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

Taro Pharmaceuticals USA1 site in 1 country550 target enrollmentSeptember 9, 2019

ConditionsAcne Vulgaris

InterventionsClindamycin Phosphate Clindamycin Phosphate RLD Placebos

DrugsClindamycin Phosphate Clindamycin Phosphate RLD Placebos

Overview

Phase: Phase 1
Intervention: Clindamycin Phosphate
Conditions: Acne Vulgaris
Sponsor: Taro Pharmaceuticals USA
Enrollment: 550
Locations: 1
Primary Endpoint: Demonstration of Bioequivalence
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Detailed Description

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

Registry

clinicaltrials.gov

Start Date

September 9, 2019

End Date

March 6, 2020

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Taro Pharmaceuticals USA

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy male or non pregnant female aged ≥ 12 and ≤ 40years 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 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 history of hypersensitivity or allergy to adapalene, retinoids and/or any of the study medication ingredients, have a known hypersensitivity to adapalene and benzoyl peroxide and its excitements.