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| Name | Class |
|---|---|
| Galderma R&D | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Medication with sample and demonstration | Experimental | Subjects will receive a sample tube of the Adapalene + benzoyl peroxide samples with demonstration of how to use it at the first visit. |
|
| Medication without samples | Active Comparator | Subjects will receive the Adapalene + benzoyl peroxide from standard tube without a sample or demonstration of proper use of the medication. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adapalene + benzoyl peroxide samples | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 6 weeks |
| Change in Acne Lesion Count |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven R Feldman, MD, PhD | Wake Forest University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27104 | United States |
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Subjects were recruited from Wake Forest Baptist Medical Center Dermatology clinic and phone database of previously seen mild to moderate acne.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Medication Without Samples | Subjects will receive the Adapalene + benzoyl peroxide from standard tube without a sample or demonstration of proper use of the medication. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | the median and ranges of subject ages for the sample and no sample group were 19 years, primarily female identifying as Caucasian. | Posted | Median | Standard Deviation | percentage of doses | Baseline to 6 weeks |
|
One year
Eighteen subjects completed questionnaires regarding side effects.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dryness | Skin and subcutaneous tissue disorders | Systematic Assessment | Dry skin |
This small pilot study subgroup analyses was limited.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Irma M Richardsom, MHA | Wake Forest University Health Sciences | 336-716-2903 | irichard@wakehealth.edu |
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| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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| ID | Term |
|---|---|
| D000068816 | Adapalene |
| D000068801 | Adapalene, Benzoyl Peroxide Drug Combination |
| ID | Term |
|---|---|
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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|
| Adapalene + benzoyl peroxide from standard tube | Drug | Subjects are instructed to apply the combination adapalene 0.1% plus benzoyl peroxide 2.5% gel once daily to all affected areas. |
|
|
Change in total count of acne lesions from baseline visit to Week 6 visit
| Baseline and 6 weeks |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | 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. |
|
|
| 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. | Posted | Count of Participants | Participants | Baseline and 6 weeks |
|
|
|
| Secondary | Change in Acne Lesion Count | Change in total count of acne lesions from baseline visit to Week 6 visit | Posted | Mean | Full Range | lesions | Baseline and 6 weeks |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 6 |
| 10 |
| EG001 | 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. | 0 | 10 | 0 | 10 | 6 | 10 |
| itching | Skin and subcutaneous tissue disorders | Systematic Assessment | Skin itching |
|
| redness | Skin and subcutaneous tissue disorders | Systematic Assessment | red skin |
|
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| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D001585 | Benzoyl Peroxide |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| AGA (1 almost clear) |
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| Week 6 |
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| Week 6 (inflammatory Lesion) |
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| Week 6 (Non-inflammatory Lesion) |
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