Bio-equivalence Study With Clinical Endpoints in the Treatment of Acne Vulgaris

A Randomized, Double-Blind, Multiple Center Placebo Controlled Study Comparing Taro Product to RLD and Both Treatments to a Placebo Control in the Treatment of Acne Vulgaris.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04134273

Enrollment

1260

Registered

2019-10-22

Start date

2019-03-20

Completion date

2019-10-15

Last updated

2019-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acne Vulgaris

Brief summary

This study is to evaluate the therapeutic equivalence and safety of Taro Product to RLD in the treatment of acne vulgaris.

Detailed description

The study objectives are to evaluate the therapeutic equivalence and safety of Taro Product to RLD in the treatment of acne vulgaris and to demonstrate the superiority of the efficacy of the test and reference products over the placebo control.

Interventions

DRUGCLPG Topical Gel 1%

Clindamycin Phosphate Topical Gel 1% (Taro Pharmaceuticals U.S.A, Inc.)

DRUGClindamycin

Clindamycin Phosphate topical gel 1%

DRUGPlacebo

Placebo (vehicle of the test product) (Taro Pharmaceuticals Inc.)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

12 Years to 40 Years

Healthy volunteers

Inclusion criteria

* Healthy male or non-pregnant female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of acne vulgaris * Subjects who are 18 years of age or older (up to the age of 40) must have provided IRB approved written informed consent. Subjects 12 to 17 years of age, inclusive, must have provided IRB approved written assent; this written assent must be accompanied by an IRB approved written informed consent from the Subject's legally acceptable representative (i.e., parent or guardian). * Subjects must have a definite clinical diagnosis of acne vulgaris severity grade 2, 3, or 4 as per the Investigator's Global Assessment (IGA).

Exclusion criteria

* Female Subjects who are pregnant, nursing or planning to become pregnant during study participation. * Subjects with a known hypersensitivity to clindamycin or lincomycin and/or any ingredients in the study drugs. * Subjects with the presence of any skin condition that would interfere with the diagnosis or assessment of acne vulgaris (e.g., on the face: rosacea, dermatitis, psoriasis, squamous cell carcinoma, eczema, acneiform eruptions caused by medications, steroid acne, steroid folliculitis, or bacterial folliculitis).

Design outcomes

Primary

Measure	Time frame	Description
Demonstration of Bioequivalence	Week 12	Demonstration of Bioequivalence in percent change in inflammatory and non-inflammatory lesion counts.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026