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NCT04321070 Clinical Trial

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 NCT04321070
Other study ID # CLPL 1907
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date September 9, 2019
Est. completion date March 6, 2020

Study information
Verified date March 2020
Source Taro Pharmaceuticals USA
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility
Status Completed
Enrollment 550
Est. completion date March 6, 2020
Est. primary completion date December 14, 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 = 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Clindamycin Phosphate
A thin film of investigation product will be applied to the affected areas of the face once daily
• Clindamycin Phosphate RLD
A thin film of investigation product will be applied to the affected areas of the face once daily
• Placebos
A thin film of investigation product will be applied to the affected areas of the face once daily

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
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