Clinical trial NCT01015638: Compare the Tolerance of Clindamycin 1% /Benzoyl Peroxide (BPO) 5% Gel to Clindamycin 1.2%/ BPO 2.5% Topical Medications
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acne Vulgaris
Keywords: Healthy volunteers
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
Collaborators: name: GlaxoSmithKline
First posted: 2009-11-18
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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, clindamycin and benzoyl peroxide 5%) or clindamycin and benzoyl peroxide 2.5%) and the other 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.

Instruments will be used to measure transepidermal water loss (TEWL) to assess skin moisture in order 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Erythema (Redness)
timeFrame: 14 days
measure: Skin Dryness
timeFrame: 14 days
Secondary outcomes:
measure: Skin Moisture and Hydration
timeFrame: 14 days
measure: Changes in the Skin Surface Hydration
timeFrame: 14 days
measure: Subject Tolerability - Burning
timeFrame: 2 weeks
measure: Subject Tolerability - Stinging
timeFrame: 2 weeks
measure: Subject Assessment - Dryness
timeFrame: 2 weeks
measure: Subject Assessment - Roughness
timeFrame: 2 weeks
measure: Subject Assessment - Pain
timeFrame: 2 Weeks
measure: Subject Assessment - Crusting
timeFrame: 2 Weeks
measure: Subject Assessment - Blistering
timeFrame: 2 Weeks
measure: Subject Assessment - Oiliness
timeFrame: 2 Weeks
Other outcomes:
Locations:
city: Broomall
country: United States
facility: cyberDERM
state: Pennsylvania
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: