Status:
COMPLETED
Study to Determine and Compare the Tolerance and Irritation Potential of Topical Acne Medications
Lead Sponsor:
Stiefel, a GSK Company
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Acne Vulgaris
Eligibility:
All Genders
18-45 years
Phase:
PHASE4
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 w...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT00964366
Start Date
July 1 2009
End Date
August 1 2009
Last Update
May 30 2017
Active Locations (1)
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1
cyberDERM
Broomall, Pennsylvania, United States, 19008