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Effect of Samples on Acne Treatment With Epiduo® Gel

Primary Purpose

Acne Vulgaris

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Adapalene + benzoyl peroxide samples
Adapalene + benzoyl peroxide from standard tube
Sponsored by
Wake Forest University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Vulgaris focused on measuring adherence, adapalene, benzoyl peroxide, sample, topical treatment

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Wake Forest University Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Medication with sample and demonstration

Medication without samples

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in Acne Global Assessment
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
Change in total count of acne lesions from baseline visit to Week 6 visit

Full Information

First Posted
December 28, 2011
Last Updated
August 13, 2018
Sponsor
Wake Forest University
Collaborators
Galderma R&D
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1. Study Identification

Unique Protocol Identification Number
NCT01504204
Brief Title
Effect of Samples on Acne Treatment With Epiduo® Gel
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 Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University
Collaborators
Galderma R&D

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris
Keywords
adherence, adapalene, benzoyl peroxide, sample, topical treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Medication with sample and demonstration
Arm Type
Experimental
Arm Description
Subjects will receive a sample tube of the Adapalene + benzoyl peroxide samples with demonstration of how to use it at the first visit.
Arm Title
Medication without samples
Arm Type
Active Comparator
Arm Description
Subjects will receive the Adapalene + benzoyl peroxide from standard tube without a sample or demonstration of proper use of the medication.
Intervention Type
Drug
Intervention Name(s)
Adapalene + benzoyl peroxide samples
Other Intervention Name(s)
Epiduo
Intervention Description
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
Intervention Name(s)
Adapalene + benzoyl peroxide from standard tube
Other Intervention Name(s)
Epiduo
Intervention Description
Subjects are instructed to apply the combination adapalene 0.1% plus benzoyl peroxide 2.5% gel once daily to all affected areas.
Primary Outcome Measure Information:
Title
Adherence to Study Medication
Description
Adherence will be reported as percentage of prescribed doses taken as measured electronically by a Medication Event Monitoring System (MEMS®) cap.
Time Frame
Baseline to 6 weeks
Secondary Outcome Measure Information:
Title
Change in Acne Global Assessment
Description
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.
Time Frame
Baseline and 6 weeks
Title
Change in Acne Lesion Count
Description
Change in total count of acne lesions from baseline visit to Week 6 visit
Time Frame
Baseline and 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven R Feldman, MD, PhD
Organizational Affiliation
Wake Forest University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effect of Samples on Acne Treatment With Epiduo® Gel

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