Two-week Study to Compare the Tolerance and Irritation Potential of Two Combination Topical Gel Acne Medications

Study Overview
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Brief Summary
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This is a single-blind (blinded expert grader), randomized, half-face study being conducted at one clinical site. On 1 side of the face, the subject will apply 1 of the 2 test products, antibiotic and benzoyl peroxide or benzoyl peroxide and adapalene gel and the contra lateral side of the face will remain non-treated to serve as a control. Approximately 25-30 male and female healthy subjects will be randomly assigned to each product

Detailed Description
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This is a single-blind (blinded expert grader), parallel group, randomized, half-face study being conducted at one clinical site. On 1 side of the face, the subject will apply 1 of the 2 test products, a topical antibiotic and benzoyl peroxide or benzoyl peroxide and adapalene and the contra lateral side of the face will remain non-treated to serve as a control. Approximately 25-30 male and female healthy subjects will be randomly assigned to each product. The subjects will be entered into a 2-week treatment phase. The once-daily applications for the study medication will be supervised at the site, Monday through Friday of each week. Subjects will apply the study product at home on Saturdays and Sundays. A blinded expert grader will rate comparative product tolerance on each week day (excluding Saturdays and Sundays) during the study before study product is applied. Subject questionnaires will be completed along with collection of all adverse events.

Official Title
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Two-week Study to Determine and Compare the Tolerance and Irritation Potential of Topical Antibiotic and Benzoyl Peroxide to Benzoyl Peroxide and Adapalene Topical Gel Acne Medications

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Drug: Clindamycin and benzoyl peroxide
* Drug: benzoyl peroxide 2.5% and adapalene 0.1% gel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects 18 to 45 years of age or older, able to complete the study and comply with study instructions. Female subjects of childbearing potential must have a negative pregnancy test. Sexually active women of childbearing potential participating in the study must have been using a medically acceptable form of contraception Capable of understanding and willing to provide signed and dated written voluntary informed consent (and any local or national authorization requirements) before any protocol specific procedures are performed. Is willing to discontinue use of all facial products (other than the cleanser provided and makeup or razor and facial shave product) on the face for the 3 days before their baseline/day 0 visit and use only the provided facial products and their normal makeup or razor and facial shaving product for the duration of the study. Is willing to avoid sunburn, tanning, tanning beds or other excessive sun exposure. Understands that if their skin tone changes significantly during the study it will be necessary to discontinue their participation. Exclusion Criteria: Male subjects that have facial beards (mustache and/or goatee is acceptable). Is a Type I diabetic. Has active or chronic skin allergies. Has a history of acute or chronic disease that might interfere with, or increase the risk of study participation. Has participated in other facial studies in the preceding 30 days or other clinical studies in preceding 14 days. Had skin cancer treatment in preceding 12 months. Has damaged skin on facial areas (eg, from sunburn, tattoos, scars). Had any medical procedure (eg, laser resurfacing, chemical peels, plastic surgery) to facial areas in preceding 12 months. Had any cosmetic procedure (eg, microdermabrasion, etc.) to facial areas within 8 weeks of the baseline visit. Live in the same household as currently enrolled subjects. Any other condition or factor the investigator or his duly assigned representative believes may affect the skin response or the interpretation of the test results.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Clinidamycin/ Benzoyl Peroxide<br>Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide (BPO). | Drug: Clindamycin and benzoyl peroxide<br>* Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide gel. This contains a topical antibiotic and benzoyl peroxide gel.<br>* Other names: Duac® Topical Gel (clindamycin and benzoyl peroxide.;|
| Active Comparator: Benzoyl peroxide and adapalene<br>Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide (BPO) and adapalene | Drug: benzoyl peroxide 2.5% and adapalene 0.1% gel<br>* Once-daily applications, to the randomized side of the face either left or right,benzoyl peroxide and adapalene gel<br>* Other names: benzoyl peroxide gel and adapalene gel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin Erythema (Redness) | Assessment of erythema as part of an evaluation of tolerance of two treatments: clindamycin and benzoyl peroxide or dapsone gel. This was done by visual assessment by an independent blinded grader using the grading scale shown below. Grade Description 0 None 2 Mild erythema 4 Moderate confluent erythema 6 Marked erythema with some edema 8 Marked erythema, edema, possible erosion | Baseline, Day 1 through Day 14 | 
| Skin Dryness | The amount of dryness on the left and right cheek of each panelist. The scale used to evaluate skin dryness is: Grade Description 0 None 2 Slight flaking 4 Moderate flaking/scaling 6 Marked scaling / slight fissuring 8 Severe scaling, fissuring Expert Grader assessments of dryness were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14. | Baseline, Day 1 through Day 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin Moisture and Hydration | To assess skin moisture and hydration using transepidermal water loss (TEWL). Results are measured on a continuous scale. Higher values indicate greater water loss/ lower skin moisture levels. Evaporative water loss measurements provide an instrumental assessment of skin barrier function(one of the layers of the skin. Damage leads to a disruption of the barrier that is accompanied by elevated water loss rates and affects skin moisture and hydration. Higher values indicate greater water loss. | Baseline, Days 3, 7, and 14 | 
| Skin Hydration | The ability of an alternating current to flow through the stratum corneum is an indirect measure of its water content. The value recorded is expressed in microsiemens. Higher values indicate greater levels of skin hydration. Test results were compared to measurements from the other side of the face, which was not treated instead of referring to a normal range. A normal range does not exist for this measurement. Instead, the non-treated side of the face was used as a control to determine the normal level of skin hydration. | Baseline, 4 hrs. post 1st Treatment, Days 3, 7, and 14 | 
| Self Assessment of Burning | The amount of burning on the left and right cheek of each panelist. The scale used to evaluate burning is: Scale Description: (scale: 0 = none to 3 = severe) Subject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14. | Baseline, Day 1 through Day 14 | 
| Self Assessment of Stinging | The amount of stinging on the left and right cheek of each panelist. The scale used to evaluate stinging is: Scale Description: (scale: 0 = none to 3 = severe) Subject Self Assessments of stinging were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14. | Baseline, Day 1 through Day 14 | 
| Self Assessment of Dryness | The amount of dryness on the left and right cheek of each panelist. The scale used to evaluate dryness is: Scale Description: (scale: 0 = none to 3 = severe) Subject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14. | Baseline, Day 1 through Day 14 | 
| Self Assessment of Texture (Roughness) | The amount of roughness on the left and right cheek of each panelist. The scale used to evaluate roughness is: Scale Description: (scale: 0 = none to 3 = severe) Subject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14. | Baseline, Day 1 through Day 14 | 
| Self Assessment of Pain | The amount of pain on the left and right cheek of each panelist. The scale used to evaluate pain is: Scale Description: (scale: 0 = none to 3 = severe) Subject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14. | Baseline, Day 1 through Day 14 | 
| Self Assessment of Crusting | The amount of crusting on the left and right cheek of each panelist. The scale used to evaluate crusting is: Scale Description: (scale: 0 = none to 3 = severe) Subject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14. | Baseline, Day 1 through Day 14 | 
| Self Assessment of Blistering | The amount of blistering on the left and right cheek of each panelist. The scale used to evaluate blistering is: Scale Description: (scale: 0 = none to 3 = severe) Subject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14. | Baseline, Day 1 through Day 14 | 
| Self Assessment of Oiliness | The amount of oiliness on the left and right cheek of each panelist. The scale used to evaluate oiliness is: Scale Description: (scale: 0 = none to 3 = severe) Subject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14. | Baseline, Day 1 through Day 14 | 
| Product Acceptability and Preference Questionnaire - How do You Rate the Comfort of the Skin Where You Are Currently Treating With the Study Product? | The subject were presented with a questionnaire at day 14 (end of study) and was asked the following question: How do you rate the comfort of the skin where you are currently treating with the study product? The subject replied using the following scale: - Very Comfortable - Comfortable - Somewhat Comfortable - Somewhat Uncomfortable - Uncomfortable | Day 14 | 
| Product Acceptability and Preference Questionnaire - How Compliant Were You With Applying the Study Product Each and Every Day? | The subject were presented with a questionnaire at day 14 (end of study) and was asked the following question: How compliant were you with applying the study product each and every day? The subject replied using the following scale: 0 - Not Compliant at all (<50%) - Mostly Compliant (50%-79%) - Very Compliant (80%-100%) | Day 14 | 
| Product Acceptability and Preference Questionnaire - Did You Feel That Your Skin Was Hydrated and Moisturized While You Were on Your Study Product? | The subject were presented with a questionnaire at day 14 (end of study) and was asked the following question: Did you feel that your skin was hydrated and moisturized while you were on your study product? The subject replied using the following scale: 1 - Yes 0 - No | Day 14 | 
| Product Acceptability and Preference Questionnaire - Was the Study Product Easy to Use With Make-up? | The subject were presented with a questionnaire at day 14 (end of study) and was asked the following question: Was the study product easy to use with make-up? The subject replied using the following scale: 0 - Not Applicable - Very Easy - Easy - Neutral - Difficult - Very Difficult | Day 14 | 
| Product Acceptability and Preference Questionnaire - What Was Your Overall Satisfaction of the Study Product? | The subject were presented with a questionnaire at day 14 (end of study) and was asked the following question: What was your overall satisfaction of the study product? The subject replied using the following scale: - Very Satisfied - Satisfied - Neutral - Unsatisfied - Very Unsatisfied | Day 14 | 
| Product Acceptability and Preference Questionnaire - How do You Rate the Ease of Application of the Study Product? | The subject were presented with a questionnaire at day 14 (end of study) and was asked the following question: Was the study product easy to use with make-up? The subject replied using the following scale: 0 - Not Applicable - Very Easy - Easy - Neutral - Difficult - Very Difficult | Day 14 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acne