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

Phase 1

Completed

• Conditions: Acne Vulgaris
• Interventions: Drug: Placebo; Drug: CLPG Topical Gel 1%; Drug: Clindamycin

• Registration Number: NCT04134273
• Lead Sponsor: Taro Pharmaceuticals USA

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.

Study Timeline

• Study Start: 2019-03-20
• Primary Completion: 2019-09-17
• Status Verified: 2019-10
• Study Completion: 2019-10-15
• Study First Submitted: 2019-10-18
• Study First Submitted QC: 2019-10-18
• Last Update Submitted: 2019-10-18
• Study First Posted: 2019-10-22
• Last Update Posted: 2019-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1260

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vehicle of the test product	Placebo	Placebo (vehicle of the test product), applied to the face twice a day for 84 days.
CLPG Topical Gel 1%	CLPG Topical Gel 1%	Clindamycin Phosphate Topical Gel 1%, applied to the face twice a day for 84 days.
Clindamycin Phosphate Topical Gel 1%	Clindamycin	Clindamycin Phosphate Topical Gel 1%, applied to the face twice a day for 84 days.

Primary Outcome Measures

Name	Time	Method
Demonstration of Bioequivalence	Week 12	Demonstration of Bioequivalence in percent change in inflammatory and non-inflammatory lesion counts.

Trial Locations

Locations (1)

Catawba Research, LLC; 🇺🇸 Charlotte, North Carolina, United States