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Trial record 28 of 233 for:    acne AND Percent

A Study Comparing Aczone® Plus Differin® Versus Duac® Plus Differin® in Patients With Severe Facial Acne

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ClinicalTrials.gov Identifier: NCT01231334
Recruitment Status : Completed
First Posted : November 1, 2010
Results First Posted : July 27, 2012
Last Update Posted : July 27, 2012
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Condition Acne Vulgaris
Interventions Drug: Dapsone plus Adapalene
Drug: Clindamycin/benzoyl peroxide plus Adapalene
Enrollment 286
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Aczone® Gel 5% Plus Differin® 0.3% Gel Duac® Topical Gel Plus Differin® 0.3% Gel
Hide Arm/Group Description 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 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.
Period Title: Overall Study
Started 145 141
Completed 126 120
Not Completed 19 21
Arm/Group Title Aczone® Gel 5% Plus Differin® 0.3% Gel Duac® Topical Gel Plus Differin® 0.3% Gel Total
Hide Arm/Group Description 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 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 of all reporting groups
Overall Number of Baseline Participants 145 141 286
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 145 participants 141 participants 286 participants
27.2  (6.5) 27.9  (7.1) 27.6  (6.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 145 participants 141 participants 286 participants
Female
145
 100.0%
141
 100.0%
286
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Percentage of Participants With at Least a One Point Decrease in the Global Acne Assessment Score (GAAS) at Week 12
Hide Description 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.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Per-Protocol Population consists of all randomized participants who completed the study to week 12 without any major protocol violation.
Arm/Group Title Aczone® Gel 5% Plus Differin® 0.3% Gel Duac® Topical Gel Plus Differin® 0.3% Gel
Hide Arm/Group Description:
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
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 Number of Participants Analyzed 122 118
Measure Type: Number
Unit of Measure: Percentage of participants
69.7 81.4
2.Secondary Outcome
Title Change From Baseline in Global Acne Assessment Score (GAAS) at Week 12
Hide Description 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.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Per-Protocol Population consists of all randomized participants who completed the study to week 12 without any major protocol violation.
Arm/Group Title Aczone® Gel 5% Plus Differin® 0.3% Gel Duac® Topical Gel Plus Differin® 0.3% Gel
Hide Arm/Group Description:
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
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 Number of Participants Analyzed 122 118
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Baseline 2.80  (0.51) 2.84  (0.45)
Change from baseline at Week 12 -0.87  (0.82) -1.27  (0.82)
3.Secondary Outcome
Title Percentage of Participants at Week 12 Having at Least a One Point Decrease in Overall Disease Severity
Hide Description 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.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Per-Protocol Population consists of all randomized participants who completed the study to week 12 without any major protocol violation.
Arm/Group Title Aczone® Gel 5% Plus Differin® 0.3% Gel Duac® Topical Gel Plus Differin® 0.3% Gel
Hide Arm/Group Description:
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
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 Number of Participants Analyzed 122 118
Measure Type: Number
Unit of Measure: Percentage of participants
83.5 92.4
4.Secondary Outcome
Title Percent Change From Baseline in Inflammatory Lesion Counts at Week 12
Hide Description 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).
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Per-Protocol Population consists of all randomized participants who completed the study to week 12 without any major protocol violation.
Arm/Group Title Aczone® Gel 5% Plus Differin® 0.3% Gel Duac® Topical Gel Plus Differin® 0.3% Gel
Hide Arm/Group Description:
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
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 Number of Participants Analyzed 122 118
Median (Full Range)
Unit of Measure: Percent change
-70.7
(-100.0 to 38.1)
-75.9
(-100.0 to -17.4)
5.Secondary Outcome
Title Percent Change From Baseline in Non-inflammatory Lesion Counts at Week 12
Hide Description 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).
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Per-Protocol Population consists of all randomized participants who completed the study to week 12 without any major protocol violation.
Arm/Group Title Aczone® Gel 5% Plus Differin® 0.3% Gel Duac® Topical Gel Plus Differin® 0.3% Gel
Hide Arm/Group Description:
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
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 Number of Participants Analyzed 122 118
Median (Full Range)
Unit of Measure: Percent change
-55.3
(-100.0 to 115.0)
-60.7
(-100.0 to 31.6)
6.Secondary Outcome
Title Percent Change From Baseline in Total Lesion Count at Week 12
Hide Description 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).
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Per-Protocol Population consists of all randomized participants who completed the study to week 12 without any major protocol violation.
Arm/Group Title Aczone® Gel 5% Plus Differin® 0.3% Gel Duac® Topical Gel Plus Differin® 0.3% Gel
Hide Arm/Group Description:
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
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 Number of Participants Analyzed 122 118
Median (Full Range)
Unit of Measure: Percent change
-62.7
(-98.0 to 75.6)
-65.0
(-100.0 to 8.5)
7.Secondary Outcome
Title Percentage of Participants Demonstrating a ≥ 1 Category Increase in Tolerability From Baseline at Week 12
Hide Description 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.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Per-Protocol Population consists of all randomized participants who completed the study to week 12 without any major protocol violation.
Arm/Group Title Aczone® Gel 5% Plus Differin® 0.3% Gel Duac® Topical Gel Plus Differin® 0.3% Gel
Hide Arm/Group Description:
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
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 Number of Participants Analyzed 122 118
Measure Type: Number
Unit of Measure: Percentage of participants
Dryness 21.3 11.9
Peeling 11.5 9.3
Oiliness 6.7 6.0
Erythema 8.2 6.8
Pruritus 12.4 8.5
Burning 13.2 12.7
Time Frame [Not Specified]
Adverse Event Reporting Description Safety population includes all participants who received study treatment.
 
Arm/Group Title Aczone® Gel 5% Plus Differin® 0.3% Gel Duac® Topical Gel Plus Differin® 0.3% Gel
Hide Arm/Group Description 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 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.
All-Cause Mortality
Aczone® Gel 5% Plus Differin® 0.3% Gel Duac® Topical Gel Plus Differin® 0.3% Gel
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Aczone® Gel 5% Plus Differin® 0.3% Gel Duac® Topical Gel Plus Differin® 0.3% Gel
Affected / at Risk (%) Affected / at Risk (%)
Total   0/136 (0.00%)   0/135 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Aczone® Gel 5% Plus Differin® 0.3% Gel Duac® Topical Gel Plus Differin® 0.3% Gel
Affected / at Risk (%) Affected / at Risk (%)
Total   23/136 (16.91%)   15/135 (11.11%) 
Infections and infestations     
Nasopharyngitis  1  15/136 (11.03%)  7/135 (5.19%) 
Nervous system disorders     
Headache * 1  8/136 (5.88%)  8/135 (5.93%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA v13.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Vice President Medical Affairs,
Organization: Allergan, Inc
Phone: 714-246-4500
EMail: clinicaltrials@allergan.com
Layout table for additonal information
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01231334     History of Changes
Other Study ID Numbers: MA-ACZ1001
First Submitted: October 28, 2010
First Posted: November 1, 2010
Results First Submitted: June 25, 2012
Results First Posted: July 27, 2012
Last Update Posted: July 27, 2012