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



Status:Recruiting
Conditions:Acne, Acne, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:12 - 40
Updated:5/13/2018
Start Date:April 27, 2018
End Date:November 28, 2018
Contact:Robert E Adamczyk, PharmD
Email:rob.adamczyk@akorn.com
Phone:609.662.9100

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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

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.


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.
We found this trial at
8
sites
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mi
from
Miramar, FL
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Belize City,
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Brandon, FL
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El Paso, TX
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Encino, CA
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High Point, NC
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Sherman Oaks, CA
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Tampa, FL
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