Study to Investigate the Irritation Potential of GSK1940029 Gel

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.

Conditions

• Acne Vulgaris

Interventions

DRUG

0.3% GSK1940029 gel

200 mg of the gel will be applied to individual patches by using a spatula

DRUG

1% GSK1940029 gel

200 mg of the gel will be applied to individual patches by using a spatula

DRUG

0.3%/1% vehicle gel only

200 mg of the gel will be applied to individual patches by using a spatula

OTHER

Sterile distilled water

200 µL of the solution will be applied to individual patches by using a pipette or syringe

OTHER

0.5% SLS in sterile distilled water

200 µL of the solution will be applied to individual patches by using a pipette or syringe

OTHER

0.1% SLS in sterile distilled water

200 µL of the solution will be applied to individual patches by using a pipette or syringe

OTHER

Patch only

Only patch will be applied

Sponsors & Collaborators

• GlaxoSmithKline

  lead INDUSTRY

Principal Investigators

• GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2013-10-14

Primary Completion

2015-04-10

Completion

2015-04-10

Countries

• Australia

Study Locations