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

Akorn

Status and phase: Completed; Phase 3

Conditions: Acne Vulgaris

Treatments: Drug: Clindamycin 1% Gel; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03522441

CLMG 1711

Details and patient eligibility

About

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.

Enrollment: 1,125 patients

Sex: All

Ages: 12 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

1,125 participants in 3 patient groups, including a placebo group

Clindamycin 1% gel (Akorn Pharmaceuticals)

Experimental group

Treatment:

Drug: Clindamycin 1% Gel

Clindamycin 1% gel (Greenstone LLC)

Active Comparator group

Treatment:

Drug: Clindamycin 1% Gel

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo