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
Overview
- Phase
- Phase 4
- Intervention
- Clindamycin and BPO 5% gel
- Conditions
- Acne Vulgaris
- Sponsor
- Stiefel, a GSK Company
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Erythema (Redness)
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
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.
Arms & Interventions
Clindamycin and BPO 5% gel
Once-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide (BPO) 5% gel.
Intervention: Clindamycin and BPO 5% gel
Clindamycin phosphate and BPO 2.5% gel
Once Daily application of clindamycin phosphate and benzoyl peroxide (BPO) 2.5% gel.
Intervention: Clindamycin phosphate and benzoyl peroxide 2.5% gel.
Outcomes
Primary Outcomes
Erythema (Redness)
Time Frame: 14 days
Compare tolerability of clindamycin and benzoyl peroxide (BPO) 5% and clindamycin phosphate and benzoyl peroxide 2.5% using visual assessments by an independent blinded grader. Erythema (redness) was evaluated using the following scale: Erythema Grade Description 0 = None 2 = Mild erythema 4 = Moderate confluent erythema 6 = Marked erythema with some edema 8 = Marked erythema, edema, possible erosion
Skin Dryness
Time Frame: 14 days
Visual Dryness was evaluated using the following scale: Grade 0 = None 2 = Slight flaking 4 = Moderate flaking/scaling 6 = Marked scaling / slight fissuring 8 Severe scaling, fissuring
Secondary Outcomes
- Skin Moisture and Hydration(14 days)
- Changes in the Skin Surface Hydration(14 days)
- Subject Tolerability - Burning(2 weeks)
- Subject Tolerability - Stinging(2 weeks)
- Subject Assessment - Dryness(2 weeks)
- Subject Assessment - Roughness(2 weeks)
- Subject Assessment - Pain(2 Weeks)
- Subject Assessment - Crusting(2 Weeks)
- Subject Assessment - Blistering(2 Weeks)
- Subject Assessment - Oiliness(2 Weeks)