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

Completed · Phase 3 · Has a placebo group

Conditions studied: Acne Vulgaris

In brief

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.

Key facts

Study ID

NCT03522441

Run by

Akorn, Inc.

People needed

1125

Starts

2018-04-27

Expected to finish

2019-04-22

Last updated by the study team

2020-10-05

Who can join

Age: 12 and older, up to 40. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• 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.

Where it is running

• Site 11 — Encino, California, United States
• Site 10 — Sherman Oaks, California, United States
• Site 1 — Brandon, Florida, United States
• Site 4 — Miramar, Florida, United States
• Site 5 — Miramar, Florida, United States
• Site 2 — Tampa, Florida, United States
• Site 3 — Tampa, Florida, United States
• Site 12 — High Point, North Carolina, United States
• Site 8 — El Paso, Texas, United States
• Site 9 — El Paso, Texas, United States
• Site 6 — Belize City, Belize
• Site 7 — Belize City, Belize

Full record on ClinicalTrials.gov

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