NCT02637206

Skin Irritation Study of GSK2894512 Cream

Skin Irritation Study of GSK2894512 Cream-An Evaluator-Blinded Study to Evaluate the Skin Irritation of GSK2894512 Cream and Placebo Following Single Application by Simple-Patch Test and Photo-Patch Test, and Repeat Application Under Non-occlusive Condition in Healthy Japanese Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 20 Years – 64 Years
• Healthy volunteers: Accepted

Summary

GSK2894512 is a novel anti-inflammatory agent that is currently under development for the topical treatment of atopic dermatitis and chronic plaque psoriasis. This study will be a Phase I, single-center, randomized, partial-blinded (evaluator blinded) study which consists of two parts (Part 1 and 2). Part 1 of this study will assess skin irritation following a single application of GSK2894512 cream at 2 concentrations (e.g. 0.5% and 1%) and placebo by simple-patch test and photo-patch test under semi-occlusive conditions in 20 healthy Japanese volunteers. Part 2 of this study will assess skin irritation following repeat application at 0.5% and 1% of GSK2894512 cream and placebo for 7 days under non-occlusive condition in 6 healthy Japanese volunteers. The study will have Screening visit which will occur within 30 days from the Day 1 visit of each part. Eligible subjects will be able to participate either of Part 1 or Part 2. Subjects will visit the site on Day -1, and hospitalized until the end of all assessments on Day 4 (Part 1) or Day 7 (Part 2). Subjects will re-visit the site on Day 8 (Part 1) or Day 15 (Part 2) for follow-up assessments. This study will be the first to evaluate the safety, tolerability and pharmacokinetics of GSK2894512 cream after single and repeat application in Japanese subjects. Results from this study will enable further clinical investigation in the Japanese population.

Conditions

• Dermatitis, Atopic

Interventions

Type	Name	Description
DRUG	GSK2894512 Cream	GSK2894512 cream supplied will be white to off-white cream packaged in 28-gram laminate tubes of 2 concentrations: 0.5% and 1%, to be applied topically.
DRUG	Vehicle Cream	Vehicle Cream (placebo cream without active ingredient) supplied will be white to off-white cream packaged in 28-gram laminate tubes, to be applied topically.
DRUG	Empty Patch	Empty patches without any ingredients will be used as negative control.

Timeline

• Start date: 2015-10-27
• Primary completion: 2015-12-02
• Completion: 2015-12-02
• First posted: 2015-12-22
• Last updated: 2017-07-18

Locations

1 site across 1 country: Japan