NCT01938482

Study to Evaluate the Safety, Tolerability and Pharmacokinetic of Single and 14 Day Repeat Topical Application of GSK1940029

Completed Phase 1 Last updated 9 May 2017

What this trial tests

Phase 1 trial testing 0.3% GSK1940029 gel in Acne Vulgaris in 55 participants. Completed in 17 February 2015.

Timeline

31 October 2013

Primary endpoint
17 February 2015

17 February 2015

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	single group
Masking	single
Primary purpose	treatment
Enrollment	55
Start date	31 October 2013
Primary completion	17 February 2015
Estimated completion	17 February 2015
Sites	1 location across Australia

Drugs / interventions tested

• 0.3% GSK1940029 gel — full drug profile →
• 1% GSK1940029 gel — full drug profile →
• 0.3%/1% vehicle gel only — full drug profile →

Conditions studied

• Acne Vulgaris — all drugs for Acne Vulgaris →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 18 to 65, any sex, with Acne Vulgaris. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 SCD117226 will be a randomized, single-blind, dose-rising study to evaluate the safety, tolerability and preliminary pharmacokinetics of single and 14 day repeat topical applications of GSK1940029 gel on the intact skin of healthy human subjects. Part 1: (single-dose) subjects will receive 0.3% or 1% GSK1940029 (or matching vehicle), as a single approximately (App) 24 hour (h) (22.5h) application to a surface area of 400 square centimeter (cm\^2) (0.3%), 400 cm\^2 (1%) or 1200 cm\^2 (1%), respectively, in each of three sequential cohorts. Part 2: (repeat-dose) subjects will receive 0.3% or 1% GSK1940029 (or matching vehicle), as 14 daily App24h (22.5h) application to a surface area of 400 cm\^2 (0.3%), 400 cm\^2 (1%) or 1200 cm\^2 (1%), respectively, in each of three sequential cohorts. Parts within Study SCD117225 and Study SCD117226 will have interdependencies. No significant primary irritation signal in Study SCD117225 Part 1 (primary irritation) would allow initiation of Study SCD117226 Part 1. Once safety, tolerability and exposure information are determined in Study SCD117226 Part 1, then Part 2 (cumulative irritation) of Study SCD117225 may be initiated along with Part 2 of Study SCD117226. 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 (facial irritation) of Study SCD117225.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. A Phase 1 Randomized, Placebo-Controlled Trial With a Topical Inhibitor of Stearoyl-Coenzyme A Desaturase 1 Under Occluded and Nonoccluded Conditions.
   Brigandi RA, Zhu J, Murnane AA, Reedy BA, et al · · 2019 · cited 10× · PMID 30650256 · DOI 10.1002/cpdd.644