Clinical trial NCT00964366: Study to Determine and Compare the Tolerance and Irritation Potential of Topical Acne Medications
Official title: Two-week Study to Determine and Compare the Tolerance and Irritation Potential of Clindamycin and Benzoyl Peroxide to Dapsone Gel Topical Acne Medications
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acne Vulgaris
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
Collaborators: name: GlaxoSmithKline
First posted: 2009-08-24
Enrollment: 53
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 randomized, half-face study. On 1 side of the face, the subject will apply 1 of the 2 test products, clindamycin and benzoyl peroxide or dapsone gel and the contra lateral 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 or dapsone 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 without facial acne, aged 18 to 45, will be randomly assigned to each product.

The eligible subjects who qualify will be entered into a 2-week treatment phase. The first of application of the study medication will be supervised at the site, Monday through Friday of each week. Any additional applications should be applied by the subjects at home each evening and the times of application recorded on a diary card. 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 during the study before study product is applied.

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

Duplicate sebum samples will be taken from the left and right forehead areas and assessed.

Subject 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.
* Has a Fitzpatrick Skin Type of I, II, or III.
* 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.
* Is willing to refrain from exercising prior to their instrument appointments.
* Is willing to refrain from showering or drinking caffeinated beverages within 1 hour prior to their instrument visits.
* Is willing to report to the site for each visit with a clean face and no makeup.
* 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.
* 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. A woman of childbearing potential is defined as one who is biologically capable of becoming pregnant; including perimenopausal women who are less than 2 years from their last menses.

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 (e.g., laser resurfacing, chemical peels, plastic surgery) to facial areas in preceding 12 months.
* Had any cosmetic procedure (e.g., 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.
* Live in the same household as currently enrolled subjects.
* Employees of investigator/clinical research organization (CRO) or Stiefel Laboratories 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: Skin Erythema (Redness)
timeFrame: 2 Weeks
measure: Skin Dryness
timeFrame: Baseline, Day 1through Day 14
Secondary outcomes:
measure: Transepidermal Water Loss (TEWL)
timeFrame: 2 Weeks
measure: Sebum Measurements
timeFrame: 2 weeks
measure: Skin Hydration
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: