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

Acne Vulgaris Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04134273
• Other study ID #: CLPG 1809
• Status: Completed
• Phase: Phase 1
• Start date: March 20, 2019
• Est. completion date: October 15, 2019

Study information

• Verified date: October 2019
• Source: Taro Pharmaceuticals USA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1260
• Est. completion date: October 15, 2019
• Est. primary completion date: September 17, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 40 Years

Eligibility

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).

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• CLPG Topical Gel 1%
Clindamycin Phosphate Topical Gel 1% (Taro Pharmaceuticals U.S.A, Inc.)
• Clindamycin
Clindamycin Phosphate topical gel 1%
• Placebo
Placebo (vehicle of the test product) (Taro Pharmaceuticals Inc.)

Locations

Country	Name	City	State
United States	Catawba Research, LLC	Charlotte	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Taro Pharmaceuticals USA

Country where clinical trial is conducted

United States, 

Outcome

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