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 |
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.
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
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