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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-27

Study Completion Date

2019-04-22

Brief Summary

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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.

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Detailed Description

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Conditions

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Acne Vulgaris

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Clindamycin 1% gel (Akorn Pharmaceuticals)

Group Type EXPERIMENTAL

Clindamycin 1% Gel

Intervention Type DRUG

Topical gel

Clindamycin 1% gel (Greenstone LLC)

Group Type ACTIVE_COMPARATOR

Clindamycin 1% Gel

Intervention Type DRUG

Topical gel

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Topical Placebo gel

Interventions

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Clindamycin 1% Gel

Topical gel

Intervention Type DRUG

Placebo

Topical Placebo gel

Intervention Type DRUG

Eligibility Criteria

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Inclusion 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.

Minimum Eligible Age

12 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No