Acne Vulgaris
Conditions
Keywords
adherence, adapalene, benzoyl peroxide, sample, topical treatment
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.
Interventions
DRUGAdapalene + 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.
DRUGAdapalene + 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.
Sponsors
Galderma R&D
Wake Forest University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to Study Medication | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Acne Global Assessment | 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 | Baseline and 6 weeks | Change in total count of acne lesions from baseline visit to Week 6 visit |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited from Wake Forest Baptist Medical Center Dermatology clinic and phone database of previously seen mild to moderate acne.
Participants by arm
| Arm | Count |
|---|---|
| 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.
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.
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. | 9 |
| Medication Without Samples Subjects will receive the Adapalene + benzoyl peroxide from standard tube without a sample or demonstration of proper use of the medication.
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. | 9 |
| Total | 18 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 |
Baseline characteristics
| Characteristic | Medication With Sample and Demonstration | Medication Without Samples | Total |
|---|---|---|---|
| Age, Customized Age | 19 years | 19 years | 19 years |
| Race/Ethnicity, Customized Ethnicity(Non-Hispanic) | 8 Participants | 9 Participants | 17 Participants |
| Race/Ethnicity, Customized Race(Caucasian) | 5 Participants | 6 Participants | 11 Participants |
| Region of Enrollment United States | 9 Participants | 9 Participants | 18 Participants |
| Sex: Female, Male Female | 8 Participants | 6 Participants | 14 Participants |
| Sex: Female, Male Male | 1 Participants | 3 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 6 / 10 | 6 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
Primary
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
Population: the median and ranges of subject ages for the sample and no sample group were 19 years, primarily female identifying as Caucasian.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Medication With Sample and Demonstration | Adherence to Study Medication | 86 percentage of doses | Standard Deviation 2.2 |
| Medication Without Samples | Adherence to Study Medication | 71 percentage of doses | Standard Deviation 0.34 |
Secondary
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
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Medication With Sample and Demonstration | Change in Acne Global Assessment | Baseline | AGA (3 moderate) | 4 Participants |
| Medication With Sample and Demonstration | Change in Acne Global Assessment | Week 6 | AGA (2-mild) | 3 Participants |
| Medication With Sample and Demonstration | Change in Acne Global Assessment | Baseline | AGA (2-mild) | 5 Participants |
| Medication With Sample and Demonstration | Change in Acne Global Assessment | Week 6 | AGA (3 moderate) | 2 Participants |
| Medication With Sample and Demonstration | Change in Acne Global Assessment | Baseline | AGA (1 almost clear) | 0 Participants |
| Medication With Sample and Demonstration | Change in Acne Global Assessment | Week 6 | AGA (1 almost clear) | 4 Participants |
| Medication Without Samples | Change in Acne Global Assessment | Baseline | AGA (1 almost clear) | 0 Participants |
| Medication Without Samples | Change in Acne Global Assessment | Baseline | AGA (2-mild) | 6 Participants |
| Medication Without Samples | Change in Acne Global Assessment | Baseline | AGA (3 moderate) | 3 Participants |
| Medication Without Samples | Change in Acne Global Assessment | Week 6 | AGA (1 almost clear) | 2 Participants |
| Medication Without Samples | Change in Acne Global Assessment | Week 6 | AGA (2-mild) | 4 Participants |
| Medication Without Samples | Change in Acne Global Assessment | Week 6 | AGA (3 moderate) | 3 Participants |
Secondary
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
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Medication With Sample and Demonstration | Change in Acne Lesion Count | Basleine (Inflammatory Lesions) | 3 lesions |
| Medication With Sample and Demonstration | Change in Acne Lesion Count | Baseline (Non-Inflammatory) | 33 lesions |
| Medication With Sample and Demonstration | Change in Acne Lesion Count | Week 6 (inflammatory Lesion) | 1 lesions |
| Medication With Sample and Demonstration | Change in Acne Lesion Count | Week 6 (Non-inflammatory Lesion) | 19 lesions |
| Medication Without Samples | Change in Acne Lesion Count | Week 6 (Non-inflammatory Lesion) | 35 lesions |
| Medication Without Samples | Change in Acne Lesion Count | Basleine (Inflammatory Lesions) | 2 lesions |
| Medication Without Samples | Change in Acne Lesion Count | Week 6 (inflammatory Lesion) | 1 lesions |
| Medication Without Samples | Change in Acne Lesion Count | Baseline (Non-Inflammatory) | 38 lesions |