Study to Investigate the Irritation Potential of GSK1940029 Gel
Status:
Completed
Trial end date:
2015-04-10
Target enrollment:
Participant gender:
Summary
The proposed indication for GSK1940029 is topical treatment of acne, the early clinical plan
will evaluate the irritation potential of GSK1940029 (Study SCD117225 - 3 Part study); and
safety, tolerability and pharmacokinetics of GSK1940029 (Study SCD117226 - 2 Part study),
after topical administration on healthy subjects and acne patients. Study SCD117225 will be a
randomized, single-blind, three part study, to evaluate the primary irritation potential
(Part 1), cumulative irritation potential (Part 2) of two concentrations of GSK1940029 gel
applied to the intact skin of healthy subjects, and the facial irritation potential of one or
two concentrations of GSK1940029 applied to the face of acne patients (Part3). In Part 1 and
Part 2 the following 6 treatments will be applied using individual patches: (A) 200
milligrams (mg) of 0.3% GSK1940029 gel, (B) 200 mg of 1% GSK1940029 gel, (C) 200 mg of
0.3%/1% vehicle gel only (vehicle control), (D) 200 microliters (µL) of sterile distilled
water (negative irritant control), (E) 200 µL of - 0.5% sodium lauryl sulfate (SLS) in
sterile distilled water for Part 1/0.1% SLS in sterile distilled water for Part 2 (positive
irritant control), and (F) Patch only (patch control). Each treatment will be randomized to
one of six designated locations on either upper arm or other locations, such as the lower or
upper back, within each subject. The same treatment will be reapplied to the same location on
subsequent days. Each treatment will be applied daily for 2 days in Part 1, and daily for 21
days in Part 2. In Part 3, each patient will apply a thin coat of one or two concentration of
GSK1940029 gel or vehicle to acne affected facial/neck skin by hand, once daily for 28 days.
Parts within Study SCD117225 and Study SCD117226 will have interdependencies. No significant
primary irritation signal in Study SCD117225 Part 1 would allow initiation of Study SCD117226
Part 1 (single dose application). Once safety, tolerability and exposure information are
determined in Study SCD117226 Part 1, Part 2 of Study SCD117225 may be initiated along with
Part 2 (14-day repeat dose application). No significant cumulative irritation signal (study
SCD117225 Part 2) in combination with adequate 14-day safety (study SCD117226 Part 2) would
allow initiation of Part 3 of Study SCD117225.