Study to Investigate the Irritation Potential of GSK1940029 Gel
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 1

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.
    


Intervention name(s): 0.3% GSK1940029 gel; 1% GSK1940029 gel; 0.3%/1% vehicle gel only; Sterile distilled water; 0.5% SLS in sterile distilled water; 0.1% SLS in sterile distilled water; Patch only
Intervention type(s): Drug; Drug; Drug; Other; Other; Other; Other
Intervention description(s): 200 mg of the gel will be applied to individual patches by using a spatula; 200 mg of the gel will be applied to individual patches by using a spatula; 200 mg of the gel will be applied to individual patches by using a spatula; 200 µL of the solution will be applied to individual patches by using a pipette or syringe; 200 µL of the solution will be applied to individual patches by using a pipette or syringe; 200 µL of the solution will be applied to individual patches by using a pipette or syringe; Only patch will be applied
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: SCD1; Gel; Topical Administration; Acne