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

Condition(s) targeted: Acne Vulgaris

Intervention: Clindamycin and benzoyl peroxide (Drug); benzoyl peroxide 2.5% and adapalene 0.1% gel (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Stiefel, a GSK Company

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

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

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 design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

Skin Erythema (Redness)

Skin Dryness

Secondary outcome:

Skin Moisture and Hydration

Skin Hydration

Self Assessment of Burning

Self Assessment of Stinging

Self Assessment of Dryness

Self Assessment of Texture (Roughness)

Self Assessment of Pain

Self Assessment of Crusting

Self Assessment of Blistering

Self Assessment of Oiliness

Product Acceptability and Preference Questionnaire - How do You Rate the Comfort of the Skin Where You Are Currently Treating With the Study Product?

Product Acceptability and Preference Questionnaire - How Compliant Were You With Applying the Study Product Each and Every Day?

Product Acceptability and Preference Questionnaire - Did You Feel That Your Skin Was Hydrated and Moisturized While You Were on Your Study Product?

Product Acceptability and Preference Questionnaire - Was the Study Product Easy to Use With Make-up?

Product Acceptability and Preference Questionnaire - What Was Your Overall Satisfaction of the Study Product?

Product Acceptability and Preference Questionnaire - How do You Rate the Ease of Application of the Study 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.

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Both.

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.

cyberDERM, Broomall, Pennsylvania 19008, United States

Starting date: May 2009
Last updated: May 1, 2015