Trial Outcomes & Findings for A Study Comparing Aczone® Plus Differin® Versus Duac® Plus Differin® in Patients With Severe Facial Acne (NCT NCT01231334)
NCT ID: NCT01231334
Last Updated: 2012-07-27
Results Overview
GAAS was conducted by the investigator at Baseline and Week 12. The patient's facial acne was evaluated on a 5 point scale 0=None (no evidence of acne), 1=Minimal (few lesions), 2=Mild (several to many non-inflammatory lesions; few inflammatory lesions), 3=Moderate (many lesions) to 4=Severe (Significant degree of inflammatory disease; papules/pustules present, few nodulo-cystic lesions; comedones may be present). Papules/nodules are round, solid elevations of the skin with no visible fluid. The percentage of participants with at least a one point decrease (improvement) in GAAS was calculated.
COMPLETED
PHASE4
286 participants
Baseline, Week 12
2012-07-27
Participant Flow
Participant milestones
| Measure |
Aczone® Gel 5% Plus Differin® 0.3% Gel
Dapsone (Aczone® Gel 5%) applied to entire face in the morning. Adapalene (Differin® 0.3% Gel)followed by Dapsone (Aczone® Gel 5%) applied to entire face in the evening. Daily treatment for 12 weeks
|
Duac® Topical Gel Plus Differin® 0.3% Gel
Clindamycin/benzoyl peroxide (Duac® Topical Gel)applied to entire face in the morning. Adapalene (Differin® 0.3% Gel) applied to entire face in the evening. Daily treatment for 12 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
145
|
141
|
|
Overall Study
COMPLETED
|
126
|
120
|
|
Overall Study
NOT COMPLETED
|
19
|
21
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study Comparing Aczone® Plus Differin® Versus Duac® Plus Differin® in Patients With Severe Facial Acne
Baseline characteristics by cohort
| Measure |
Aczone® Gel 5% Plus Differin® 0.3% Gel
n=145 Participants
Dapsone (Aczone® Gel 5%) applied to entire face in the morning. Adapalene (Differin® 0.3% Gel)followed by Dapsone (Aczone® Gel 5%) applied to entire face in the evening. Daily treatment for 12 weeks
|
Duac® Topical Gel Plus Differin® 0.3% Gel
n=141 Participants
Clindamycin/benzoyl peroxide (Duac® Topical Gel)applied to entire face in the morning. Adapalene (Differin® 0.3% Gel) applied to entire face in the evening. Daily treatment for 12 weeks.
|
Total
n=286 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
27.2 Years
STANDARD_DEVIATION 6.5 • n=5 Participants
|
27.9 Years
STANDARD_DEVIATION 7.1 • n=7 Participants
|
27.6 Years
STANDARD_DEVIATION 6.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
145 Participants
n=5 Participants
|
141 Participants
n=7 Participants
|
286 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: Per-Protocol Population consists of all randomized participants who completed the study to week 12 without any major protocol violation.
GAAS was conducted by the investigator at Baseline and Week 12. The patient's facial acne was evaluated on a 5 point scale 0=None (no evidence of acne), 1=Minimal (few lesions), 2=Mild (several to many non-inflammatory lesions; few inflammatory lesions), 3=Moderate (many lesions) to 4=Severe (Significant degree of inflammatory disease; papules/pustules present, few nodulo-cystic lesions; comedones may be present). Papules/nodules are round, solid elevations of the skin with no visible fluid. The percentage of participants with at least a one point decrease (improvement) in GAAS was calculated.
Outcome measures
| Measure |
Aczone® Gel 5% Plus Differin® 0.3% Gel
n=122 Participants
Dapsone (Aczone® Gel 5%) applied to entire face in the morning. Adapalene (Differin® 0.3% Gel)followed by Dapsone (Aczone® Gel 5%) applied to entire face in the evening. Daily treatment for 12 weeks
|
Duac® Topical Gel Plus Differin® 0.3% Gel
n=118 Participants
Clindamycin/benzoyl peroxide (Duac® Topical Gel)applied to entire face in the morning. Adapalene (Differin® 0.3% Gel) applied to entire face in the evening. Daily treatment for 12 weeks.
|
|---|---|---|
|
Percentage of Participants With at Least a One Point Decrease in the Global Acne Assessment Score (GAAS) at Week 12
|
69.7 Percentage of participants
|
81.4 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Per-Protocol Population consists of all randomized participants who completed the study to week 12 without any major protocol violation.
GAAS was conducted by the investigator. The patient's facial acne was evaluated on a 5 point scale 0=None (no evidence of acne), 1=Minimal (few lesions), 2=Mild (several to many non-inflammatory lesions; few inflammatory lesions), 3=Moderate (many lesions) to 4=Severe (Significant degree of inflammatory disease; papules/pustules present, few nodulo-cystic lesions; comedones may be present). Papules and nodules are round, solid elevations of the skin with no visible fluid. A negative change from baseline indicates improvement.
Outcome measures
| Measure |
Aczone® Gel 5% Plus Differin® 0.3% Gel
n=122 Participants
Dapsone (Aczone® Gel 5%) applied to entire face in the morning. Adapalene (Differin® 0.3% Gel)followed by Dapsone (Aczone® Gel 5%) applied to entire face in the evening. Daily treatment for 12 weeks
|
Duac® Topical Gel Plus Differin® 0.3% Gel
n=118 Participants
Clindamycin/benzoyl peroxide (Duac® Topical Gel)applied to entire face in the morning. Adapalene (Differin® 0.3% Gel) applied to entire face in the evening. Daily treatment for 12 weeks.
|
|---|---|---|
|
Change From Baseline in Global Acne Assessment Score (GAAS) at Week 12
Baseline
|
2.80 Score on a scale
Standard Deviation 0.51
|
2.84 Score on a scale
Standard Deviation 0.45
|
|
Change From Baseline in Global Acne Assessment Score (GAAS) at Week 12
Change from baseline at Week 12
|
-0.87 Score on a scale
Standard Deviation 0.82
|
-1.27 Score on a scale
Standard Deviation 0.82
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Per-Protocol Population consists of all randomized participants who completed the study to week 12 without any major protocol violation.
The overall disease severity was evaluated by the investigator at Baseline and Week 12 using a 7-point scale to rate the overall acne severity (lesions, inflammation, facial redness and skin condition), where 0=no acne lesions and 6=most severe acne. The percentage of participants with at least a one point decrease (improvement) from baseline is calculated.
Outcome measures
| Measure |
Aczone® Gel 5% Plus Differin® 0.3% Gel
n=122 Participants
Dapsone (Aczone® Gel 5%) applied to entire face in the morning. Adapalene (Differin® 0.3% Gel)followed by Dapsone (Aczone® Gel 5%) applied to entire face in the evening. Daily treatment for 12 weeks
|
Duac® Topical Gel Plus Differin® 0.3% Gel
n=118 Participants
Clindamycin/benzoyl peroxide (Duac® Topical Gel)applied to entire face in the morning. Adapalene (Differin® 0.3% Gel) applied to entire face in the evening. Daily treatment for 12 weeks.
|
|---|---|---|
|
Percentage of Participants at Week 12 Having at Least a One Point Decrease in Overall Disease Severity
|
83.5 Percentage of participants
|
92.4 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Per-Protocol Population consists of all randomized participants who completed the study to week 12 without any major protocol violation.
Percent Change from baseline in inflammatory lesion counts (papules, pustules and nodules) at week 12. Papules and nodules are round, solid elevations of the skin with no visible fluid; papules are smaller (less than 5 or 10 millimeters in width and depth) and nodules are larger (greater than 5 or 10 millimeters in width and depth). Pustules are small elevations of the skin containing cloudy material. A negative number change from baseline indicates a reduction in lesion counts (improvement).
Outcome measures
| Measure |
Aczone® Gel 5% Plus Differin® 0.3% Gel
n=122 Participants
Dapsone (Aczone® Gel 5%) applied to entire face in the morning. Adapalene (Differin® 0.3% Gel)followed by Dapsone (Aczone® Gel 5%) applied to entire face in the evening. Daily treatment for 12 weeks
|
Duac® Topical Gel Plus Differin® 0.3% Gel
n=118 Participants
Clindamycin/benzoyl peroxide (Duac® Topical Gel)applied to entire face in the morning. Adapalene (Differin® 0.3% Gel) applied to entire face in the evening. Daily treatment for 12 weeks.
|
|---|---|---|
|
Percent Change From Baseline in Inflammatory Lesion Counts at Week 12
|
-70.7 Percent change
Interval -100.0 to 38.1
|
-75.9 Percent change
Interval -100.0 to -17.4
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Per-Protocol Population consists of all randomized participants who completed the study to week 12 without any major protocol violation.
Percent Change from baseline in non-inflammatory lesion counts (open/closed comedones) at week 12. Comedones are small bumps on the skin (lesions) caused by acne and found at the opening of a skin pore. Open comedones (also known as a blackheads) have a microscopic opening to the skin surface, while closed comedones (also known as whiteheads or "pimples") lack the opening to the skin. A negative number change from baseline indicates a reduction in lesion counts (improvement).
Outcome measures
| Measure |
Aczone® Gel 5% Plus Differin® 0.3% Gel
n=122 Participants
Dapsone (Aczone® Gel 5%) applied to entire face in the morning. Adapalene (Differin® 0.3% Gel)followed by Dapsone (Aczone® Gel 5%) applied to entire face in the evening. Daily treatment for 12 weeks
|
Duac® Topical Gel Plus Differin® 0.3% Gel
n=118 Participants
Clindamycin/benzoyl peroxide (Duac® Topical Gel)applied to entire face in the morning. Adapalene (Differin® 0.3% Gel) applied to entire face in the evening. Daily treatment for 12 weeks.
|
|---|---|---|
|
Percent Change From Baseline in Non-inflammatory Lesion Counts at Week 12
|
-55.3 Percent change
Interval -100.0 to 115.0
|
-60.7 Percent change
Interval -100.0 to 31.6
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Per-Protocol Population consists of all randomized participants who completed the study to week 12 without any major protocol violation.
Percent change in total lesion counts: inflammatory (papules, pustules and nodules) and non-inflammatory (comedones) lesion counts from baseline. Papules and nodules are round, solid elevations of the skin with no visible fluid; papules are smaller (less than 5 or 10 millimeters ) and nodules are larger (greater than 5 or 10 millimeters). Pustules are small elevations of the skin containing cloudy material. Comedones are small bumps on the skin caused by acne and found at the opening of a skin pore. A negative change from baseline indicates a reduction in lesion counts (improvement).
Outcome measures
| Measure |
Aczone® Gel 5% Plus Differin® 0.3% Gel
n=122 Participants
Dapsone (Aczone® Gel 5%) applied to entire face in the morning. Adapalene (Differin® 0.3% Gel)followed by Dapsone (Aczone® Gel 5%) applied to entire face in the evening. Daily treatment for 12 weeks
|
Duac® Topical Gel Plus Differin® 0.3% Gel
n=118 Participants
Clindamycin/benzoyl peroxide (Duac® Topical Gel)applied to entire face in the morning. Adapalene (Differin® 0.3% Gel) applied to entire face in the evening. Daily treatment for 12 weeks.
|
|---|---|---|
|
Percent Change From Baseline in Total Lesion Count at Week 12
|
-62.7 Percent change
Full Range 27.0 • Interval -98.0 to 75.6
|
-65.0 Percent change
Full Range 22.5 • Interval -100.0 to 8.5
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Per-Protocol Population consists of all randomized participants who completed the study to week 12 without any major protocol violation.
The investigator rated the patient's current symptoms of erythema, dryness, peeling, and oiliness on a 5 point scale from 0 (Absent) to 4 (Severe). The investigator rated the symptoms of pruritus and burning since last visit on a 6 point scale of 0 (Absent) to 5 (Severe)-interfering with daily activities. Percentage of participants demonstrating a ≥1 category increase (improvement) in tolerability from baseline is calculated.
Outcome measures
| Measure |
Aczone® Gel 5% Plus Differin® 0.3% Gel
n=122 Participants
Dapsone (Aczone® Gel 5%) applied to entire face in the morning. Adapalene (Differin® 0.3% Gel)followed by Dapsone (Aczone® Gel 5%) applied to entire face in the evening. Daily treatment for 12 weeks
|
Duac® Topical Gel Plus Differin® 0.3% Gel
n=118 Participants
Clindamycin/benzoyl peroxide (Duac® Topical Gel)applied to entire face in the morning. Adapalene (Differin® 0.3% Gel) applied to entire face in the evening. Daily treatment for 12 weeks.
|
|---|---|---|
|
Percentage of Participants Demonstrating a ≥ 1 Category Increase in Tolerability From Baseline at Week 12
Dryness
|
21.3 Percentage of participants
|
11.9 Percentage of participants
|
|
Percentage of Participants Demonstrating a ≥ 1 Category Increase in Tolerability From Baseline at Week 12
Peeling
|
11.5 Percentage of participants
|
9.3 Percentage of participants
|
|
Percentage of Participants Demonstrating a ≥ 1 Category Increase in Tolerability From Baseline at Week 12
Oiliness
|
6.7 Percentage of participants
|
6.0 Percentage of participants
|
|
Percentage of Participants Demonstrating a ≥ 1 Category Increase in Tolerability From Baseline at Week 12
Erythema
|
8.2 Percentage of participants
|
6.8 Percentage of participants
|
|
Percentage of Participants Demonstrating a ≥ 1 Category Increase in Tolerability From Baseline at Week 12
Pruritus
|
12.4 Percentage of participants
|
8.5 Percentage of participants
|
|
Percentage of Participants Demonstrating a ≥ 1 Category Increase in Tolerability From Baseline at Week 12
Burning
|
13.2 Percentage of participants
|
12.7 Percentage of participants
|
Adverse Events
Aczone® Gel 5% Plus Differin® 0.3% Gel
Duac® Topical Gel Plus Differin® 0.3% Gel
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Aczone® Gel 5% Plus Differin® 0.3% Gel
n=136 participants at risk
Dapsone (Aczone® Gel 5%) applied to entire face in the morning. Adapalene (Differin® 0.3% Gel)followed by Dapsone (Aczone® Gel 5%) applied to entire face in the evening. Daily treatment for 12 weeks
|
Duac® Topical Gel Plus Differin® 0.3% Gel
n=135 participants at risk
Clindamycin/benzoyl peroxide (Duac® Topical Gel)applied to entire face in the morning. Adapalene (Differin® 0.3% Gel) applied to entire face in the evening. Daily treatment for 12 weeks.
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
11.0%
15/136
Safety population includes all participants who received study treatment.
|
5.2%
7/135
Safety population includes all participants who received study treatment.
|
|
Nervous system disorders
Headache
|
5.9%
8/136
Safety population includes all participants who received study treatment.
|
5.9%
8/135
Safety population includes all participants who received study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER