Official Title: “Two-week Study to Determine and Compare the Tolerance and Irritation Potential of Duac® Topical Gel (Clindamycin 1% and Benzoyl Peroxide 5%) to ACANYA™ Gel (Clindamycin Phosphate 1.2% and Benzoyl Peroxide 2.5%) Topical Acne Medications”

This is a single-blind (blinded expert grader) study that will enroll 25-30 healthy volunteers without facial acne. On 1 side of the face, the subject will apply 1 of the 2 test products, clindamycin and benzoyl peroxide 5% or clindamycin phosphate and benzoyl peroxide 2.5% and the other side of the face will remain non-treated to serve as a control.

Study Type: Interventional

Study Design: Treatment, Randomized, Single Blind (Investigator), Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: September 2009

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, clindamycin and benzoyl peroxide 5%) or clindamycin and benzoyl peroxide 2.5%) 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 without facial acne, aged 18 to 45, will be randomly assigned to each product.

The eligible subjects (screened 3 days prior to randomization) who qualify will be entered into a 2-week treatment phase. The once-daily applications for the clindamycin and benzoyl peroxide 5%and clindamycin phosphate and benzoyl peroxide 2.5%) will be supervised at the site, Monday through Friday of each week. Subjects will apply the study product at home on Saturdays and Sundays and record the times of application on a diary card.

A blinded expert grader will rate comparative product tolerance in terms of erythema and dryness on each week day (excluding Saturdays and Sundays) during the study before study product is applied.

Instrumentation measurements of TEWL will be utilized to evaluate product mildness.

Instrumentation measurements of skin surface conductance will be utilized to evaluate product performance in terms of level of skin hydration.

Subjects will complete questionnaires and all adverse events will be recorded.

Intervention(s) in this Clinical Trial

• Drug: clindamycin and benzoyl peroxide 5% gel
  • Once-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide 5% gel.
• Drug: clindamycin phosphate and benzoyl peroxide 2.5% gel.
  • Once daily application of clindamycin phosphate and benzoyl peroxide 2.5% gel

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Once-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide 5% gel.
• Active Comparator: 2
  • Once Daily application of clindamycin phosphate and benzoyl peroxide 2.5% gel.

Primary Measures

• To determine and compare the tolerability and irritation potential of clindamycin and benzoyl peroxide 5%) and clindamycin phosphate and benzoyl peroxide 2.5% using visual assessments by an independent blinded grader.
  • Time Frame: 2 weeks
    Safety Issue?: No

Secondary Measures

• To assess potential changes in the integrity of stratum corneum barrier and skin surface hydration and to assess subject tolerability through a skin assessment questionnaire and the Product Acceptability and Preference Questionnaire.
  • Time Frame: 2 Weeks
    Safety Issue?: No

Inclusion Criteria:

• 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.
• Male and female subjects aged from 18 to 45 years at time of consent.
• 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 not change brands of makeup or razor and facial shave product during the study.
• Is willing to refrain from using any facial product on the face other than study products and their normal makeup or razor and facial shave product for the duration of the study.
• Able to complete the study and to comply with study instructions.
• Sexually active females of childbearing potential participating in the study must agree to use a medically acceptable method of contraception while receiving protocol-assigned product

Exclusion Criteria:

• Female subjects who are pregnant, trying to become pregnant, or breast feeding.
• 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.
• Use of topical retinoids or related agents for the treatment of acne or photoaging in the preceding 6 months.
• Any dermatological disorder, which in the investigator's opinion, may interfere with the accurate evaluation of the subject's facial appearance.
• Has known sensitivities or allergies to cosmetics, soaps, fragrances, or any of the ingredients in the test products.
• Is currently going through menopause and experiencing hot flashes.
• Received any investigational drug within 30 days of study day 0 or who are scheduled to receive an investigational drug other than the study product during the study.
• Currently using any medication, which in the opinion of the investigator may affect the evaluation of the study product or place the subject at undue risk (including but not limited to asthma medications, oral steroids, rifampin, anticonvulsants, St.
• John's wart).
• Currently taking any topical or oral erythromycin-containing products.
• History of regional enteritis, ulcerative colitis, or antibiotic-associated colitis.
• Currently suffering from any disease or condition, which in the opinion of the investigator may affect the evaluation of the study product or place the subject at undue risk.
• Live in the same household as currently enrolled subjects.
• Employees of investigator/ clinical research organization (CRO) or Stiefel, a GSK
• Company involved in the study, or an immediate family member (partner, offspring, parents, siblings or sibling's offspring) of an employee involved in the study.
• 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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 45 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Stiefel, a GSK Company

Overall Clinical Trial Officials and Contacts

Lou Barbato, MD Study Director Stiefel, a GSK Company  

Information obtained from ClinicalTrials.gov on February 04, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01015638

Study ID Number: C0000-409

ClinicalTrials.gov Identifier: NCT01015638

Health Authority: United States: Institutional Review Board