A Phase 4 interventional study of Adapalene + benzoyl peroxide samples and Adapalene + benzoyl peroxide from standard tube in Acne Vulgaris, sponsored by Wake Forest University. Completed at 1 site in United States. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2018-09-12.
Sponsored by Wake Forest University · Phase 4, Interventional, and Treatment
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.
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.
730 studies on the registry are indexed under Acne Vulgaris; 86 are open to participants now.
This study's enrollment of 20 is below the median of 69 across 628 interventional studies indexed under Acne Vulgaris.
Browse Acne Vulgaris studies →Wake Forest University is the lead sponsor of 116 studies on the registry; 7 are open to participants now.
Of its 31 completed or terminated interventional studies of FDA-regulated products, 27 (87%) have results posted.
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Exclusion Criteria:
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
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
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
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
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.
Time frame: Baseline to 6 weeks
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.
Time frame: Baseline and 6 weeks
Change in Acne Lesion Count
Change in total count of acne lesions from baseline visit to Week 6 visit
Time frame: Baseline and 6 weeks
Subjects were recruited from Wake Forest Baptist Medical Center Dermatology clinic and phone database of previously seen mild to moderate acne.
| Milestone | Medication With Sample and Demonstration | Medication Without Samples |
|---|---|---|
| Started | 10 | 10 |
| Completed | 9 | 9 |
| Not completed | 1 | 1 |
| Withdrew: Lost to follow-up | 1 | 1 |
Adherence will be reported as percentage of prescribed doses taken as measured electronically by a Medication Event Monitoring System (MEMS®) cap.
| percentage of doses | Medication With Sample and Demonstration | Medication Without Samples |
|---|---|---|
| Adherence to Study Medication | 86 ± 2.2 | 71 ± 0.34 |
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.
| Participants | Medication With Sample and Demonstration | Medication Without Samples |
|---|---|---|
| Baseline — AGA (2-mild) | 5 | 6 |
| Baseline — AGA (3 moderate) | 4 | 3 |
| Baseline — AGA (1 almost clear) | 0 | 0 |
| Week 6 — AGA (2-mild) | 3 | 4 |
| Week 6 — AGA (3 moderate) | 2 | 3 |
| Week 6 — AGA (1 almost clear) | 4 | 2 |
Change in total count of acne lesions from baseline visit to Week 6 visit
| lesions | Medication With Sample and Demonstration | Medication Without Samples |
|---|---|---|
| Basleine (Inflammatory Lesions) | 3 (0 to 10) | 2 (0 to 12) |
| Baseline (Non-Inflammatory) | 33 (16 to 57) | 38 (6 to 62) |
| Week 6 (inflammatory Lesion) | 1 (0 to 9) | 1 (0 to 14) |
| Week 6 (Non-inflammatory Lesion) | 19 (5 to 40) | 35 (4 to 53) |
Collected over One year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Medication With Sample and Demonstration | 0/10 (0%) | 0/10 (0%) | 6/10 (60%) |
| Medication Without Samples | 0/10 (0%) | 0/10 (0%) | 6/10 (60%) |
| Event | Medication With Sample and Demonstration | Medication Without Samples |
|---|---|---|
| DrynessSkin and subcutaneous tissue disorders | 3/10 | 3/10 |
| itchingSkin and subcutaneous tissue disorders | 3/10 | 2/10 |
| rednessSkin and subcutaneous tissue disorders | 0/10 | 1/10 |
| Age, Customized(years) | Medication With Sample and Demonstration | Medication Without Samples | Total |
|---|---|---|---|
| Age | 19 (13 to 31) | 19 (13 to 29) | 19 (13 to 31) |
| Sex: Female, Male(Participants) | Medication With Sample and Demonstration | Medication Without Samples | Total |
|---|---|---|---|
| Female | 8 | 6 | 14 |
| Male | 1 | 3 | 4 |
| Race/Ethnicity, Customized(Participants) | Medication With Sample and Demonstration | Medication Without Samples | Total |
|---|---|---|---|
| Race(Caucasian) | 5 | 6 | 11 |
| Ethnicity(Non-Hispanic) | 8 | 9 | 17 |
| Region of Enrollment(Participants) | Medication With Sample and Demonstration | Medication Without Samples | Total |
|---|---|---|---|
| United States | 9 | 9 | 18 |
Plan to share: No
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