A Clinical Trial to Evaluate the Efficacy of Two Acne Treatments

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy of 2 acne treatments for 24 weeks of use in adult men and women with mild to moderate facial acne, at least 5 inflammatory lesions, and at least 10 - 100 non-inflammatory lesions.

Detailed Description
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To characterize the effectiveness of the acne treatment in lesion count at week 1, week 2, week 6, week 12, and week 24 as compared to baseline and compare between treatments To characterize the effectiveness of the acne treatment in Investigator's Global Improvement Assessment at week 1, week 2, week 6, week 12, and week 24 as compared to baseline and compare between treatments To characterize the effect of the acne treatment in clinical grading of efficacy parameters through digital images at week 6, week 12, and week 24 as compared to baseline and compare between treatments To characterize the effect of the acne treatment in subject self-assessment questionnaire responses at week 1, week 2, week 6, week 12, and week 24 as compared to baseline and compare between treatments

Official Title
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A Multi-Center Clinical Trial to Evaluate the Efficacy of Two Acne Treatments

Conditions
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Acne

Intervention / Treatment
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* Drug: Product A
* Drug: Product B


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Men and women age 21 to 45 years at the time of enrollment. Individuals with mild to moderate acne (score of 2-3 on FDA Investigator's Global Assessment Scale1) on the face. Individuals with at least 5 inflammatory lesions. Individuals with 10 - 100 non-inflammatory lesions. Fitzpatrick skin type I-VI Individuals willing to provide written informed consent including photo release, Health Insurance Portability and Accountability Act (HIPAA), and are able to read, speak,write, understand English. Willing to withhold all facial treatments during the course of the study Individuals of child bearing potential who use an acceptable method of contraception throughout the study. Subjects must be stable on any medication they are taking for at least 30 days. Key Exclusion Criteria: Individuals diagnosed with allergies to topical acne products. Individuals having a condition and/or disease of the skin that the Investigator deems inappropriate for participation. Women who are nursing, pregnant, or planning to become pregnant during the study. Individuals who have pre-existing or dormant dermatologic conditions on the face which in the opinion of the Investigator could interfere with the outcome of the study. Individuals using or who have used any systemic medication considered to affect the course of acne, specifically, but not exclusively antibiotics or steroids within the last 30 days prior to entry into the study. Individuals who are currently participating in another facial usage study or have participated in a clinical trial within 4 weeks prior to inclusion into the study. Individuals with any planned surgeries and/or invasive medical procedures during the course of the study. Individuals who started hormone replacement therapies (HRT) or hormones for birth control less than 3 months prior to study entry or who plan on starting, stopping, or changing doses of HRT or hormones for birth control during the study. Individuals with facial sunburn or excessive tanned facial skin or that are not willing to avoid daily sun exposure on the face and the use of tanning beds or sunless tanning products for the duration of the study. Individuals that are currently taking or have taken within the last 30 days oral or topical prescription medications for acne.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Product A (adapalene)<br>Product A applied topically to the entire face or other affected area of the skin once daily | Drug: Product A<br>* Product A applied topically to the entire face or other affected area of the skin once daily<br>* Other names: Adapalene;|
| Active Comparator: Product B (salicylic acid)<br>Product B applied topically to the affected area of the skin 1 to 3 times daily. | Drug: Product B<br>* Product B applied topically to affected area of the skin 1 to 3 times daily<br>* Other names: Salicylic acid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change From Baseline in Total Lesions at Week 12 | Percent change from baseline in total lesions at week 12 was assessed by investigator or designee. Investigator or designee counted and recorded the number of open comedones, closed comedones, papules, and pustules on each subject's face. Lesions were counted globally on the following facial locations/quadrants: forehead, left cheek, chin, and right cheek. Each of the following lesion types were analyzed separately for forehead, left cheek, chin, right cheek, and the total of the 4 areas: Inflammatory acne lesions (sum of papules and pustules) Non-inflammatory acne lesions (sum of open comedones and closed comedones) Total lesion counts (sum of inflammatory and non-inflammatory acne lesions counts) | Baseline and 12 weeks |