnaire - Overall Satisfaction of Study Product

    Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 1, very satisfied; 2, satisfied; 3, neutral; 4, unsatisfied; 5, very unsatisfied.

    Time frame: Week 8

07

Results

Posted Aug 25, 2011

Participant flow

Clinical research centers

Split Face Treatment (Weeks 1 and 2)
Participant flow — Split Face Treatment (Weeks 1 and 2)
MilestoneAll Study Participants
Started28
Completed28
Not completed0
Full Face Treatment (Weeks 5 and 8)
Participant flow — Full Face Treatment (Weeks 5 and 8)
MilestoneAll Study Participants
Started28
Completed27
Not completed1
Withdrew: Lost to follow-up1

Outcome measures

PrimarySkin Dryness Score

Investigator assessment of tolerability (skin dryness) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; 3, Intense.

Time frame:
Week 1, Week 2
Reported as:
Mean · Units on a scale
Skin Dryness Score
Units on a scaleDuac GelEpiduo Gel
Week 10.15 ± 0.370.46 ± 0.71
Week 20.14 ± 0.360.29 ± 0.53
PrimarySkin Peeling Score

Investigator assessment of tolerability (skin peeling) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; Intense, 3.

Time frame:
Week 1, Week 2
Reported as:
Mean · Units on a scale
Skin Peeling Score
Units on a scaleDuac GelEpiduo Gel
Week 10.15 ± 0.370.54 ± 0.71
Week 20.18 ± 0.390.21 ± 0.50
PrimaryIrritant/Allergic Contact Dermatitis Score

Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis) on the face. Erythema,peeling, and dryness were graded using the following scale: 0 None 1. Slight 2. Moderate 3. Intense

Time frame:
Week 1, Week 2
Reported as:
Mean · Units on a scale
Irritant/Allergic Contact Dermatitis Score
Units on a scaleDuac GelEpiduo Gel
Week 10.00 ± 0.000.15 ± 0.46
Week 20.00 ± 0.000.00 ± 0.00
PrimaryErythema (Redness) Score

Investigator assessment of tolerability (irritant/allergic contact dermatitis) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; 3, Intense.

Time frame:
Week 1, Week 2
Reported as:
Mean · Units on a scale
Erythema (Redness) Score
Units on a scaleDuac GelEpiduo Gel
Week 10.27 ± 0.530.58 ± 0.81
Week 20.18 ± 0.390.36 ± 0.49
SecondaryErythema (Redness) Score

Investigator assessment of tolerability (erythema) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; 3, Intense.

Time frame:
Week 5, Week 8
Reported as:
Mean · Units on a scale
Erythema (Redness) Score
Units on a scaleDuac Gel
Week 50.26 ± 0.53
Week 80.19 ± 0.40
SecondarySkin Dryness Score

Investigator assessment of tolerability (skin dryness) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; 3, Intense.

Time frame:
Week 5, Week 8
Reported as:
Mean · Units on a scale
Skin Dryness Score
Units on a scaleDuac Gel
Week 50.15 ± 0.46
Week 80.00 ± 0.00
SecondarySkin Peeling Score

Investigator assessment of tolerability (skin peeling) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; 3, Intense.

Time frame:
Week 5, Week 8
Reported as:
Mean · Units on a scale
Skin Peeling Score
Units on a scaleDuac Gel
Week 50.00 ± 0.00
Week 80.00 ± 0.00
SecondaryIrritant/Allergic Contact Dermatitis Score

Investigator assessment of tolerability (contact dermatitis) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; 3, Intense.

Time frame:
Week 5, Week 8
Reported as:
Mean · Units on a scale
Irritant/Allergic Contact Dermatitis Score
Units on a scaleDuac Gel
Week 50.04 ± 0.19
Week 80.00 ± 0.00
SecondaryInvestigator Static Global Assessment Score

ISGA is evaluated using the following scale: 0, clear, clear skin with no lesions; 1, almost clear, rare non-inflammatory lesions; 2, mild, some non-inflammatory lesions with no more than a few inflammatory lesions but no nodular lesions; 3, moderate, up to many non-inflammatory lesions and may have some inflammatory lesions, but no more than 1 small nodular lesion; 4, severe, up to many non-inflammatory and inflammatory lesions, but no more than a few nodular lesions; 5, very severe, many non-inflammatory and inflammatory lesions and more than a few nodular lesions. May have cystic lesions.

Time frame:
Week 5, Week 8
Reported as:
Mean · Units on a scale
Investigator Static Global Assessment Score
Units on a scaleDuac Gel
Week 52.63 ± 0.93
Week 82.15 ± 1.03
SecondaryInflammatory Acne Lesion Counts

Total number of inflammatory acne lesions (pustules, papules) at each timepoint.

Time frame:
Week 5, Week 8
Reported as:
Mean · inflammatory acne lesions
Inflammatory Acne Lesion Counts
inflammatory acne lesionsDuac Gel
Week 58.44 ± 7.57
Week 87.00 ± 9.03
SecondaryNon-Inflammatory Acne Lesion Counts

Total number of non-inflammatory acne lesions (whiteheads and blackheads) at each timepoint.

Time frame:
Week 5, Week 8
Reported as:
Mean · non-inflammatory acne lesions
Non-Inflammatory Acne Lesion Counts
non-inflammatory acne lesionsDuac Gel
Week 514.37 ± 11.20
Week 810.81 ± 8.88
SecondaryTotal Acne Lesion Counts

Total acne lesion counts - includes both inflammatory acne lesions (pustules, papules), noninflammatory lesions (whiteheads and blackheads),

Time frame:
Week 5, Week 8
Reported as:
Mean · total acne lesions
Total Acne Lesion Counts
total acne lesionsDuac Gel
Week 522.81 ± 14.87
Week 817.81 ± 14.04
SecondarySkindex-29 Quality of Life Questionnaire - Symptomatic Domain

Skindex-29 Quality of Life (QoL) Questionnaire used in dermatological disease consisting of 29 questions covering: burden of symptoms, functioning and emotional domains, with a five-point scale from: "never" to "all the time", higher scores for each domain indicate worse effects on QoL. Scores range from 0 to 100. Higher scores indicate worse QoL for that domain.

Time frame:
Baseline, and Week 8
Reported as:
Mean · Units on a scale
Skindex-29 Quality of Life Questionnaire - Symptomatic Domain
Units on a scaleDuac Gel
Baseline28.10 ± 17.01
Week 821.72 ± 11.60
SecondarySkindex-29 Quality of Life Questionnaire - Emotional Domain

Skindex-29 Quality of Life (QoL)Questionnaire used in dermatological disease consisting of 29 questions covering: burden of symptoms, functioning and emotional domains, with a five-point scale from: "never" to "all the time", higher scores for each domain indicate worse effects on QoL. Scores range from 0 to 100. Higher scores indicate worse QoL for that domain.

Time frame:
Baseline, and Week 8
Reported as:
Mean · Units on a scale
Skindex-29 Quality of Life Questionnaire - Emotional Domain
Units on a scaleDuac Gel
Baseline44.29 ± 28.03
Week 835.37 ± 26.03
SecondarySkindex-29 Quality of Life Questionnaire - Functional Domain

Skindex-29 Quality of Life (QoL)Questionnaire used in dermatological disease consisting of 29 questions covering: burden of symptoms, functioning and emotional domains, with a five-point scale from: "never" to "all the time", higher scores for each domain indicate worse effects on QoL. Scores range from 0 to 100. Higher scores indicate worse QoL for that domain.

Time frame:
Baseline, and Week 8
Reported as:
Mean · Units on a scale
Skindex-29 Quality of Life Questionnaire - Functional Domain
Units on a scaleDuac Gel
Baseline14.06 ± 13.41
Week 89.10 ± 10.39
SecondarySkindex-29 Quality of Life Questionnaire - Global Score

Skindex-29 Quality of Life (QoL)Questionnaire used in dermatological disease consisting of 29 questions covering: burden of symptoms, functioning and emotional domains, with a five-point scale from: "never" to "all the time", higher scores for each domain indicate worse effects on QoL. The Global Score ranges from 0 to 100. Higher scores indicate worse QoL for that domain.

Time frame:
Baseline, and Week 8
Reported as:
Mean · Units on a scale
Skindex-29 Quality of Life Questionnaire - Global Score
Units on a scaleDuac Gel
Baseline14.06 ± 13.41
Week 89.10 ± 10.39
SecondaryProduct Acceptability and Preference Questionnaire - Severity of Redness

Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe.

Time frame:
Week 1, Week 2
Reported as:
Mean · Units on a scale
Product Acceptability and Preference Questionnaire - Severity of Redness
Units on a scaleDuac GelEpiduo Gel
Week 11.12 ± 1.241.54 ± 1.36
Week 20.78 ± 0.801.00 ± 0.89
SecondaryProduct Acceptability and Preference Questionnaire - Severity of Redness

Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe.

Time frame:
Week 8
Reported as:
Mean · Units on a scale
Product Acceptability and Preference Questionnaire - Severity of Redness
Units on a scaleDuac Gel
Product Acceptability and Preference Questionnaire - Severity of Redness1.00 ± 1.14
SecondaryProduct Acceptability and Preference Questionnaire - Severity of Dryness

Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe.

Time frame:
Week 1, Week 2
Reported as:
Mean · Units on a scale
Product Acceptability and Preference Questionnaire - Severity of Dryness
Units on a scaleDuac GelEpiduo Gel
Week 11.42 ± 1.361.88 ± 1.82
Week 21.31 ± 1.231.58 ± 1.27
SecondaryProduct Acceptability and Preference Questionnaire - Severity of Dryness

Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe.

Time frame:
Week 8
Reported as:
Mean · Units on a scale
Product Acceptability and Preference Questionnaire - Severity of Dryness
Units on a scaleDuac Gel
Product Acceptability and Preference Questionnaire - Severity of Dryness1.22 ± 1.12
SecondaryProduct Acceptability and Preference Questionnaire - Severity of Burning

Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe.

Time frame:
Week 1, Week 2
Reported as:
Mean · Units on a scale
Product Acceptability and Preference Questionnaire - Severity of Burning
Units on a scaleDuac GelEpiduo Gel
Week 11.12 ± 1.241.96 ± 1.61
Week 20.73 ± 0.921.11 ± 1.31
SecondaryProduct Acceptability and Preference Questionnaire - Severity of Burning

Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe.

Time frame:
Week 8
Reported as:
Mean · Units on a scale
Product Acceptability and Preference Questionnaire - Severity of Burning
Units on a scaleDuac Gel
Product Acceptability and Preference Questionnaire - Severity of Burning0.63 ± 0.93
SecondaryProduct Acceptability and Preference Questionnaire - Severity of Itching

Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe.

Time frame:
Week 1, Week 2
Reported as:
Mean · Units on a scale
Product Acceptability and Preference Questionnaire - Severity of Itching
Units on a scaleDuac GelEpiduo Gel
Week 11.19 ± 1.131.42 ± 1.30
Week 20.81 ± 1.021.19 ± 1.27
SecondaryProduct Acceptability and Preference Questionnaire - Severity of Itching

Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe.

Time frame:
Week 8
Reported as:
Mean · Units on a scale
Product Acceptability and Preference Questionnaire - Severity of Itching
Units on a scaleDuac Gel
Product Acceptability and Preference Questionnaire - Severity of Itching0.63 ± 1.01
SecondaryProduct Acceptability and Preference Questionnaire - Severity of Scaling

Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe.

Time frame:
Week 1, Week 2
Reported as:
Mean · Units on a scale
Product Acceptability and Preference Questionnaire - Severity of Scaling
Units on a scaleDuac GelEpiduo Gel
Week 10.77 ± 1.071.15 ± 1.32
Week 20.69 ± 0.931.00 ± 1.17
SecondaryProduct Acceptability and Preference Questionnaire - Severity of Scaling

Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe.

Time frame:
Week 8
Reported as:
Mean · Units on a scale
Product Acceptability and Preference Questionnaire - Severity of Scaling
Units on a scaleDuac Gel
Product Acceptability and Preference Questionnaire - Severity of Scaling0.78 ± 1.28
SecondaryProduct Acceptability and Preference Questionnaire - Ease of Application of Product

Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 1, very easy; 2, easy; 3, neutral; 4, difficult; 5, very difficult.

Time frame:
Week 1, Week 2
Reported as:
Mean · Units on a scale
Product Acceptability and Preference Questionnaire - Ease of Application of Product
Units on a scaleDuac GelEpiduo Gel
Week 11.46 ± 0.581.50 ± 0.71
Week 21.43 ± 0.501.50 ± 0.84
SecondaryProduct Acceptability and Preference Questionnaire - Ease of Application of Product

Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 1, very easy; 2, easy; 3, neutral; 4, difficult; 5, very difficult.

Time frame:
Week 8
Reported as:
Mean · Units on a scale
Product Acceptability and Preference Questionnaire - Ease of Application of Product
Units on a scaleDuac Gel
Product Acceptability and Preference Questionnaire - Ease of Application of Product1.26 ± 0.45
SecondaryProduct Acceptability and Preference Questionnaire - Comfort of Skin

Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 1, very comfortable; 2, comfortable; 3, somewhat comfortable; 4, somewhat uncomfortable; 5, uncomfortable.

Time frame:
Week 1, Week 2
Reported as:
Mean · Units on a scale
Product Acceptability and Preference Questionnaire - Comfort of Skin
Units on a scaleDuac GelEpiduo Gel
Week 12.38 ± 0.942.58 ± 1.24
Week 22.00 ± 0.862.25 ± 1.14
SecondaryProduct Acceptability and Preference Questionnaire - Comfort of Skin

Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 1, very comfortable; 2, comfortable; 3, somewhat comfortable; 4, somewhat uncomfortable; 5, uncomfortable.

Time frame:
Week 8
Reported as:
Mean · Units on a scale
Product Acceptability and Preference Questionnaire - Comfort of Skin
Units on a scaleDuac Gel
Product Acceptability and Preference Questionnaire - Comfort of Skin1.78 ± 0.85
SecondaryProduct Acceptability and Preference Questionnaire - Which Study Product is Subject More Satisfied With?

Product Acceptability and Preference Questionnaire was completed by the subject at week 1 and week 2 asking which study product they were more satisfied with: Duac or Epiduo.

Time frame:
Week 1, Week 2
Reported as:
Number · Participants
Product Acceptability and Preference Questionnaire - Which Study Product is Subject More Satisfied With?
ParticipantsDuac GelEpiduo Gel
Week 1178
Week 21215
SecondaryProduct Acceptability and Preference Questionnaire - Comparison of Study Products to Products Used in the Past

Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 1, more satisfied; 2, somewhat more satisfied; 3, neither satisfied or dissatisfied; 4, more satisfied; 5, more dissatisfied.

Time frame:
Week 8
Reported as:
Mean · Units on a scale
Product Acceptability and Preference Questionnaire - Comparison of Study Products to Products Used in the Past
Units on a scaleDuac Gel
Product Acceptability and Preference Questionnaire - Comparison of Study Products to Products Used in the Past1.93 ± 1.24
SecondaryProduct Acceptability and Preference Questionnaire - Decrease of Acne Breakouts by Study Products

Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 1, highly favorable; 2, favorable; 3, neutral; 4, unfavorable; 5, highly unfavorable.

Time frame:
Week 1, Week 2
Reported as:
Mean · Units on a scale
Product Acceptability and Preference Questionnaire - Decrease of Acne Breakouts by Study Products
Units on a scaleDuac GelEpiduo Gel
Week 12.27 ± 0.782.27 ± 0.72
Week 22.14 ± 0.802.07 ± 0.81
SecondaryProduct Acceptability and Preference Questionnaire - Decrease of Acne Breakouts by Study Products

Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 1, highly favorable; 2, favorable; 3, neutral; 4, unfavorable; 5, highly unfavorable.

Time frame:
Week 8
Reported as:
Mean · Units on a scale
Product Acceptability and Preference Questionnaire - Decrease of Acne Breakouts by Study Products
Units on a scaleDuac Gel
Product Acceptability and Preference Questionnaire - Decrease of Acne Breakouts by Study Products2.07 ± 1.14
SecondaryProduct Acceptability and Preference Questionnaire - Compliance

Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, non-compliant (\< 50% of the week); 1, mostly compliant (50-79%); 2, very compliant (80-100%).

Time frame:
Week 1, Week 2
Reported as:
Mean · Units on a scale
Product Acceptability and Preference Questionnaire - Compliance
Units on a scaleDuac GelEpiduo Gel
Week 11.96 ± 0.201.93 ± 0.20
Week 21.93 ± 0.261.93 ± 0.26
SecondaryProduct Acceptability and Preference Questionnaire - Compliance

Subject response to question regarding use of the product every day or not at week 8 time point answering Yes or No

Time frame:
Week 8
Reported as:
Number · Participants
Product Acceptability and Preference Questionnaire - Compliance
ParticipantsDuac Gel
Yes24
No3
SecondaryProduct Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin

Subject response to question: did you feel that your skin was hydrated and moisturized while you on your study product? (Yes or No).

Time frame:
Week 1, Week 2
Reported as:
Number · Participants
Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin
ParticipantsDuac GelEpiduo Gel
Week 1 - Yes1816
Week 1 - No810
Week 2 - Yes1918
Week 2 - No89
SecondaryProduct Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin

Subject response to question: did you feel that your skin was hydrated and moisturized while you on your study product? (Yes or No).

Time frame:
Week 8
Reported as:
Number · Participants
Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin
ParticipantsDuac Gel
Yes24
No3
SecondaryProduct Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment

Subject response to the following question: If you were to choose to continue treatment for your acne, which treatment would you choose? (Yes or No).

Time frame:
Week 1, Week 2
Reported as:
Number · Participants
Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment
ParticipantsDuac GelEpiduo Gel
Week 1 - Yes1915
Week 1 - No510
Week 2 - Yes1618
Week 2 - No109
SecondaryProduct Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment

Subject response to the following question: If you were to choose to continue treatment for your acne, which treatment would you choose? (Yes or No).

Time frame:
Week 8
Reported as:
Number · Participants
Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment
ParticipantsDuac Gel
Yes20
No7
SecondaryProduct Acceptability and Preference Questionnaire - Ease of Use With Make-Up

Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, not applicable; 1, very easy; 2, easy; 3, neutral; 4, difficult.

Time frame:
Week 1, Week 2
Reported as:
Mean · Units on a scale
Product Acceptability and Preference Questionnaire - Ease of Use With Make-Up
Units on a scaleDuac GelEpiduo Gel
Week 12.31 ± 1.112.38 ± 1.12
Week 21.59 ± 0.871.59 ± 0.87
SecondaryProduct Acceptability and Preference Questionnaire - Ease of Use With Make-Up

Measure Description Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, not applicable; 1, very easy; 2, easy; 3, neutral; 4, difficult.

Time frame:
Week 8
Reported as:
Mean · Units on a scale
Product Acceptability and Preference Questionnaire - Ease of Use With Make-Up
Units on a scaleDuac Gel
Product Acceptability and Preference Questionnaire - Ease of Use With Make-Up1.89 ± 0.96
SecondaryProduct Acceptability and Preference Questionnaire - Overall Satisfaction of Study Product

Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 1, very satisfied; 2, satisfied; 3, neutral; 4, unsatisfied; 5, very unsatisfied.

Time frame:
Week 1, Week 2
Reported as:
Mean · Units on a scale
Product Acceptability and Preference Questionnaire - Overall Satisfaction of Study Product
Units on a scaleDuac GelEpiduo Gel
Week 12.04 ± 0.922.19 ± 1.06
Week 22.21 ± 1.172.32 ± 1.16
SecondaryProduct Acceptability and Preference Questionnaire - Overall Satisfaction of Study Product

Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 1, very satisfied; 2, satisfied; 3, neutral; 4, unsatisfied; 5, very unsatisfied.

Time frame:
Week 8
Reported as:
Mean · Units on a scale
Product Acceptability and Preference Questionnaire - Overall Satisfaction of Study Product
Units on a scaleDuac Gel
Product Acceptability and Preference Questionnaire - Overall Satisfaction of Study Product2.52 ± 1.37

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
All Study Participants—0/28 (0%)0/28 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)All Study Participants
Mean29.6 ± 9.5
Sex: Female, Male
Sex: Female, Male(Participants)All Study Participants
Female24
Male4
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)All Study Participants
Asian2
Black or African American11
White15
Region of Enrollment
Region of Enrollment(participants)All Study Participants
United States28
Investigators Static Global Assessment (ISGA)
Investigators Static Global Assessment (ISGA)(Participants)All Study Participants
Mild2
Moderate20
Severe6
Inflammatory Acne Lesion Count
Inflammatory Acne Lesion Count(Inflammatory Lesion)All Study Participants
Mean21.5 ± 9.3
Non-Inflammatory Acne Lesion Count
Non-Inflammatory Acne Lesion Count(Non-Inflammatory lesion)All Study Participants
Mean33.0 ± 24.7
Total Acne Lesion Count
Total Acne Lesion Count(Acne lesions)All Study Participants
Mean54.5 ± 27.1
08

Study locations

2 sites
  • Aesthetics, Skin Care & Dermasurgery
    Rockville, Maryland 20850, United States
  • Grekin Skin Institute
    Warren, Michigan 48088, United States
09

References and documents

Publications

  • Gonzalez P, Vila R, Cirigliano M. The tolerability profile of clindamycin 1%/benzoyl peroxide 5% gel vs. adapalene 0.1%/benzoyl peroxide 2.5% gel for facial acne: results of a randomized, single-blind, split-face study. J Cosmet Dermatol. 2012 Dec;11(4):251-60. doi: 10.1111/jocd.12013. PubMed 23174047 ↗

Individual participant data

Plan to share: Yes — Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 23, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00964223
Lead sponsor
Stiefel, a GSK Company
Collaborators
GlaxoSmithKline
Responsible party
Sponsor
First posted
Aug 24, 2009
Start date
Jul 2009
Primary completion
Nov 2009
Completion
Nov 2009
Results posted
Aug 25, 2011
Last update
Nov 23, 2016

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.

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Discussion

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