Effect of Samples on Acne Treatment With Epiduo® Gel
This study has been completed.
Sponsor:
Wake Forest University
Collaborator:
Galderma Laboratories, L.P.
Information provided by (Responsible Party):
Steven R. Feldman, Wake Forest University
ClinicalTrials.gov Identifier:
NCT01504204
First received: December 28, 2011
Last updated: December 7, 2012
Last verified: December 2012
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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 |
|---|---|
|
Acne Vulgaris |
Drug: Adapalene + benzoyl peroxide samples Drug: Adapalene + benzoyl peroxide from standard tube |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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 Wake Forest University:
Primary Outcome Measures:
- Adherence to Study Medication [ Time Frame: Baseline to 6 weeks ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 medication 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 medication in a 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
|
Eligibility| Ages Eligible for Study: | 12 Years and older |
| Genders Eligible for Study: | Both |
| 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
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
No publications provided
| Responsible Party: | Steven R. Feldman, Professor of Dermatology, Wake Forest University |
| ClinicalTrials.gov Identifier: | NCT01504204 History of Changes |
| Other Study ID Numbers: | 15374 |
| Study First Received: | December 28, 2011 |
| Last Updated: | December 7, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Wake Forest University:
|
adherence adapalene benzoyl peroxide sample topical treatment |
Additional relevant MeSH terms:
|
Acne Vulgaris Acneiform Eruptions Skin Diseases Facial Dermatoses Sebaceous Gland Diseases Adapalene Benzoyl Peroxide Dermatologic Agents Therapeutic Uses Pharmacologic Actions |
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 Central Nervous System Agents |
ClinicalTrials.gov processed this record on June 18, 2013