Effect of Samples on Acne Treatment With Epiduo® Gel

• ClinicalTrials.gov Identifier: NCT01504204
• Recruitment Status: Completed
• First Posted: January 5, 2012
• Results First Posted: January 23, 2018
• Last Update Posted: September 12, 2018
• Sponsor: Wake Forest University
• Collaborator: Galderma Laboratories, L.P.
• Information provided by (Responsible Party): Wake Forest University Health Sciences ( Wake Forest University )

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Acne Vulgaris	Drug: Adapalene + benzoyl peroxide samples; Drug: Adapalene + benzoyl peroxide from standard tube	Phase 4

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Effect of Sample Medication Use and Application Instructions on Adherence to and Efficacy of Treatment of Patients With Mild to Moderate Acne With Epiduo(R) Gel
• Study Start Date: December 2011
• Actual Primary Completion Date: November 2012
• Actual Study Completion Date: November 2012

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Drug: 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.; Other Name: Epiduo; 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.; Other Name: Epiduo
Active Comparator: Medication without samples; Subjects will receive the Adapalene + benzoyl peroxide from standard tube without a sample or demonstration of proper use of the medication.	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.; Other Name: Epiduo

Outcome Measures

Primary Outcome Measures :

1. Adherence to Study Medication [ Time Frame: Baseline to 6 weeks ]
   Adherence will be reported as percentage of prescribed doses taken as measured electronically by a Medication Event Monitoring System (MEMS®) cap.

Secondary Outcome Measures :

1. Change in Acne Global Assessment [ Time Frame: Baseline and 6 weeks ]
   Change in the physician's global assessment of acne severity on a validated 0-5 scale (0=clear to 5=very severe) from baseline to Week 6 visit.
2. Change in Acne Lesion Count [ Time Frame: Baseline and 6 weeks ]
   Change in total count of acne lesions from baseline visit to Week 6 visit

Eligibility Criteria

• Ages Eligible for Study: 12 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, North Carolina

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States, 27104

Sponsors and Collaborators

Wake Forest University

Galderma Laboratories, L.P.

Investigators

• Principal Investigator: Steven R Feldman, MD, PhD; Wake Forest University

More Information

• Responsible Party: Wake Forest University
• ClinicalTrials.gov Identifier: NCT01504204
• Other Study ID Numbers: IRB00015374
• First Posted: January 5, 2012
• Results First Posted: January 23, 2018
• Last Update Posted: September 12, 2018
• Last Verified: August 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Wake Forest University Health Sciences ( Wake Forest University ):

adherence; adapalene; benzoyl peroxide; sample; topical treatment

Additional relevant MeSH terms:

Acne Vulgaris; Acneiform Eruptions; Skin Diseases; Sebaceous Gland Diseases; Adapalene; Adapalene, Benzoyl Peroxide Drug Combination; Benzoyl Peroxide; Dermatologic Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antirheumatic Agents