A Phase 4 interventional study of Duac® fixed dose combination gel and ADA 0.1% gel in Acne Vulgaris, sponsored by GlaxoSmithKline. Completed at 15 sites in Japan. Open to participants aged 12 Years to 45 Years. Per ClinicalTrials.gov, last updated 2018-08-20.
Sponsored by GlaxoSmithKline · Phase 4, Interventional, and Treatment
This is a multicentre, randomized, single-blind (investigator is blinded), active (the combination therapy of adapalene [ADA] and clindamycin [CLDM])-controlled and parallel-group study in Japanese subjects with facial acne vulgaris. The purpose of this study is to evaluate the efficacy, safety and tolerability of CLDM 1 percent (%)-benzoyl peroxide 3% (Duac®: trademark owned by GlaxoSmithKline) once daily fixed dose combination gel versus combination therapy of ADA 0.1% gel and CLDM 1% gel in the topical treatment of facial acne vulgaris for 12 weeks. A total of 400 subjects will be screened for enrolment. Subjects will use Duac® fixed dose combination gel with quantity sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) or combination therapy of ADA 0.1% gel with quantity sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and CLDM 1% gel twice daily, once in the morning and once in the evening (at bedtime) for 12 weeks.
Duac® is a registered trademark of Stiefel Laboratories, Inc., a GSK company. Duac® marketed in Japan is CLDM 1%-benzoyl peroxide 3% combination gel.
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Exclusion Criteria:
Subjects will use Duac® fixed dose combination gel (clindamycin phosphate 1.2% and benzoyl peroxide 3%) with quantity sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) for 12 weeks.
Drug: Duac® fixed dose combination gel
Subjects will use combination therapy of ADA 0.1% gel with quantity sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and subjects will also apply CLDM 1% gel twice daily, once in the morning and once in the evening (at bedtime) for 12 weeks. The CLDM 1% gel should apply subsequent to the application of ADA 0.1% gel in the evening. The CLDM 1% gel should be applied to ILs only.
Drug: ADA 0.1% gel · Drug: CLDM 1% gel
Duac® fixed dose combination gel containing clindamycin phosphate 1.2% and benzoyl peroxide 3%.
ADA 0.1% gel containing 0.1% of adapalene.
CLDM 1% gel containing clindamycin phosphate 1.2% (1% as clindamycin).
Percent Change in Total Lesion Counts (TLs) From Baseline to Week 2
The assessor performed a count of IL (papules, pustules, nodular lesions), non-ILs (open and closed comedones) and total lesions (the sum of IL and non-IL) at each study visit. Lesion counts were confined to the face. Change from Baseline was calculated as the value at endpoint minus the value at Baseline. Data for adjusted mean has been reported. Percent change from Baseline is the change from Baseline divided by Baseline value multiplied by 100. The Baseline value was the latest pre-dose assessment value. The non-inflammatory lesions were counted by diagnosis based on palpation of the investigator (or sub-investigator).
Time frame: Baseline (Day 1) and Week 2
Percent Change From Baseline in TLs to Weeks 1, 4, 8 and 12
The assessor performed a count of IL (papules, pustules, nodular lesions), non-ILs (open and closed comedones) and total lesions (the sum of IL and non-IL) at each study visit. Lesion counts were confined to the face. Change from Baseline was calculated as the value at endpoint minus the value at Baseline. Data for adjusted mean has been reported. Percent change from Baseline is the change from Baseline divided by Baseline value multiplied by 100. The Baseline value was the latest pre-dose assessment value. The non-ILs were counted by diagnosis based on palpation of the investigator (or sub-investigator). A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.
Time frame: Baseline (Day 1) and Week 1, 4, 8, 12
Percent Change Form Baseline in Lesion Counts (ILs and Non-ILs) to Weeks 1, 2, 4, 8 and 12
The assessor performed a count of IL (papules, pustules, nodular lesions), non-ILs (open and closed comedones). Lesion counts were confined to the face. Change from Baseline was calculated as the value at endpoint minus the value at Baseline. Data for adjusted mean has been reported. Percent change from Baseline is the change from Baseline divided by Baseline value multiplied by 100. The Baseline value was the latest pre-dose assessment value. The non-ILs were counted by diagnosis based on palpation of the investigator (or sub-investigator).
Time frame: Baseline (Day 1) and Week 1, 2, 4, 8, 12
Absolute Change From Baseline in Lesion Counts (TLs, ILs and Non-ILs) to Weeks 1, 2, 4, 8 and 12
The assessor performed a count of IL (papules, pustules, nodular lesions), non-ILs (open and closed comedones) and total lesions (the sum of IL and non-IL) at each study visit. Lesion counts were confined to the face. Change from Baseline was calculated as the value at endpoint minus the value at Baseline. Data for adjusted mean has been reported. The non-ILs were counted by diagnosis based on palpation of the investigator (or sub-investigator). A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM. The Baseline value was the latest pre-dose assessment value.
Time frame: Baseline (Day 1) and Week 1, 2, 4, 8, 12
Percentage of Participants With a Minimum of 2-grade Improvement in Investigator's Static Global Assessment (ISGA) Score From Baseline to Weeks 1, 2, 4, 8 and 12
Responder was defined as participants with a minimum 2-grade improvement in ISGA score from Baseline. ISGA scale was scored from 0-5 (0= Clear skin with no inflammatory or non-ILs, 1= Almost clear: rare non-ILs present, with no more than rare papules, 2= Mild severity: greater than Grade 1, some non-ILs with no more than few inflammatory lesions, 3= Moderate severity: greater than Grade 2, many non-ILS, may have some ILs, but no more than 1 small nodular lesion, 4= Severe: greater than Grade 3, up to many non-ILs and ILs, but no more than a few nodular lesions, 5= Very severe: many non -ILs and ILs and more than a few nodular lesions. May have cystic lesions). Percentage of participants was calculated by dividing number of participants with 2-grade improvement in ISGA score from Baseline by total number of participants value multiplied by 100.
Time frame: Week 1, 2, 4, 8, 12
Percentage of Participants With ISGA Score of 0 or 1 at Weeks 1, 2, 4, 8 and 12
Responder was defined as participant with ISGA score of 0 or 1. ISGA scale was scored from 0-5 (0= Clear skin with no inflammatory or non-ILs, 1= Almost clear: rare non-ILs present, with no more than rare papules, 2= Mild severity: greater than Grade 1, some non-ILs with no more than few inflammatory lesions, 3= Moderate severity: greater than Grade 2, many non-ILS, may have some ILs, but no more than 1 small nodular lesion, 4= Severe: greater than Grade 3, up to many non-ILs and ILs, but no more than a few nodular lesions, 5= Very severe: many non -ILs and ILs and more than a few nodular lesions. May have cystic lesions). Percentage of participants was calculated by dividing number of participants with 0-1 ISGA score post Baseline by total number of participants value multiplied by 100.
Time frame: Week 1, 2, 4, 8 and 12
Percentage of Participants With at Least 50% Reduction in Lesion Counts (TLs, ILs and Non-ILs) From Baseline at Weeks 1, 2, 4, 8 and 12
Responder was defined as participants with at least a 50% reduction in TLs, ILs and non-ILs. Data for number of participants is reported. Percentage of participants was calculated by dividing number of responders by total number of participants value multiplied by 100.
Time frame: Week 1, 2, 4, 8 and 12
Number of Participants With Treatment Adherence Rate at Weeks 1, 2, 4, 8 and 12
The investigator (or sub-investigator), the product storage manager, or the blinded coordinator dispensed a study compliance log to record participant's compliance with investigational product application from Baseline to the end of study treatment. The product storage manager or the blinded coordinator evaluated the participant's compliance with study treatment, using the study compliance log at each visit, and recorded the compliance data in the eCRF.
Time frame: Week 1, 2, 4, 8 and 12
Number of Participants Who Continued Treatment at Weeks 1, 2, 4, 8 and 12
Number of participants who continued the treatment till Week 12 was measured. Overall data for participants who have not missed any dose during the treatment period has been reported.
Time frame: Up to Week 12
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Participants had to rate each question on a 5-point scale of 0 to 4 (4: yes, very easy to use, 3: yes, easy, 2: slightly easy, 1: slightly difficult, 0: No) where larger score indicates more preferable participant's feeling. There were 5 questions in the questionnaire: ease of application, comfort, satisfaction with treatment (ST), comparison with prior therapies (CPT) and willingness to continue using the product (WCP).
Time frame: Week 1, 2, 4, 8 and 12
Change From Baseline in Quality of Life (QoL) Score at Week 2, 4, 8 and 12
QOL questionnaire was assessed using Skindex-16 with 16 questions in 3 multi-item scales: symptoms, emotions and functioning for the past week: skin condition-itching, burning or stinging, hurting, being irritated, persistence/reoccurrence of skin condition, worry about condition, appearance of skin, frustration about skin, embarrassment about skin, being annoyed about your skin, feeling depressed about skin, effects of your skin on your interactions with others, effects of your skin condition on your desire to be with people, skin condition making it hard to show affection, effects of your skin condition on your daily activities and skin condition making it hard to work or do what you enjoy. Data for adjusted mean has been reported. The Baseline value was the latest pre-dose assessment value. Change from Baseline was calculated as the value at endpoint minus the value at Baseline. Scores range from 0-never bothered to 100-always bothered.
Time frame: Baseline(Day 1) and Week 2, 4, 8 and 12
Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A SAE is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. Medical or scientific judgment was exercised in deciding whether reporting was appropriate. For liver injury and impaired liver function, alanine aminotransferase greater than or equal to (\>=)3 times upper limit of normal (ULN) and total bilirubin \>=2xULN (less than \[\>\] 35% direct) was defined.
Time frame: Up to Week 12
Local Tolerability Score for Erythema, Dryness, Peeling, Itching, and Burning or Stinging
Local tolerability score for erythema (no redness, faint red or pink coloration, barely perceptible, light red or pink coloration, medium red coloration, beet red coloration), dryness (none, barely perceptible dryness with no flakes or fissure formation, easily perceptible dryness with no flakes or fissure formation, easily noted dryness and flakes but no fissure formation, easily noted dryness with flakes and fissure formation), peeling (no peeling, mild localized peeling, mild and diffuse peeling, moderate and diffuse peeling, moderate to prominent, dense peeling) and itching and burning/stinging (normal-no discomfort, noticeable discomfort that causes intermittent awareness, continuous awareness, intermittent awareness and interferes occasionally with normal daily activities, a definite continuous discomfort that interferes with normal daily activities) was assessed on a scale of 0 to 4 (0= absent, 1= slight, 2= mild, 3= moderate and 4= severe).
Time frame: Week 1, 2, 4, 8 and 12
Number of Participants With Severity of AEs
The severity of AEs was assessed by the investigator; events were assigned to one of the following categories: mild, an event that was easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities; moderate, an event that was sufficiently discomforting to interfere with normal everyday activities; and severe, an event that prevented normal everyday activities.
Time frame: Up to Week 12
DUAC® (clindamycin phosphate 1.2 percent \[%\] + benzoyl peroxide 3%) is the registered product of GlaxoSmithKline. This study was conducted between 07 October 2015 and 17 February 2016 in which 349 participants were randomized.
| Milestone | DUAC | ADA 0.1% +CLDM 1% |
|---|---|---|
| Started | 172 | 177 |
| Completed | 165 | 169 |
| Not completed | 7 | 8 |
| Withdrew: Adverse event | 6 | 5 |
| Withdrew: Protocol violation | 0 | 1 |
| Withdrew: Protocol-defined stopping criteria | 0 | 1 |
| Withdrew: Withdrawal by subject | 1 | 1 |
The assessor performed a count of IL (papules, pustules, nodular lesions), non-ILs (open and closed comedones) and total lesions (the sum of IL and non-IL) at each study visit. Lesion counts were confined to the face. Change from Baseline was calculated as the value at endpoint minus the value at Baseline. Data for adjusted mean has been reported. Percent change from Baseline is the change from Baseline divided by Baseline value multiplied by 100. The Baseline value was the latest pre-dose assessment value. The non-inflammatory lesions were counted by diagnosis based on palpation of the investigator (or sub-investigator).
| Percent change in lesions | DUAC | ADA 0.1% +CLDM 1% |
|---|---|---|
| Percent Change in Total Lesion Counts (TLs) From Baseline to Week 2 | -42.16 ± 1.890 | -35.33 ± 1.850 |
The assessor performed a count of IL (papules, pustules, nodular lesions), non-ILs (open and closed comedones) and total lesions (the sum of IL and non-IL) at each study visit. Lesion counts were confined to the face. Change from Baseline was calculated as the value at endpoint minus the value at Baseline. Data for adjusted mean has been reported. Percent change from Baseline is the change from Baseline divided by Baseline value multiplied by 100. The Baseline value was the latest pre-dose assessment value. The non-ILs were counted by diagnosis based on palpation of the investigator (or sub-investigator). A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.
| Percent change in lesions | DUAC | ADA 0.1% +CLDM 1% |
|---|---|---|
| Week 1 | -24.58 ± 1.729 | -24.33 ± 1.697 |
| Week 4 | -55.51 ± 1.670 | -49.65 ± 1.637 |
| Week 8 | -65.23 ± 1.544 | -62.88 ± 1.514 |
| Week 12 | -74.60 ± 1.314 | -71.36 ± 1.288 |
The assessor performed a count of IL (papules, pustules, nodular lesions), non-ILs (open and closed comedones). Lesion counts were confined to the face. Change from Baseline was calculated as the value at endpoint minus the value at Baseline. Data for adjusted mean has been reported. Percent change from Baseline is the change from Baseline divided by Baseline value multiplied by 100. The Baseline value was the latest pre-dose assessment value. The non-ILs were counted by diagnosis based on palpation of the investigator (or sub-investigator).
| Percent change in lesions | DUAC | ADA 0.1% +CLDM 1% |
|---|---|---|
| Week 1 ILs | -42.97 ± 2.349 | -37.89 ± 2.309 |
| Week 2 ILs | -60.92 ± 2.209 | -52.49 ± 2.162 |
| Week 4 ILs | -70.68 ± 1.898 | -61.30 ± 1.860 |
| Week 8 ILs | -76.33 ± 1.717 | -69.64 ± 1.682 |
| Week 12 ILs | -82.07 ± 1.403 | -77.58 ± 1.374 |
| Week 1 non-ILs | -15.13 ± 2.279 | -17.85 ± 2.239 |
| Week 2 non-ILs | -32.71 ± 2.419 | -27.01 ± 2.367 |
| Week 4 non-ILs | -47.64 ± 2.171 | -43.74 ± 2.129 |
| Week 8 non-ILs | -59.50 ± 1.910 | -58.91 ± 1.872 |
| Week 12 non-ILs | -71.07 ± 1.603 | -67.29 ± 1.571 |
The assessor performed a count of IL (papules, pustules, nodular lesions), non-ILs (open and closed comedones) and total lesions (the sum of IL and non-IL) at each study visit. Lesion counts were confined to the face. Change from Baseline was calculated as the value at endpoint minus the value at Baseline. Data for adjusted mean has been reported. The non-ILs were counted by diagnosis based on palpation of the investigator (or sub-investigator). A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM. The Baseline value was the latest pre-dose assessment value.
| lesion count | DUAC | ADA 0.1% +CLDM 1% |
|---|---|---|
| Week 1 TLs | -24.4 ± 1.70 | -24.3 ± 1.67 |
| Week 2 TLs | -41.8 ± 1.88 | -35.6 ± 1.84 |
| Week 4 TLs | -56.3 ± 1.71 | -51.6 ± 1.67 |
| Week 8 TLs | -66.4 ± 1.60 | -65.7 ± 1.57 |
| Week 12 TLs | -76.2 ± 1.37 | -74.5 ± 1.34 |
| Week 1 ILs | -13.3 ± 0.74 | -11.5 ± 0.72 |
| Week 2 ILs | -19.3 ± 0.70 | -16.3 ± 0.68 |
| Week 4 ILs | -22.4 ± 0.62 | -19.8 ± 0.60 |
| Week 8 ILs | -24.3 ± 0.56 | -22.4 ± 0.55 |
| Week 12 ILs | -26.0 ± 0.48 | -24.9 ± 0.47 |
| Week 1 non-ILs | -11.1 ± 1.46 | -12.9 ± 1.43 |
| Week 2 non-ILs | -22.5 ± 1.59 | -19.3 ± 1.56 |
| Week 4 non-ILs | -34.0 ± 1.46 | -32.0 ± 1.44 |
| Week 8 non-ILs | -42.2 ± 1.33 | -43.4 ± 1.31 |
| Week 12 non-ILs | -50.2 ± 1.11 | -49.6 ± 1.09 |
Responder was defined as participants with a minimum 2-grade improvement in ISGA score from Baseline. ISGA scale was scored from 0-5 (0= Clear skin with no inflammatory or non-ILs, 1= Almost clear: rare non-ILs present, with no more than rare papules, 2= Mild severity: greater than Grade 1, some non-ILs with no more than few inflammatory lesions, 3= Moderate severity: greater than Grade 2, many non-ILS, may have some ILs, but no more than 1 small nodular lesion, 4= Severe: greater than Grade 3, up to many non-ILs and ILs, but no more than a few nodular lesions, 5= Very severe: many non -ILs and ILs and more than a few nodular lesions. May have cystic lesions). Percentage of participants was calculated by dividing number of participants with 2-grade improvement in ISGA score from Baseline by total number of participants value multiplied by 100.
| Percentage of participants | DUAC | ADA 0.1% +CLDM 1% |
|---|---|---|
| Week 1 | 2 | 0 |
| Week 2 | 6 | 3 |
| Week 4 | 12 | 8 |
| Week 8 | 22 | 12 |
| Week 12 | 37 | 27 |
Responder was defined as participant with ISGA score of 0 or 1. ISGA scale was scored from 0-5 (0= Clear skin with no inflammatory or non-ILs, 1= Almost clear: rare non-ILs present, with no more than rare papules, 2= Mild severity: greater than Grade 1, some non-ILs with no more than few inflammatory lesions, 3= Moderate severity: greater than Grade 2, many non-ILS, may have some ILs, but no more than 1 small nodular lesion, 4= Severe: greater than Grade 3, up to many non-ILs and ILs, but no more than a few nodular lesions, 5= Very severe: many non -ILs and ILs and more than a few nodular lesions. May have cystic lesions). Percentage of participants was calculated by dividing number of participants with 0-1 ISGA score post Baseline by total number of participants value multiplied by 100.
| Percentage of participants | DUAC | ADA 0.1% +CLDM 1% |
|---|---|---|
| Week 1 | 2 | 1 |
| Week 2 | 6 | 5 |
| Week 4 | 13 | 6 |
| Week 8 | 20 | 12 |
| Week 12 | 41 | 29 |
Responder was defined as participants with at least a 50% reduction in TLs, ILs and non-ILs. Data for number of participants is reported. Percentage of participants was calculated by dividing number of responders by total number of participants value multiplied by 100.
| Percentage of participants | DUAC | ADA 0.1% +CLDM 1% |
|---|---|---|
| Week 1 TLs | 22 | 18 |
| Week 2 TLs | 47 | 42 |
| Week 4 TLs | 67 | 60 |
| Week 8 TLs | 81 | 81 |
| Week 12 TLs | 88 | 86 |
| Week 1 ILs | 51 | 42 |
| Week 2 ILs | 77 | 66 |
| Week 4 ILs | 85 | 76 |
| Week 8 ILs | 87 | 84 |
| Week 12 ILs | 92 | 89 |
| Week 1 non-ILs | 14 | 16 |
| Week 2 non-ILs | 37 | 34 |
| Week 4 non-ILs | 58 | 54 |
| Week 8 non-ILs | 73 | 73 |
| Week 12 non-ILs | 83 | 80 |
The investigator (or sub-investigator), the product storage manager, or the blinded coordinator dispensed a study compliance log to record participant's compliance with investigational product application from Baseline to the end of study treatment. The product storage manager or the blinded coordinator evaluated the participant's compliance with study treatment, using the study compliance log at each visit, and recorded the compliance data in the eCRF.
| Participants | DUAC | ADA 0.1% +CLDM 1% |
|---|---|---|
| week 1 | 143 | 131 |
| week 2 | 125 | 115 |
| week 4 | 110 | 85 |
| week 8 | 89 | 72 |
| week 12 | 88 | 63 |
Number of participants who continued the treatment till Week 12 was measured. Overall data for participants who have not missed any dose during the treatment period has been reported.
| Participants | DUAC | ADA 0.1% +CLDM 1% |
|---|---|---|
| Number of Participants Who Continued Treatment at Weeks 1, 2, 4, 8 and 12 | 63 | 59 |
Participants had to rate each question on a 5-point scale of 0 to 4 (4: yes, very easy to use, 3: yes, easy, 2: slightly easy, 1: slightly difficult, 0: No) where larger score indicates more preferable participant's feeling. There were 5 questions in the questionnaire: ease of application, comfort, satisfaction with treatment (ST), comparison with prior therapies (CPT) and willingness to continue using the product (WCP).
| Participants | DUAC | ADA 0.1% +CLDM 1% |
|---|---|---|
| Week 1: Ease of application, Score 4 | 131 | 95 |
| Week 1: Ease of application, Score 3 | 38 | 66 |
| Week 1: Ease of application, Score 2 | 2 | 13 |
| Week 1: Ease of application, Score 1 | 1 | 2 |
| Week 2: Ease of application, Score 4 | 128 | 83 |
| Week 2: Ease of application, Score 3 | 38 | 75 |
| Week 2: Ease of application, Score 2 | 2 | 17 |
| Week 2: Ease of application, Score 1 | 1 | 1 |
| Week 4: Ease of application, Score 4 | 118 | 85 |
| Week 4: Ease of application, Score 3 | 49 | 70 |
| Week 4: Ease of application, Score 2 | 2 | 18 |
| Week 4: Ease of application, Score 1 | 0 | 1 |
| Week 8: Ease of application, Score 4 | 114 | 90 |
| Week 8: Ease of application, Score 3 | 50 | 60 |
| Week 8: Ease of application, Score 2 | 3 | 19 |
| Week 8: Ease of application, Score 1 | 0 | 3 |
| Week 12: Ease of application, Score 4 | 116 | 81 |
| Week 12: Ease of application, Score 3 | 44 | 68 |
| Week 12: Ease of application, Score 2 | 4 | 18 |
| Week 12: Ease of application, Score 1 | 0 | 2 |
| Week 1: Comfort, Score 4 | 37 | 24 |
| Week 1: Comfort, Score 3 | 86 | 69 |
| Week 1: Comfort, Score 2 | 37 | 45 |
| Week 1: Comfort, Score 1 | 7 | 32 |
| Week 1: Comfort, Score 0 | 5 | 6 |
| Week 2: Comfort, Score 4 | 56 | 35 |
| Week 2: Comfort, Score 3 | 70 | 81 |
| Week 2: Comfort, Score 2 | 36 | 42 |
| Week 2: Comfort, Score 1 | 6 | 17 |
| Week 2: Comfort, Score 0 | 1 | 1 |
| Week 4: Comfort, Score 4 | 72 | 47 |
| Week 4: Comfort, Score 3 | 75 | 80 |
| Week 4: Comfort, Score 2 | 17 | 31 |
| Week 4: Comfort, Score 1 | 5 | 15 |
| Week 4: Comfort, Score 0 | 0 | 1 |
| Week 8: Comfort, Score 4 | 79 | 53 |
| Week 8: Comfort, Score 3 | 69 | 68 |
| Week 8: Comfort, Score 2 | 18 | 36 |
| Week 8: Comfort, Score 1 | 1 | 13 |
| Week 8: Comfort, Score 0 | 0 | 2 |
| Week 12: Comfort, Score 4 | 84 | 56 |
| Week 12: Comfort, Score 3 | 66 | 73 |
| Week 12: Comfort, Score 2 | 13 | 26 |
| Week 12: Comfort, Score 1 | 1 | 13 |
| Week 12: Comfort, Score 0 | 0 | 1 |
| Week 1: ST, Score 4 | 36 | 21 |
| Week 1: ST, Score 3 | 79 | 75 |
| Week 1: ST, Score 2 | 46 | 49 |
| Week 1: ST, Score 1 | 11 | 23 |
| Week 1: ST, Score 0 | 0 | 8 |
| Week 2: ST, Score 4 | 58 | 38 |
| Week 2: ST, Score 3 | 70 | 81 |
| Week 2: ST, Score 2 | 37 | 47 |
| Week 2: ST, Score 1 | 4 | 7 |
| Week 2: ST, Score 0 | 0 | 3 |
| Week 4: ST, Score 4 | 66 | 44 |
| Week 4: ST, Score 3 | 72 | 81 |
| Week 4: ST, Score 2 | 27 | 40 |
| Week 4: ST, Score 1 | 4 | 8 |
| Week 4: ST, Score 0 | 0 | 1 |
| Week 8: ST, Score 4 | 78 | 58 |
| Week 8: ST, Score 3 | 67 | 72 |
| Week 8: ST, Score 2 | 17 | 33 |
| Week 8: ST, Score 1 | 5 | 6 |
| Week 8: ST, Score 0 | 0 | 3 |
| Week 12: ST, Score 4 | 82 | 63 |
| Week 12: ST, Score 3 | 61 | 70 |
| Week 12: ST, Score 2 | 20 | 29 |
| Week 12: ST, Score 1 | 1 | 6 |
| Week 12: ST, Score 0 | 0 | 1 |
| Week 1: CPT, Score 4 | 77 | 53 |
| Week 1: CPT, Score 3 | 50 | 45 |
| Week 1: CPT, Score 2 | 38 | 61 |
| Week 1: CPT, Score 1 | 7 | 11 |
| Week 1: CPT, Score 0 | 0 | 6 |
| Week 2: CPT, Score 4, | 90 | 57 |
| Week 2: CPT, Score 3 | 51 | 55 |
| Week 2: CPT, Score 2 | 25 | 54 |
| Week 2: CPT, Score 1 | 2 | 10 |
| Week 2: CPT, Score 0 | 1 | 0 |
| Week 4: CPT, Score 4 | 100 | 67 |
| Week 4: CPT, Score 3 | 47 | 52 |
| Week 4: CPT, Score 2 | 18 | 46 |
| Week 4: CPT, Score 1 | 4 | 8 |
| Week 4: CPT, Score 0 | 0 | 1 |
| Week 8: CPT, Score 4 | 109 | 73 |
| Week 8: CPT, Score 3 | 38 | 50 |
| Week 8: CPT, Score 2 | 19 | 40 |
| Week 8: CPT, Score 1 | 1 | 8 |
| Week 8: CPT, Score 0 | 0 | 1 |
| Week 12: CPT, Score 4 | 112 | 78 |
| Week 12: CPT, Score 3 | 42 | 47 |
| Week 12: CPT, Score 2 | 8 | 35 |
| Week 12: CPT, Score 1 | 2 | 7 |
| Week 12: CPT, Score 0 | 0 | 2 |
| Week 1: WCP, Score 4 | 64 | 36 |
| Week 1: WCP, Score 3 | 79 | 78 |
| Week 1: WCP, Score 2 | 25 | 39 |
| Week 1: WCP, Score 1 | 4 | 19 |
| Week 1: WCP, Score 0 | 0 | 4 |
| Week 2: WCP, Score 4 | 75 | 55 |
| Week 2: WCP, Score 3 | 72 | 70 |
| Week 2: WCP, Score 2 | 19 | 38 |
| Week 2: WCP, Score 1 | 3 | 13 |
| Week 4: WCP, Score 4 | 88 | 63 |
| Week 4: WCP, Score 3 | 63 | 75 |
| Week 4: WCP, Score 2 | 15 | 26 |
| Week 4: WCP, Score 1 | 3 | 10 |
| Week 8: WCP, Score 4 | 90 | 62 |
| Week 8: WCP, Score 3 | 59 | 74 |
| Week 8: WCP, Score 2 | 15 | 27 |
| Week 8: WCP, Score 1 | 3 | 9 |
| Week 12: WCP, Score 4 | 94 | 70 |
| Week 12: WCP, Score 3 | 56 | 65 |
| Week 12: WCP, Score 2 | 12 | 23 |
| Week 12: WCP, Score 1 | 1 | 11 |
| Week 12: WCP, Score 0 | 1 | 0 |
QOL questionnaire was assessed using Skindex-16 with 16 questions in 3 multi-item scales: symptoms, emotions and functioning for the past week: skin condition-itching, burning or stinging, hurting, being irritated, persistence/reoccurrence of skin condition, worry about condition, appearance of skin, frustration about skin, embarrassment about skin, being annoyed about your skin, feeling depressed about skin, effects of your skin on your interactions with others, effects of your skin condition on your desire to be with people, skin condition making it hard to show affection, effects of your skin condition on your daily activities and skin condition making it hard to work or do what you enjoy. Data for adjusted mean has been reported. The Baseline value was the latest pre-dose assessment value. Change from Baseline was calculated as the value at endpoint minus the value at Baseline. Scores range from 0-never bothered to 100-always bothered.
| Score on scale | DUAC | ADA 0.1% +CLDM 1% |
|---|---|---|
| Week 2 | -0.71 ± 0.070 | -0.49 ± 0.068 |
| Week 4 | -1.02 ± 0.069 | -0.80 ± 0.068 |
| Week 8 | -1.14 ± 0.073 | -0.92 ± 0.071 |
| Week 12 | -1.27 ± 0.073 | -1.10 ± 0.072 |
An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A SAE is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. Medical or scientific judgment was exercised in deciding whether reporting was appropriate. For liver injury and impaired liver function, alanine aminotransferase greater than or equal to (\>=)3 times upper limit of normal (ULN) and total bilirubin \>=2xULN (less than \[\>\] 35% direct) was defined.
| Participants | DUAC | ADA 0.1% +CLDM 1% |
|---|---|---|
| Any AE | 53 | 100 |
| Any SAE | 1 | 0 |
Local tolerability score for erythema (no redness, faint red or pink coloration, barely perceptible, light red or pink coloration, medium red coloration, beet red coloration), dryness (none, barely perceptible dryness with no flakes or fissure formation, easily perceptible dryness with no flakes or fissure formation, easily noted dryness and flakes but no fissure formation, easily noted dryness with flakes and fissure formation), peeling (no peeling, mild localized peeling, mild and diffuse peeling, moderate and diffuse peeling, moderate to prominent, dense peeling) and itching and burning/stinging (normal-no discomfort, noticeable discomfort that causes intermittent awareness, continuous awareness, intermittent awareness and interferes occasionally with normal daily activities, a definite continuous discomfort that interferes with normal daily activities) was assessed on a scale of 0 to 4 (0= absent, 1= slight, 2= mild, 3= moderate and 4= severe).
| Score on scale | DUAC | ADA 0.1% +CLDM 1% |
|---|---|---|
| Erythema Week 1 | 0.0 ± 0.61 | 0.3 ± 0.72 |
| Erythema Week 2 | 0.0 ± 0.68 | 0.0 ± 0.70 |
| Erythema Week 4 | -0.1 ± 0.57 | -0.1 ± 0.64 |
| Erythema Week 8 | -0.2 ± 0.68 | -0.2 ± 0.69 |
| Erythema Week 12 | -0.2 ± 0.78 | -0.3 ± 0.67 |
| Dryness Week 1 | 0.1 ± 0.54 | 0.6 ± 0.95 |
| Dryness Week 2 | 0.0 ± 0.50 | 0.1 ± 0.58 |
| Dryness Week 4 | 0.0 ± 0.52 | 0.1 ± 0.49 |
| Dryness Week 8 | 0.0 ± 0.58 | 0.1 ± 0.46 |
| Dryness Week 12 | 0.0 ± 0.45 | 0.0 ± 0.35 |
| Peeling Week 1 | 0.1 ± 0.43 | 0.5 ± 0.88 |
| Peeling Week 2 | 0.1 ± 0.33 | 0.2 ± 0.55 |
| Peeling Week 4 | 0.0 ± 0.34 | 0.1 ± 0.42 |
| Peeling Week 8 | 0.1 ± 0.39 | 0.1 ± 0.46 |
| Peeling Week 12 | 0.0 ± 0.31 | 0.0 ± 0.32 |
| Itching Week 1 | 0.0 ± 0.64 | 0.1 ± 0.81 |
| Itching Week 2 | 0.0 ± 0.60 | 0.1 ± 0.77 |
| Itching Week 4 | -0.1 ± 0.68 | -0.1 ± 0.62 |
| Itching Week 8 | -0.2 ± 0.63 | -0.1 ± 0.58 |
| Itching Week 12 | -0.2 ± 0.66 | -0.2 ± 0.56 |
| Burning/Stinging Week 1 | 0.0 ± 0.48 | 0.5 ± 0.85 |
| Burning/Stinging Week 2 | 0.0 ± 0.44 | 0.2 ± 0.66 |
| Burning/Stinging Week 4 | 0.0 ± 0.44 | 0.0 ± 0.47 |
| Burning/Stinging Week 8 | 0.0 ± 0.34 | 0.1 ± 0.53 |
| Burning/Stinging Week 12 | 0.0 ± 0.39 | 0.0 ± 0.40 |
The severity of AEs was assessed by the investigator; events were assigned to one of the following categories: mild, an event that was easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities; moderate, an event that was sufficiently discomforting to interfere with normal everyday activities; and severe, an event that prevented normal everyday activities.
| Participants | DUAC | ADA 0.1% +CLDM 1% |
|---|---|---|
| Mild | 46 | 91 |
| Modertae | 6 | 7 |
| Severe | 1 | 2 |
Collected over AE and SAE were collected up to Week 12.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Duac | — | 1/172 (0.6%) | 34/172 (19.8%) |
| ADA 0.1% +CLDM 1% | — | 0/177 (0%) | 78/177 (44.1%) |
| Event | Duac | ADA 0.1% +CLDM 1% |
|---|---|---|
| Duodenal ulcerGastrointestinal disorders | 1/172 | 0/177 |
| Event | Duac | ADA 0.1% +CLDM 1% |
|---|---|---|
| Application site drynessGeneral disorders | 16/172 | 44/177 |
| Application site painGeneral disorders | 3/172 | 20/177 |
| NasopharyngitisInfections and infestations | 12/172 | 15/177 |
| Application site erythemaGeneral disorders | 4/172 | 11/177 |
| EczemaSkin and subcutaneous tissue disorders | 2/172 | 10/177 |
| Age, Continuous(Years) | DUAC | ADA 0.1% +CLDM 1% | Total |
|---|---|---|---|
| Mean | 20.3 ± 5.91 | 19.8 ± 4.90 | 20.0 ± 5.42 |
| Sex: Female, Male(Participants) | DUAC | ADA 0.1% +CLDM 1% | Total |
|---|---|---|---|
| Female | 97 | 110 | 207 |
| Male | 75 | 67 | 142 |
| Race (NIH/OMB)(Participants) | DUAC | ADA 0.1% +CLDM 1% | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 172 | 177 | 349 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
Plan to share: Yes — IPD for this study will be made available via the Clinical Study Data Request site.
Supporting information: Study protocol, Sap, Icf, Csr
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