Bioequivalence Study of Clindamycin Phosphate Topical Lotion, 1% in Subjects With Acne Vulgaris



Status:Recruiting
Conditions:Acne, Acne, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:12 - 40
Updated:11/24/2018
Start Date:October 3, 2018
End Date:October 2019
Contact:Oleg Khatsenko
Email:ClinicalResearch@therapeuticsinc.com
Phone:858-571-1800

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A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Comparison Study to Determine the Therapeutic Equivalence of GDC 268 and Clindamycin Phosphate Topical Lotion, 1% in Subjects With Acne Vulgaris

The objective of the study is to evaluate the safety, tolerability, and therapeutic
equivalence of GDC 268 to Clindamycin Phosphate Topical Lotion, 1% and to compare the
efficacy of these two products to the GDC vehicle lotion (i.e., placebo) in the treatment of
acne vulgaris.


Inclusion Criteria:

- Male or non-pregnant, non-lactating female, ≥12 and ≤40 years of age with a clinical
diagnosis of acne vulgaris.

- Must have ≥ 25 but ≤ 100 non-inflammatory lesions (open and closed comedones) AND ≥ 20
but ≤ 70 inflammatory lesions (papules and pustules) AND ≤ 2 nodulocystic lesions
(nodules and cysts) on the face (e.g., forehead, nose, cheeks, chin, upper lip) at
Baseline.

- Must be willing and able to refrain from use of all other topical products in the
treatment area, all acne medications other than test article, and all antibiotics
(other than test article) during the 12-week treatment period.

- Women must be surgically sterile, or use an effective method of birth control with a
negative urine pregnancy test (UPT) at the Baseline Visit (Day 1).

- In good general health and free of any other clinically significant disease state or
physical condition.

- Subject has provided written informed consent / assent.

Exclusion Criteria:

- Subject is pregnant, breastfeeding, or is planning to become pregnant or breastfeed
during the study.

- 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 excessive facial hair (e.g., beards, sideburns, moustaches), facial
tattoos, or other facial attributes that would interfere with diagnosis or assessment
of acne vulgaris in the opinion of the investigator.

- Subject is planning surgery during the study.

- Subject has a history of hypersensitivity or allergy to clindamycin or lincomycin
and/or any of the ingredients in the test articles.

Other Eligibility Criteria not listed above will be reviewed for each prospective subject
by the study staff.
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Rogers, Arkansas 72758
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DeLand, Florida 32720
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