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

Completed · Phase 3 · Has a placebo group

Conditions studied: Acne Vulgaris

In brief

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.

Key facts

Study ID

NCT03717506

Run by

Balmoral Medical company

People needed

1236

Starts

2018-10-10

Expected to finish

2020-04-16

Last updated by the study team

2021-05-04

Who can join

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

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Site 07 — Fort Smith, Arkansas, United States
• Site 22 — Rogers, Arkansas, United States
• Site 25 — Fountain Valley, California, United States
• Site 33 — Northridge, California, United States
• Site 30 — San Diego, California, United States
• Site 44 — Aventura, Florida, United States
• Site 36 — Brandon, Florida, United States
• Site 45 — DeLand, Florida, United States
• Site 41 — Largo, Florida, United States
• Site 38 — Miami, Florida, United States
• Site 35 — Miami Lakes, Florida, United States
• Site 37 — North Miami Beach, Florida, United States
• Site 26 — St. Petersburg, Florida, United States
• Site 42 — Tampa, Florida, United States
• Site 01 — West Palm Beach, Florida, United States
• Site 10 — Newnan, Georgia, United States
• Site 09 — Boise, Idaho, United States
• Site 05 — Rolling Meadows, Illinois, United States
• Site 02 — Plainfield, Indiana, United States
• Site 27 — Overland Park, Kansas, United States
• Site 28 — Clarkston, Michigan, United States
• Site 24 — Fridley, Minnesota, United States
• Site 49 — Omaha, Nebraska, United States
• Site 06 — High Point, North Carolina, United States
• Site 32 — Raleigh, North Carolina, United States

Full record on ClinicalTrials.gov

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