Study Comparing Adapalene Gel 0.3% to Differin® 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 Gel 0.3% to Differin® (Adapalene Gel 0.3%) and Both Active Treatments to a Placebo Control in the Treatment of Acne Vulgaris

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02411942
• Other study ID #: ADPG 1410
• Status: Completed
• Phase: Phase 1
• First received: April 4, 2015
• Last updated: May 3, 2017
• Start date: August 2014
• Est. completion date: February 2015

Study information

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

Clinical Trial Summary

The objectives of this study are to evaluate the therapeutic equivalence and safety of Adapalene Gel 0.3% and Differin® (adapalene gel 0.3%).

Description:

The objectives of this study are to evaluate the therapeutic equivalence and safety of Adapalene Gel 0.3% and Differin® (adapalene gel 0.3%) in the treatment of acne vulgaris and to demonstrate the superiority of the efficacy of the test and reference products over the placebo.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 753
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• 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 aged 18 years and older must have provided written consent. Subjects aged 12 to 17 years must have provided written assent accompanied by written consent from their legally acceptable representative. All subjects or their legally acceptable representatives must sign Health Insurance Portability and Accountability Act authorization.

• Must have a minimum of = 25 non-inflammatory lesions and = 20 inflammatory lesions and = 2 nodulocystic lesions at baseline on the face.

• Must have a definite clinical diagnosis of acne vulgaris severity grade 2, 3, or 4 as per the Investigator's Global Assessment.

Exclusion Criteria:

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

• Have a history of hypersensitivity or allergy to adapalene, retinoids and/or any of the study medication ingredients.

• Presence of any skin condition that would interfere with the diagnosis or assessment of acne vulgaris.

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• Adapalene Gel 0.3%
Adapalene Gel 0.3% applied to the entire face once daily for 84 consecutive days
• Differin®
Differin® applied to the entire face once daily for 84 consecutive days
• Placebo
Placebo (vehicle of the test product) applied to the entire face once daily for 84 consecutive days

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