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

Balmoral Medical

Status and phase: Completed; Phase 3

Conditions: Acne Vulgaris

Treatments: Drug: Clindamycin Phosphate Lotion 1%; Drug: GDC Vehicle Lotion; Drug: GDC 268 Lotion

Study type: Interventional

Funder types: Industry

Identifiers

NCT03717506

GDC-268-001

Details and patient eligibility

About

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.

Enrollment: 1,236 patients

Sex: All

Ages: 12 to 40 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,236 participants in 3 patient groups, including a placebo group

Test product

Experimental group

Description:

GDC 268 Lotion applied topically as directed.

Treatment:

Drug: GDC 268 Lotion

Reference Product

Active Comparator group

Description:

Clindamycin Phosphate Lotion, 1% applied topically as directed.

Treatment:

Drug: Clindamycin Phosphate Lotion 1%

Placebo

Placebo Comparator group

Description:

GDC Vehicle lotion applied topically as directed.

Treatment:

Drug: GDC Vehicle Lotion