CompletedPhase 4

A Five Day Clinical Study to Examine the Effects of a Benzoyl Peroxide Treatment on Facial Acne Lesions

United States90 participantsStarted 2014-02

Plain-language summary

5 Day study to assess how quickly a topical acne product begins to work.

Who can participate

Age range12 Years – 45 Years

SexALL

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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.
✓. Fitzpatrick Skin Type I - V.
✓. Male or female aged from 12 to 45 years, inclusive, at time of consent.
✓. Mild to moderate facial acne vulgaris as determined by the Investigator, with a minimum of 10 inflammatory lesions (papules plus pustules, including nasal lesions) and a minimum of 10 non-inflammatory lesions (open and closed comedones, including nasal lesions).
✓. Three appropriate and evaluable target lesions, as judged by the Investigator.
✓. 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. Acceptable contraceptive methods include the following:

Exclusion criteria

✕. Has any nodulocystic lesions at the baseline evaluation.
✕. Female who is pregnant, trying to become pregnant, or breastfeeding.
✕. 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.
✕. Had skin cancer treatment in preceding 12 months.
✕. Has damaged skin on facial areas (e.g., sunburn, tattoo, or scar).
✕. Had any medical procedure (e.g., laser resurfacing, chemical peel, or plastic surgery) on facial areas in preceding 12 months.
✕. Had any cosmetic procedure (e.g., microdermabrasion) on facial areas within 8 weeks of the baseline visit.

What they're measuring

To Assess the Percentage Change in Acne Lesion Swelling (Height) of the Target Lesion for 3% Benzoyl Peroxide (BPO) Gel Test Product Relative to the Vehicle Gel After 4 Once-daily Applications.

Timeframe: Baseline to Day 4

Trial details

NCT IDNCT02052752

SponsorGlaxoSmithKline

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2014-05

Results submitted2015-01-08

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