Bioequivalence Study of Clindamycin Phosphate Topical Lotion, 1% in Subjects With Acne Vulgaris

Study Overview
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Brief Summary
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The objective of the study is to evaluate the safety, tolerability, and therapeutic equivalence of GDC 268 to Clindamycin Phosphate Topical Lotion, 1% and to compare the efficacy of these two products to the GDC vehicle lotion (i.e., placebo) in the treatment of acne vulgaris.

Official Title
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A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Comparison Study to Determine the Therapeutic Equivalence of GDC 268 and Clindamycin Phosphate Topical Lotion, 1% in Subjects With Acne Vulgaris

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Drug: GDC 268 Lotion
* Drug: Clindamycin Phosphate Lotion 1%
* Drug: GDC Vehicle Lotion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or non-pregnant, non-lactating female, ≥12 and ≤40 years of age with a clinical diagnosis of acne vulgaris. Must have ≥ 25 but ≤ 100 non-inflammatory lesions (open and closed comedones) AND ≥ 20 but ≤ 70 inflammatory lesions (papules and pustules) AND ≤ 2 nodulocystic lesions (nodules and cysts) on the face (e.g., forehead, nose, cheeks, chin, upper lip) at Baseline. Must be willing and able to refrain from use of all other topical products in the treatment area, all acne medications other than test article, and all antibiotics (other than test article) during the 12-week treatment period. Women must be surgically sterile, or use an effective method of birth control with a negative urine pregnancy test (UPT) at the Baseline Visit (Day 1). In good general health and free of any other clinically significant disease state or physical condition. Subject has provided written informed consent / assent. Exclusion Criteria: Subject is pregnant, breastfeeding, or is planning to become pregnant or breastfeed during the study. Subject has more than 2 facial nodular lesions; any nodules present will be documented but not included in the inflammatory lesion count for analysis. Subject has excessive facial hair (e.g., beards, sideburns, moustaches), facial tattoos, or other facial attributes that would interfere with diagnosis or assessment of acne vulgaris in the opinion of the investigator. Subject is planning surgery during the study. Subject has a history of hypersensitivity or allergy to clindamycin or lincomycin and/or any of the ingredients in the test articles. Other Eligibility Criteria not listed above will be reviewed for each prospective subject by the study staff.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 40 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test product<br>GDC 268 Lotion applied topically as directed. | Drug: GDC 268 Lotion<br>* GDC 268 is a topical lotion<br>|
| Active Comparator: Reference Product<br>Clindamycin Phosphate Lotion, 1% applied topically as directed. | Drug: Clindamycin Phosphate Lotion 1%<br>* Clindamycin Phosphate Lotion is an FDA-approved drug product<br>|
| Placebo Comparator: Placebo<br>GDC Vehicle lotion applied topically as directed. | Drug: GDC Vehicle Lotion<br>* GDC Vehicle Lotion contains 0.0% of active drug and is matched to the other two active test drugs<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Percent Change in the Number of Inflamed Lesions | Percent Change from Baseline to Week 12 in inflammatory lesion counts (Papules/Pustules). | 12 weeks | 
| Mean Percent Change in the Non-inflammatory Lesion Counts | Percent Change (i.e., reduction) from Baseline to Week 12 in non-inflammatory (open and closed comedones) lesion counts. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Percentage of Subjects With a Clinical Response (IGA) of Success at Week 12 | Investigator's Global Assessment, IGA. Overall severity of acne was assessed using a five-point scale from 0=Clear to 4=Severe. Subjects must have had an IGA score of 2 (mild), 3 (moderate), or 4 (severe) at Baseline. Success is defined as an IGA score at week 12 that is at least 2 grades less than the baseline assessment. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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zits, pimples, blackheads