Study Comparing Adapalene/BP Gel to EPIDUO® FORTE and Both to a Placebo Control in Treatment of Acne Vulgaris

Acne Vulgaris Clinical Trial

Official title:

A Multi-center, Double-blind, Randomized, Placebo, Controlled, Parallel-group Study, Comparing Adapalene/BP Gel, 0.3%/2.5% to EPIDUO® FORTE GEL and Both Active Treatments to a Placebo Control in the Treatment of Acne Vulgaris

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02709902
• Other study ID #: ADBG 1519
• Status: Completed
• Phase: Phase 1
• First received: March 8, 2016
• Last updated: May 3, 2017
• Start date: September 2015
• Est. completion date: March 2016

Study information

• Verified date: May 2017
• Source: Taro Pharmaceuticals USA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Bioequivalence with Clinical Endpoints.

Description:

Randomized, Double-Blind, Placebo-Controlled, Multiple-Site, Parallel Design, Bioequivalence with Clinical Endpoints.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 460
• Est. completion date: March 2016
• Est. primary completion date: February 2016
• 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.

Exclusion Criteria:

• Female Subjects who are pregnant, nursing or planning to become pregnant during study participation

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• Adapalene/BP gel, 0.3%/2.5%
Gel
• EPIDUO® FORTE
Gel
• Placebo
Gel

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Taro Pharmaceuticals USA

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in inflammatory lesion counts	Percent change from baseline to week 12 in the inflammatory (papules and pustules) lesion counts	Week 12
Primary	Change in non-inflammatory lesion counts	Percent change from baseline to week 12 in the non-inflammatory (open and closed comedones) lesion counts	Week 12
Secondary	Clinical response of success	The proportion of subjects with a clinical response of success at week 12, success defined as an Investigator's Global Assessment score that is at least two grades less than the baseline assessment	Week 12