Clinical trial NCT00926367: Two-week Study to Compare the Tolerance and Irritation Potential of Two Combination Topical Gel Acne Medications
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acne Vulgaris
Keywords: Acne
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
Collaborators: name: GlaxoSmithKline
First posted: 2009-06-23
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Skin Erythema (Redness)
timeFrame: Baseline, Day 1 through Day 14
measure: Skin Dryness
timeFrame: Baseline, Day 1 through Day 14
Secondary outcomes:
measure: Skin Moisture and Hydration
timeFrame: Baseline, Days 3, 7, and 14
measure: Skin Hydration
timeFrame: Baseline, 4 hrs. post 1st Treatment, Days 3, 7, and 14
measure: Self Assessment of Burning
timeFrame: Baseline, Day 1 through Day 14
measure: Self Assessment of Stinging
timeFrame: Baseline, Day 1 through Day 14
measure: Self Assessment of Dryness
timeFrame: Baseline, Day 1 through Day 14
measure: Self Assessment of Texture (Roughness)
timeFrame: Baseline, Day 1 through Day 14
measure: Self Assessment of Pain
timeFrame: Baseline, Day 1 through Day 14
measure: Self Assessment of Crusting
timeFrame: Baseline, Day 1 through Day 14
measure: Self Assessment of Blistering
timeFrame: Baseline, Day 1 through Day 14
measure: Self Assessment of Oiliness
timeFrame: Baseline, Day 1 through Day 14
measure: Product Acceptability and Preference Questionnaire - How do You Rate the Comfort of the Skin Where You Are Currently Treating With the Study Product?
timeFrame: Day 14
measure: Product Acceptability and Preference Questionnaire - How Compliant Were You With Applying the Study Product Each and Every Day?
timeFrame: Day 14
measure: Product Acceptability and Preference Questionnaire - Did You Feel That Your Skin Was Hydrated and Moisturized While You Were on Your Study Product?
timeFrame: Day 14
measure: Product Acceptability and Preference Questionnaire - Was the Study Product Easy to Use With Make-up?
timeFrame: Day 14
measure: Product Acceptability and Preference Questionnaire - What Was Your Overall Satisfaction of the Study Product?
timeFrame: Day 14
measure: Product Acceptability and Preference Questionnaire - How do You Rate the Ease of Application of the Study Product?
timeFrame: Day 14
Other outcomes:
Locations:
city: Broomall
country: United States
facility: cyberDERM
state: Pennsylvania
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: