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Effect of Samples on Acne Treatment With Epiduo® Gel

This study has been completed.
Sponsor:
Collaborator:
Galderma Laboratories, L.P.
Information provided by (Responsible Party):
Steven R. Feldman, Wake Forest University Health Sciences
ClinicalTrials.gov Identifier:
NCT01504204
First received: December 28, 2011
Last updated: April 17, 2017
Last verified: April 2017
  Purpose
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 Intervention Phase
Acne Vulgaris Drug: Adapalene + benzoyl peroxide samples Drug: Adapalene + benzoyl peroxide from standard tube Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Steven R. Feldman, Wake Forest University Health Sciences:

Primary Outcome Measures:
  • 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:
  • 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.

  • 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


Enrollment: 20
Study Start Date: December 2011
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01504204

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: Steven R. Feldman, Professor of Dermatology, Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT01504204     History of Changes
Other Study ID Numbers: 15374
Study First Received: December 28, 2011
Last Updated: April 17, 2017
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 Steven R. Feldman, Wake Forest University Health Sciences:
adherence
adapalene
benzoyl peroxide
sample
topical treatment

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Benzoyl Peroxide
Adapalene
Adapalene, Benzoyl Peroxide Drug Combination
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

ClinicalTrials.gov processed this record on August 17, 2017