Bioequivalence Study of Clindamycin Gel 1% in Treatment of Acne Vulgaris
Overview
This is a randomized, double-blind, multiple-site, placebo-controlled, parallel-group study, designed to compare the efficacy and safety of generic Clindamycin 1% gel (Akorn), and the marketed product Clindamycin 1% gel (Greenstone LLC) in the treatment of acne vulgaris.
Full Title of Study: “A Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study Comparing Clindamycin 1% Gel To Clindamycin 1% Gel (Greenstone LLC) and Both Active Treatments to Vehicle Control in the Treatment of Acne Vulgaris”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Double (Participant, Investigator)
- Study Primary Completion Date: April 22, 2019
Interventions
- Drug: Clindamycin 1% Gel
- Topical gel
- Drug: Placebo
- Topical Placebo gel
Arms, Groups and Cohorts
- Experimental: Clindamycin 1% gel (Akorn Pharmaceuticals)
- Active Comparator: Clindamycin 1% gel (Greenstone LLC)
- Placebo Comparator: Placebo
Clinical Trial Outcome Measures
Primary Measures
- Percent Change in the Number of Inflamed Lesions (Papules/Pustules)- Time Frame: Baseline to 12 Weeks
- Time Frame: Percent change from baseline to 12 weeks
- Percent Change in the Non-inflammatory (Open and Closed Comedones) Lesion Counts – Change in Baseline to 12 Week
- Time Frame: Percent change in baseline to 12 weeks
Participating in This Clinical Trial
IInclusion Criteria:
- Male or non-pregnant, non-lactating female, ≥12 and ≤40 years of age with a clinical diagnosis of acne vulgaris. – Have facial acne with: ≥20 facial inflammatory lesions (papules and pustules) and ≥25 non-inflammatory lesions (open and closed comedones), and ≤2 nodulocystic lesions (nodules and cysts) and have an IGA score of 2, 3 or 4. Exclusion Criteria:
- 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 active cystic acne. – Subject has acne conglobata. – Subjects with excessive facial hair such as beards, sideburns, moustaches, etc. that would interfere with the diagnosis or assessment of acne.
Gender Eligibility: All
Minimum Age: 12 Years
Maximum Age: 40 Years
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Akorn, Inc.
- Provider of Information About this Clinical Study
- Sponsor
Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.