Effect of Samples on Acne Treatment With Epiduo® Gel

NCT01504204 | Completed Phase 4 Results FDA Drug

• 1 other identifier: IRB00015374
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Acne Vulgaris

Keywords

adherence; adapalene; benzoyl peroxide; sample; topical treatment

Outcome Measures

Primary Outcomes (1)

• Adherence to Study Medication

  Adherence will be reported as percentage of prescribed doses taken as measured electronically by a Medication Event Monitoring System (MEMS®) cap.

  Baseline to 6 weeks

Secondary Outcomes (2)

• Change in Acne Global Assessment

  Baseline and 6 weeks

• Change in Acne Lesion Count

  Baseline and 6 weeks

Study Arms (2)

Medication with sample and demonstration

EXPERIMENTAL

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; Drug: Adapalene + benzoyl peroxide from standard tube

Medication without samples

ACTIVE COMPARATOR

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

Interventions

Adapalene + benzoyl peroxide samples 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.

Also known as: Epiduo

Medication with sample and demonstration

Adapalene + benzoyl peroxide from standard tube DRUG

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

Also known as: Epiduo

Medication with sample and demonstration; Medication without samples

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wake Forest University: lead
• Galderma R&D: collaborator

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27104, United States

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Adapalene; Adapalene, Benzoyl Peroxide Drug Combination

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Benzoyl Peroxide; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Drug Combinations; Pharmaceutical Preparations

Limitations and Caveats

This small pilot study subgroup analyses was limited.

Results Point of Contact

• Title: Irma M Richardsom, MHA
• Organization: Wake Forest University Health Sciences

irichard@wakehealth.edu

336-716-2903

Study Officials

• Steven R Feldman, MD, PhD

  Wake Forest University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2011
• First Posted: January 5, 2012
• Study Start: December 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: September 12, 2018
• Results First Posted: January 23, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)