A Phase 3 interventional study of clindamycin / benzoyl peroxide gel and clindamycin gel in Acne Vulgaris, sponsored by Stiefel, a GSK Company. Completed at 24 sites in 3 countries. Open to participants aged 12 Years to 45 Years. Per ClinicalTrials.gov, last updated 2016-11-23.
Sponsored by Stiefel, a GSK Company (part of GlaxoSmithKline) · Phase 3, Interventional, and Treatment
This is a Randomized, Double-Blind, Controlled Study to evaluate the Safety and Efficacy of a clindamycin / benzoyl peroxide gel in Subjects with Acne Vulgaris
A multicenter, randomized, double-blind, comparator and vehicle-controlled study in subjects with acne vulgaris. Approximately 1320 subjects will be enrolled. Subjects will be randomized to 1 of 4 parallel study groups in a 1:1:1:1 ratio (clindamycin / benzoyl peroxide gel:clindamycin gel:BPO gel:vehicle gel).
790 studies on the registry are indexed under Acne Vulgaris; 93 are open to participants now.
This study's enrollment of 1,315 is above the median of 70 across 672 interventional studies indexed under Acne Vulgaris.
Browse Acne Vulgaris studies →Stiefel, a GSK Company is the lead sponsor of 56 studies on the registry; none are open to participants now.
First submitted before Stiefel became part of GlaxoSmithKline.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
clindamycin / benzoyl peroxide gel
Drug: clindamycin / benzoyl peroxide gel
Clindamycin gel
Drug: clindamycin gel
BPO gel
Drug: BPO gel
vehicle gel
Drug: vehicle gel
Drug pages: Clindamycin · Benzoyl Peroxide
Once a day application to the face
Once a day application to the face
Once a day application to the face
Once a day application to the face
Number of Participants With Improvement of at Least 2 Grades in the Investigator's Static Global Assessment (ISGA) Score From Baseline to Week 12
During each study visit, investigators/assessors evaluated acne severity of the participants' faces using the ISGA scale: 0=clear skin with no lesions (L); 1=almost clear, rare non-inflammatory L; 2=mild, some non-inflammatory L with no more than a few inflammatory L, no nodular L; 3=moderate, many non-inflammatory L, may have some inflammatory L, but no more than 1 small nodular L; 4=severe, many non-inflammatory and inflammatory L, but no more than a few nodular L; 5=very severe, many non-inflammatory and inflammatory L, and more than a few nodular L.
Time frame: Baseline (Day 1) and Week 12
Mean Change From Baseline (BL) to Week 12 in Inflammatory Lesion Counts
During each study visit, trained study personnel at every investigational center assessed the inflammatory (pustules \[small inflamed elevation of the skin that is filled with pus\], papules \[solid elevation of skin with no visible fluid\], nodules \[larger than papules with significant depth\]) lesion counts for each participant. Each type of lesion was counted separately, and counts were taken from the face (including forehead, nose, cheeks, and chin). Missing values were imputed using the last observation carried forward (LOCF) method.
Time frame: Baseline (Day 1) and Week 12
Mean Change From Baseline to Week 12 in Non-inflammatory Lesion Counts
During each study visit, trained study personnel at every investigational center assessed the non-inflammatory (open comedones \[blackheads\] and closed comedones \[whiteheads\]) lesion counts for each participant. Each type of lesion was counted separately, and counts were taken from the face (including forehead, nose, cheeks, and chin).
Time frame: Baseline (Day 1) and Week 12
Mean Change From Baseline to Week 12 in Total Lesion Counts
During each study visit, trained study personnel at every investigational center assessed the inflammatory (pustules, papules, nodules) and non-inflammatory (open and closed comedones) lesion counts for each participant. Each type of lesion was counted separately; the lesion counts were taken from the face (including forehead, nose, cheeks, and chin). Total lesion counts were calculated as the sum of the inflammatory and non-inflammatory lesion counts.
Time frame: Baseline (Day 1) and Week 12
Mean Percent Change From Baseline to Week 12 in Lesion Counts (Total, Inflammatory, and Non-inflammatory)
During each study visit, trained study personnel at every investigational center assessed the inflammatory (pustules, papules, nodules) and non-inflammatory (open and closed comedones) lesion counts for each participant. Each type of lesion was counted separately; the lesion counts were taken from the face (including forehead, nose, cheeks, and chin). Total lesion counts were calculated as the sum of the inflammatory and non-inflammatory lesion counts. Percent change from Baseline to Week 12 was calculated as the value at Week 12 minus the value at Baseline divided by the Baseline value \* 100.
Time frame: Baseline (Day 1) and Week 12
Number of Participants Who Had a Subject Global Assessment (SGA) Score of 0 or 1 at Week 12
During each study visit, participants evaluated their facial acne (excluding the scalp) using the SGA scale: 0=free of acne, with only an occasional blackhead/whitehead; 1=several blackheads/whiteheads and small pimples, no tender deep-seated bumps/cysts; 2=several to many blackheads/whiteheads and small to medium-sized pimples, one deep-seated bump/cyst; 3=many blackheads/whiteheads, many medium- to large-sized pimples, few deep-seated bumps/cysts; 4=presence of blackheads/whiteheads, several to many medium- to large-sized pimples, deep-seated bumps/cysts dominate.
Time frame: Week 12
Number of Participants Who Had an ISGA Score of 0 or 1 at Week 12
During each study visit, investigators/assessors evaluated the acne severity of participants' faces using the ISGA scal: 0=clear skin with no lesions (L); 1=almost clear, rare non-inflammatory L; 2=mild, some non-inflammatory L with no more than a few inflammatory L, no nodular L; 3=moderate, many non-inflammatory L, may have some inflammatory L, but no more than 1 small nodular L; 4=severe, many non-inflammatory and inflammatory L, but no more than a few nodular L; 5=very severe, many non-inflammatory and inflammatory L, and more than a few nodular L.
Time frame: Week 12
Mean Change From Baseline to Week 12 in Systolic and Diastolic Blood Pressure
Systolic and diastolic blood pressure were measured at Baseline and Week 12 (end of study). Mean change from Baseline was calculated as the mean value at Week 12 minus the mean value at Baseline.
Time frame: Baseline (Day 1) and Week 12
Mean Change From Baseline to Week 12 in Temperature
Temperature was measured at Baseline and Week 12 (end of study). Mean change from Baseline was calculated as the mean value at Week 12 minus the mean value at Baseline.
Time frame: Baseline (Day 1) and Week 12
Mean Change From Baseline to Week 12 in Pulse Rate
Pulse rate was measured at Baseline and Week 12 (end of study). Mean change from Baseline was calculated as the mean value at Week 12 minus the mean value at Baseline.
Time frame: Baseline (Day 1) and Week 12
Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Erythema, Dryness, and Peeling
Erythema (Er, redness), dryness (Dr), and peeling (Pn), were evaluated independently by the investigator as: 0 (absent)=no Er, Dr, or Pn; 1 (slight)=faint red/pink coloration (col.), barely perceptible Dr with no flakes or fissure, mild localized Pn; 2 (mild)=light red/pink col., perceptible Dr with no flakes/fissure, mild and diffuse Pn; 3 (moderate)=medium red col., easily noted Dr and flakes but no fissure; 4 (severe)=beet red col., Dr with flakes and fissure, prominent dense Pn. Change from Baseline was calculated as the value at Weeks 2, 4, 8, and 12 minus the the value at Baseline.
Time frame: Baseline; Weeks 2, 4, 8, and 12
Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Itching and Burning/Stinging
Itching and burning/stinging (piercing pain) were evaluated independently by the investigator as: 0 (none)=normal, no discomfort; 1 (slight)=noticeable discomfort that caused intermittent awareness; 2 (moderate)=noticeable discomfort that caused intermittent awareness and interfered occasionally with normal daily activities; 3 (strong)=definite continuous discomfort that interfered with normal daily activities. Change from Baseline was calculated as the value at Weeks 2, 4, 8, and 12 minus the value at Baseline.
Time frame: Baseline; Weeks 2, 4, 8, and 12
Mean Duration of Study Product Use
Mean duration of study product use was calculated as the average total duration inclusive of missed applications of the study product.
Time frame: Baseline (Day 1) through Week 12
Number of Participants Reporting the Indicated Treatment-emergent Adverse Events (AEs) Resulting in Study Product Discontinuation
An AE included, but was not limited to, any clinically significant worsening of a pre-existing condition; an event occurring from overdose (i.e., a dose higher than that indicated in the protocol) of the study product, whether accidental or intentional; an event occurring from abuse (e.g., use for nonstudy reasons) of the study product; or an event that was associated with the discontinuation of the use of the study product.
Time frame: Baseline (Day 1) through Week 12
| Milestone | Duac Low-dose (LD) Gel | Clindamycin Gel | BPO Gel | Vehicle Gel |
|---|---|---|---|---|
| Started | 327 | 328 | 328 | 332 |
| Completed | 300 | 295 | 296 | 293 |
| Not completed | 27 | 33 | 32 | 39 |
| Withdrew: Withdrawal by subject | 16 | 14 | 15 | 26 |
| Withdrew: Lost to follow-up | 8 | 12 | 11 | 8 |
| Withdrew: Adverse event | 1 | 0 | 2 | 2 |
| Withdrew: Protocol violation | 1 | 2 | 0 | 1 |
| Withdrew: Other: lack of efficacy/lost medication | 1 | 5 | 4 | 2 |
During each study visit, investigators/assessors evaluated acne severity of the participants' faces using the ISGA scale: 0=clear skin with no lesions (L); 1=almost clear, rare non-inflammatory L; 2=mild, some non-inflammatory L with no more than a few inflammatory L, no nodular L; 3=moderate, many non-inflammatory L, may have some inflammatory L, but no more than 1 small nodular L; 4=severe, many non-inflammatory and inflammatory L, but no more than a few nodular L; 5=very severe, many non-inflammatory and inflammatory L, and more than a few nodular L.
| participants | Duac Low-dose (LD) Gel | Clindamycin Gel | BPO Gel | Vehicle Gel |
|---|---|---|---|---|
| Number of Participants With Improvement of at Least 2 Grades in the Investigator's Static Global Assessment (ISGA) Score From Baseline to Week 12 | 129 | 82 | 100 | 59 |
During each study visit, trained study personnel at every investigational center assessed the inflammatory (pustules \[small inflamed elevation of the skin that is filled with pus\], papules \[solid elevation of skin with no visible fluid\], nodules \[larger than papules with significant depth\]) lesion counts for each participant. Each type of lesion was counted separately, and counts were taken from the face (including forehead, nose, cheeks, and chin). Missing values were imputed using the last observation carried forward (LOCF) method.
| lesion counts | Duac Low-dose (LD) Gel | Clindamycin Gel | BPO Gel | Vehicle Gel |
|---|---|---|---|---|
| Mean Change From Baseline (BL) to Week 12 in Inflammatory Lesion Counts | -18.2 ± 10.4 | -15.6 ± 11.6 | -16.8 ± 11.5 | -13.1 ± 12.1 |
During each study visit, trained study personnel at every investigational center assessed the non-inflammatory (open comedones \[blackheads\] and closed comedones \[whiteheads\]) lesion counts for each participant. Each type of lesion was counted separately, and counts were taken from the face (including forehead, nose, cheeks, and chin).
| lesion counts | Duac Low-dose (LD) Gel | Clindamycin Gel | BPO Gel | Vehicle Gel |
|---|---|---|---|---|
| Mean Change From Baseline to Week 12 in Non-inflammatory Lesion Counts | -24.8 ± 20.1 | -19.8 ± 19.8 | -22.2 ± 17.6 | -14.8 ± 21.6 |
During each study visit, trained study personnel at every investigational center assessed the inflammatory (pustules, papules, nodules) and non-inflammatory (open and closed comedones) lesion counts for each participant. Each type of lesion was counted separately; the lesion counts were taken from the face (including forehead, nose, cheeks, and chin). Total lesion counts were calculated as the sum of the inflammatory and non-inflammatory lesion counts.
| lesion counts | Duac Low-dose (LD) Gel | Clindamycin Gel | BPO Gel | Vehicle Gel |
|---|---|---|---|---|
| Mean Change From Baseline to Week 12 in Total Lesion Counts | -43.0 ± 27.1 | -35.5 ± 27.1 | -39.0 ± 25.0 | -27.8 ± 29.8 |
During each study visit, trained study personnel at every investigational center assessed the inflammatory (pustules, papules, nodules) and non-inflammatory (open and closed comedones) lesion counts for each participant. Each type of lesion was counted separately; the lesion counts were taken from the face (including forehead, nose, cheeks, and chin). Total lesion counts were calculated as the sum of the inflammatory and non-inflammatory lesion counts. Percent change from Baseline to Week 12 was calculated as the value at Week 12 minus the value at Baseline divided by the Baseline value \* 100.
| Percent change in lesion counts | Duac Low-dose (LD) Gel | Clindamycin Gel | BPO Gel | Vehicle Gel |
|---|---|---|---|---|
| Inflammatory Lesions | -68.9 ± 29.6 | -58.1 ± 35.8 | -61.8 ± 31.5 | -48.8 ± 37.1 |
| Non-inflammatory Lesions | -53.9 ± 32.2 | -43.3 ± 39.6 | -50.8 ± 33.5 | -34.0 ± 47.2 |
| Total Lesions | -59.8 ± 28.0 | -49.2 ± 33.8 | -55.5 ± 28.8 | -40.4 ± 37.5 |
During each study visit, participants evaluated their facial acne (excluding the scalp) using the SGA scale: 0=free of acne, with only an occasional blackhead/whitehead; 1=several blackheads/whiteheads and small pimples, no tender deep-seated bumps/cysts; 2=several to many blackheads/whiteheads and small to medium-sized pimples, one deep-seated bump/cyst; 3=many blackheads/whiteheads, many medium- to large-sized pimples, few deep-seated bumps/cysts; 4=presence of blackheads/whiteheads, several to many medium- to large-sized pimples, deep-seated bumps/cysts dominate.
| participants | Duac Low-dose (LD) Gel | Clindamycin Gel | BPO Gel | Vehicle Gel |
|---|---|---|---|---|
| Number of Participants Who Had a Subject Global Assessment (SGA) Score of 0 or 1 at Week 12 | 209 | 171 | 189 | 154 |
During each study visit, investigators/assessors evaluated the acne severity of participants' faces using the ISGA scal: 0=clear skin with no lesions (L); 1=almost clear, rare non-inflammatory L; 2=mild, some non-inflammatory L with no more than a few inflammatory L, no nodular L; 3=moderate, many non-inflammatory L, may have some inflammatory L, but no more than 1 small nodular L; 4=severe, many non-inflammatory and inflammatory L, but no more than a few nodular L; 5=very severe, many non-inflammatory and inflammatory L, and more than a few nodular L.
| participants | Duac Low-dose (LD) Gel | Clindamycin Gel | BPO Gel | Vehicle Gel |
|---|---|---|---|---|
| Number of Participants Who Had an ISGA Score of 0 or 1 at Week 12 | 148 | 91 | 116 | 81 |
Systolic and diastolic blood pressure were measured at Baseline and Week 12 (end of study). Mean change from Baseline was calculated as the mean value at Week 12 minus the mean value at Baseline.
| Millimeters of mercury (mmHg) | Duac Low-dose (LD) Gel | Clindamycin Gel | BPO Gel | Vehicle Gel |
|---|---|---|---|---|
| Systolic blood pressure | 0 ± 10 | 0 ± 11 | 0 ± 12 | 0 ± 10 |
| Diastolic blood pressure | 0 ± 8 | 1 ± 9 | 0 ± 8 | 0 ± 8 |
Temperature was measured at Baseline and Week 12 (end of study). Mean change from Baseline was calculated as the mean value at Week 12 minus the mean value at Baseline.
| Degrees centigrade | Duac Low-dose (LD) Gel | Clindamycin Gel | BPO Gel | Vehicle Gel |
|---|---|---|---|---|
| Mean Change From Baseline to Week 12 in Temperature | -0.1 ± 0.4 | 0.0 ± 0.4 | 0.0 ± 0.4 | 0.0 ± 0.4 |
Pulse rate was measured at Baseline and Week 12 (end of study). Mean change from Baseline was calculated as the mean value at Week 12 minus the mean value at Baseline.
| Beats per minute (bpm) | Duac Low-dose (LD) Gel | Clindamycin Gel | BPO Gel | Vehicle Gel |
|---|---|---|---|---|
| Mean Change From Baseline to Week 12 in Pulse Rate | 1 ± 10 | 2 ± 11 | 2 ± 9 | 2 ± 11 |
Erythema (Er, redness), dryness (Dr), and peeling (Pn), were evaluated independently by the investigator as: 0 (absent)=no Er, Dr, or Pn; 1 (slight)=faint red/pink coloration (col.), barely perceptible Dr with no flakes or fissure, mild localized Pn; 2 (mild)=light red/pink col., perceptible Dr with no flakes/fissure, mild and diffuse Pn; 3 (moderate)=medium red col., easily noted Dr and flakes but no fissure; 4 (severe)=beet red col., Dr with flakes and fissure, prominent dense Pn. Change from Baseline was calculated as the value at Weeks 2, 4, 8, and 12 minus the the value at Baseline.
| scores on a scale | Duac Low-dose (LD) Gel | Clindamycin Gel | BPO Gel | Vehicle Gel |
|---|---|---|---|---|
| Erythema, Week 2, n=298, 302, 306, 306 | -0.05 ± 0.63 | -0.01 ± 0.58 | -0.07 ± 0.56 | -0.02 ± 0.61 |
| Erythema, Week 4, n=298, 300, 299, 306 | -0.07 ± 0.66 | -0.07 ± 0.64 | -0.08 ± 0.67 | -0.06 ± 0.64 |
| Erythema, Week 8, n=297, 296, 294, 293 | -0.12 ± 0.71 | -0.08 ± 0.67 | -0.15 ± 0.68 | -0.08 ± 0.73 |
| Erythema, Week 12, n=297, 296, 296, 294 | -0.17 ± 0.66 | -0.18 ± 0.63 | -0.17 ± 0.67 | -0.13 ± 0.69 |
| Dryness, Week 2, n=298, 302, 306, 306 | 0.07 ± 0.54 | 0.03 ± 0.48 | 0.09 ± 0.61 | 0.04 ± 0.50 |
| Dryness, Week 4, n=298, 300, 299, 306 | 0.05 ± 0.58 | -0.02 ± 0.51 | 0.08 ± 0.55 | 0.00 ± 0.52 |
| Dryness, Week 8, n=297, 296, 294, 293 | 0.00 ± 0.53 | -0.02 ± 0.58 | 0.05 ± 0.57 | 0.02 ± 0.56 |
| Dryness, Week 12, n=297, 296, 296, 294 | -0.07 ± 0.62 | -0.10 ± 0.53 | -0.01 ± 0.57 | -0.04 ± 0.55 |
| Peeling, Week 2, n=298, 302, 306, 306 | 0.03 ± 0.43 | 0.02 ± 0.36 | 0.08 ± 0.51 | 0.02 ± 0.41 |
| Peeling, Week 4, n=298, 300, 299, 306 | -0.01 ± 0.39 | 0.00 ± 0.36 | 0.01 ± 0.39 | 0.00 ± 0.40 |
| Peeling, Week 8, n=297, 296, 294, 293 | -0.01 ± 0.41 | -0.01 ± 0.42 | -0.01 ± 0.40 | 0.00 ± 0.43 |
| Peeling, Week 12, n=297, 296, 296, 294 | -0.08 ± 0.44 | -0.06 ± 0.40 | -0.02 ± 0.50 | -0.04 ± 0.43 |
Itching and burning/stinging (piercing pain) were evaluated independently by the investigator as: 0 (none)=normal, no discomfort; 1 (slight)=noticeable discomfort that caused intermittent awareness; 2 (moderate)=noticeable discomfort that caused intermittent awareness and interfered occasionally with normal daily activities; 3 (strong)=definite continuous discomfort that interfered with normal daily activities. Change from Baseline was calculated as the value at Weeks 2, 4, 8, and 12 minus the value at Baseline.
| scores on a scale | Duac Low-dose (LD) Gel | Clindamycin Gel | BPO Gel | Vehicle Gel |
|---|---|---|---|---|
| Itching, Week 2, n=297, 301, 305, 305 | -0.11 ± 0.67 | -0.18 ± 0.67 | -0.04 ± 0.64 | -0.06 ± 0.65 |
| Itching, Week 4, n=298, 299, 299, 305 | -0.11 ± 0.67 | -0.18 ± 0.68 | -0.07 ± 0.68 | -0.10 ± 0.61 |
| Itching, Week 8, n=297, 295, 293, 291 | -0.16 ± 0.75 | -0.24 ± 0.69 | -0.08 ± 0.68 | -0.08 ± 0.62 |
| Itching, Week 12, n=297, 295, 294, 293 | -0.21 ± 0.70 | -0.28 ± 0.67 | -0.13 ± 0.72 | -0.13 ± 0.63 |
| Burning/Stinging, Week 2, n=297, 301, 305, 305 | 0.02 ± 0.58 | -0.06 ± 0.48 | -0.02 ± 0.56 | -0.05 ± 0.53 |
| Burning/Stinging, Week 4, n=298, 2991, 299, 305 | -0.06 ± 0.57 | -0.09 ± 0.46 | -0.05 ± 0.55 | -0.02 ± 0.59 |
| Burning/Stinging, Week 8, n=297, 295, 293, 291 | -0.05 ± 0.57 | -0.09 ± 0.46 | -0.05 ± 0.55 | -0.06 ± 0.54 |
| Burning/Stinging, Week 12, n=297, 295, 294, 293 | -0.09 ± 0.58 | -0.13 ± 0.48 | -0.04 ± 0.60 | -0.04 ± 0.49 |
Mean duration of study product use was calculated as the average total duration inclusive of missed applications of the study product.
| days | Duac Low-dose (LD) Gel | Clindamycin Gel | BPO Gel | Vehicle Gel |
|---|---|---|---|---|
| Mean Duration of Study Product Use | 79.5 ± 16.4 | 78.0 ± 17.9 | 78.0 ± 18.4 | 77.8 ± 18.4 |
An AE included, but was not limited to, any clinically significant worsening of a pre-existing condition; an event occurring from overdose (i.e., a dose higher than that indicated in the protocol) of the study product, whether accidental or intentional; an event occurring from abuse (e.g., use for nonstudy reasons) of the study product; or an event that was associated with the discontinuation of the use of the study product.
| participants | Duac Low-dose (LD) Gel | Clindamycin Gel | BPO Gel | Vehicle Gel |
|---|---|---|---|---|
| Application Site Dermatitis | 1 | 0 | 0 | 0 |
| Application Site Hypersensitivity | 0 | 0 | 1 | 0 |
| Application Site Pruritus | 0 | 0 | 1 | 1 |
| Varicella | 0 | 0 | 0 | 1 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Duac Low-dose (LD) Gel | — | 0/327 (0%) | 72/327 (22%) |
| Clindamycin Gel | — | 0/328 (0%) | 83/328 (25.3%) |
| BPO Gel | — | 1/328 (0.3%) | 102/328 (31.1%) |
| Vehicle Gel | — | 0/332 (0%) | 87/332 (26.2%) |
| Event | Duac Low-dose (LD) Gel | Clindamycin Gel | BPO Gel | Vehicle Gel |
|---|---|---|---|---|
| DepressionPsychiatric disorders | 0/327 | 0/328 | 1/328 | 0/332 |
| Event | Duac Low-dose (LD) Gel | Clindamycin Gel | BPO Gel | Vehicle Gel |
|---|---|---|---|---|
| NasopharyngitisInfections and infestations | 27/327 | 23/328 | 32/328 | 19/332 |
| Upper Respiratory Tract InfectionInfections and infestations | 11/327 | 13/328 | 13/328 | 13/332 |
| HeadacheNervous system disorders | 4/327 | 8/328 | 9/328 | 7/332 |
| InfluenzaInfections and infestations | 3/327 | 5/328 | 1/328 | 4/332 |
| Joint SprainInjury, poisoning and procedural complications | 0/327 | 2/328 | 5/328 | 0/332 |
| SunburnInjury, poisoning and procedural complications | 2/327 | 5/328 | 1/328 | 2/332 |
| Pharyngolaryngeal PainRespiratory, thoracic and mediastinal disorders | 3/327 | 0/328 | 2/328 | 2/332 |
| Stomach DiscomfortGastrointestinal disorders | 2/327 | 0/328 | 0/328 | 0/332 |
| Application Site DermatitisGeneral disorders | 2/327 | 0/328 | 0/328 | 0/332 |
| Application Site Photosensitivity ReactionGeneral disorders | 2/327 | 1/328 | 1/328 | 2/332 |
| Age, Continuous(Years) | Duac Low-dose (LD) Gel | Clindamycin Gel | BPO Gel | Vehicle Gel | Total |
|---|---|---|---|---|---|
| Mean | 20.0 ± 7.0 | 20.2 ± 6.9 | 20.6 ± 7.1 | 20.7 ± 7.4 | 20.4 ± 7.1 |
| Sex: Female, Male(Participants) | Duac Low-dose (LD) Gel | Clindamycin Gel | BPO Gel | Vehicle Gel | Total |
|---|---|---|---|---|---|
| Female | 202 | 180 | 203 | 210 | 795 |
| Male | 125 | 148 | 125 | 122 | 520 |
| Race/Ethnicity, Customized(participants) | Duac Low-dose (LD) Gel | Clindamycin Gel | BPO Gel | Vehicle Gel | Total |
|---|---|---|---|---|---|
| White | 259 | 274 | 251 | 258 | 1042 |
| Black | 47 | 37 | 54 | 54 | 192 |
| Asian | 13 | 9 | 17 | 16 | 55 |
| Multiracial | 5 | 7 | 7 | 4 | 23 |
| American Indian or Alaska Native | 3 | 1 | 0 | 0 | 4 |
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.
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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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drugs tested here: Clindamycin · Benzoyl Peroxide