Effect of Samples on Acne Treatment With Epiduo® Gel

NCT ID: NCT01504204

Last Updated: 2018-09-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2012-11-30

Brief Summary

The purpose of this study is to compare adherence to treatment and efficacy with Epiduo® Gel in patients with mild to moderate acne who receive a medication sample and instructions on proper application with their stock size medication tube versus patients who receive only the stock size medication tube.

Detailed Description

Adapalene Topical Gel is a Vitamin A type product in a water-based gel that is applied to the skin. It is approved by the United States Food and Drug Administration (FDA) for the treatment of acne. Benzoyl Peroxide is a medication applied to the skin that is also approved by the FDA for the treatment of acne and has anti-bacterial properties.

The purpose of this study is to evaluate the safety and effectiveness of a drug called Epiduo® Gel 0.1%/2.5% for the treatment of acne vulgaris.Epiduo® is a combination of adapalene and benzoyl peroxide. This combination drug is approved by the FDA for sale in the United States for use in individuals with acne who are over the age of 12.

Conditions

Acne Vulgaris

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Medication with sample and demonstration

Subjects will receive a sample tube of the Adapalene + benzoyl peroxide samples with demonstration of how to use it at the first visit.

Group Type: EXPERIMENTAL

Adapalene + benzoyl peroxide samples

Intervention Type: DRUG

A sample size tube of the study medication, combination adapalene 0.1% plus benzoyl peroxide 2.5% gel, will be provided with instruction on proper application, including demonstration, at the first visit.

Adapalene + benzoyl peroxide from standard tube

Intervention Type: DRUG

Subjects are instructed to apply the combination adapalene 0.1% plus benzoyl peroxide 2.5% gel once daily to all affected areas.

Medication without samples

Subjects will receive the Adapalene + benzoyl peroxide from standard tube without a sample or demonstration of proper use of the medication.

Group Type: ACTIVE_COMPARATOR

Adapalene + benzoyl peroxide from standard tube

Intervention Type: DRUG

Subjects are instructed to apply the combination adapalene 0.1% plus benzoyl peroxide 2.5% gel once daily to all affected areas.

Interventions

Adapalene + benzoyl peroxide samples

A sample size tube of the study medication, combination adapalene 0.1% plus benzoyl peroxide 2.5% gel, will be provided with instruction on proper application, including demonstration, at the first visit.

Intervention Type: DRUG

Adapalene + benzoyl peroxide from standard tube

Subjects are instructed to apply the combination adapalene 0.1% plus benzoyl peroxide 2.5% gel once daily to all affected areas.

Intervention Type: DRUG

Other Intervention Names

Epiduo; Epiduo

Eligibility Criteria

Inclusion Criteria

• Male or female subject with mild to moderate acne, aged 12 and older, who agrees to participate and provides written consent.
• Have an Acne Global Assessment (AGA) of mild to moderate acne (an AGA score of 2 or 3)

Exclusion Criteria

• Presence of a concurrent medical condition or skin condition, which is determined by the investigator to potentially interfere with study outcomes or patient assessments.
• Subjects with known allergy or sensitivity to Epiduo® Gel (or Benzoyl Peroxide Gel) or components therein, including adapalene or benzoyl peroxide
• Female subjects who are not postmenopausal for at least 1 year, surgically sterile, or willing to practice effective contraception during the study. Reliable methods of birth control are: abstinence (not having sex), oral contraceptives, intrauterine device (IUD), Depo-Provera, tubal ligation, or vasectomy of the partner (with confirmed negative sperm counts) in a monogamous relationship (same partner). An acceptable, although less reliable, method involves the careful use of condoms and spermicidal foam or gel and/or a cervical cap or sponge. Nursing mothers, pregnant women and women planning to become pregnant while on study are to be excluded.

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Galderma R&D

INDUSTRY

Sponsor Role: collaborator

Wake Forest University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steven R Feldman, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University

Locations

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Countries

United States

Other Identifiers

IRB00015374

Identifier Type: -

Identifier Source: org_study_id