Long-term Study of Efficacy/Safety of Adapalene/Benzoyl Peroxide Topical Gel in Acne Vulgaris Subjects

Study Overview
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Brief Summary
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This was a multi-center, open-label, non-comparative study that evaluated the long-term safety and efficacy profile of Adapalene/Benzoyl Peroxide Gel. Subjects were evaluated at Baseline, Weeks 1 and 2, and Months 1, 2, 4, 6, 8, 10, and 12. Safety was evaluated by spontaneous reports of Adverse Events (AEs), the Local Tolerability Assessment (Erythema, Scaling, Dryness, and Stinging/Burning), routine laboratory testing (hematology, blood chemistry, and urinalysis), and monitoring of suspected sensitizations. Efficacy was evaluated by analysis of Percent Change from Baseline in Inflammatory, Noninflammatory, and Total Lesion Counts, and by the Subject's Assessment of Acne.

Official Title
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A Long-term Safety and Efficacy Study of a Fixed Combination of Adapalene 0.1% and Benzoyl Peroxide 2.5% (Adapalene and Benzoyl Peroxide Topical Gel) Gel in Subjects With Acne Vulgaris

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Drug: Adapalene/Benzoyl Peroxide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A clinical diagnosis of acne vulgaris with facial involvement. A minimum of 20 but not more than 50 Inflammatory lesions. A minimum of 30 but not more than 100 Noninflammatory lesions. Exclusion Criteria: Subjects with presence of nodules or cysts. Acne conglobate, acne fulminans, secondary acne, or severe acne. Underlying diseases that required the use of interfering topical or systemic therapy. Use of prohibited medications prior to the study unless appropriate washout period was documented.

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adapalene/Benzoyl Peroxide<br>Participants were treated with adapalene 0.1 percent (%) [weight by weight (W/W)] and benzoyl peroxide 2.5 percent (%) (W/W) gel topically to the face and trunk area once daily in the evening. | Drug: Adapalene/Benzoyl Peroxide<br>* Adapalene 0.1 percent (%) [weight by weight (W/W)] and benzoyl peroxide 2.5 % (W/W) gel topically daily in the evening.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change From Baseline in Inflammatory, Noninflammatory and Total Lesion Count at Month 12 LOCF | Percent change in inflammatory, noninflammatory and total lesions at Month 12 was measured from baseline lesions. The noninflammatory lesion count was the sum of open comedones (a mass of sebaceous material that is impacted behind an open follicular orifice (blackhead) and closed comedones (a mass of sebaceous material that is impacted behind a closed follicular orifice (whitehead). The inflammatory lesion count was the sum of papules (a small, solid elevation less than 1.0 cm in diameter) and pustules (a small, circumscribed elevation of the skin that contains yellow-white exudate). The total lesion count was the sum of inflammatory and noninflammatory lesions. Missing adapalene and benzoyl peroxide data were imputed using last observation carried forward (LOCF). | Baseline, Month 12 LOCF | 
| Number of Participants Categorized Based on Participant's Assessment Scale of Acne at Month 6 | Participant's assessment of acne improvement was graded as 0; complete improvement, 1; marked improvement, 2; moderate improvement, 3; minimal improvement, 4; no change, 5; worse. | At Month 6 | 
| Number of Participants Categorized Based on Participant's Assessment Scale of Acne at Month 12 | Participant's assessment of acne improvement was graded as 0; complete improvement, 1; marked improvement, 2; moderate improvement, 3; minimal improvement, 4; no change, 5; worse. | At Month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Local Tolerability Assessment For Erythema | Local tolerability assessment for erythema (abnormal redness of the skin) was graded on a 0 (none) to 3 (severe) scale as follows; none (0- no erythema), mild (1- slight pinkness present), moderate (2- definite redness, easily recognized), severe (3- intense redness). The worst severity scores were generally mild or moderate, and rarely severe. | Baseline, Weeks 1 and 2, Months 1, 2, 4, 6, 8, 10 and 12 | 
| Number of Participants With Local Tolerability Assessment For Scaling | Local tolerability assessment for scaling (abnormal shedding of the stratum corneum) was graded on a 0 (none) to 3 (severe) scale as follow; none (0- no Scaling), mild (1- barely perceptible shedding, noticeable only on light scratching or rubbing), moderate (2- obvious but not profuse shedding), severe (3- heavy scale production). | Baseline, Weeks 1 and 2, Months 1, 2, 4, 6, 8, 10 and 12 | 
| Number of Participants With Local Tolerability Assessment For Dryness | Local tolerability assessment for dryness (brittle and/or tight sensation) was graded on a 0 (none) to 3 (severe) scale as follows; none (0- no dryness), mild (1- slight but definite roughness), moderate (2 -moderate roughness), severe (3- marked roughness). | Baseline, Weeks 1 and 2, Months 1, 2, 4, 6, 8, 10 and 12 | 
| Number of Participants With Local Tolerability Assessment For Stinging/Burning | Local tolerability assessment for stinging/burning [prickling pain sensation immediately after (within 5 minutes of) dosing] was graded on a 0 (none) to 3 (severe) scale as follows; none (0- no stinging/ burning), mild (1- slight warm, tingling/stinging sensation; not really bothersome), moderate (2- definite warm, tingling/stinging sensation that is somewhat), severe (3- hot, tingling/stinging sensation that has caused definite discomfort). | Baseline, Weeks 1 and 2, Months 1, 2, 4, 6, 8, 10 and 12 | 
| Number of Participant With Adverse Event (AE) and Serious Adverse Event (SAE) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | Baseline up to Month 14 | 
| Number of Participants With Clinically Significant Abnormal Laboratory Parameters | Clinical laboratory parameters included hematology, blood chemistry, urinalysis. Number of participants with clinically significant abnormalities in laboratory parameters which were deemed clinically significant by the investigator were reported. | Baseline up to Month 14 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acne Vulgaris, Adapalene, Benzoyl Peroxide