Bioequivalence Study of Clindamycin Gel 1% in Treatment of Acne Vulgaris

• Status: Completed
• Trial end date: 2019-04-22
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Akorn, Inc.
• Collaborator: Catawba
• Treatments: Clindamycin; Clindamycin palmitate; Clindamycin phosphate

Criteria

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.