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

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