NCT01984775

A Study to Evaluate the Irritation Potential of GSK2894512 Cream on Skin in Healthy Subjects

An Evaluator-Blinded Study to Evaluate the Cumulative Irritation Potential of Topically-Applied GSK2894512 Cream in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Stiefel, a GSK Company · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This study is conducted to assess the potential of topically-applied GSK2894512 cream at 3 concentrations (0.5%, 1%, and 2%) to induce skin irritation at the site of application in healthy subjects. Results from this study will be considered when selecting the concentration(s) of GSK2894512 to evaluate in the Phase II and Phase III clinical safety and efficacy studies. Approximately 40 subjects will be enrolled in order to have at least 30 evaluable subjects complete the study. The total duration of subject participation may be up to 50 days.

Conditions

• Psoriasis

Interventions

Type	Name	Description
DRUG	GSK2894512 cream	GSK2894512 is a white to off-white cream that will be applied topically in 3 different concentrations (0.5% \[5 milligram (mg)/gram (g)\], 1% \[10 mg/g\], and 2% \[20 mg/g\]).
DRUG	Vehicle cream	Vehicle cream does not contain any active pharmaceutical ingredient.
DRUG	Positive control	Positive control contains sodium lauryl sulfate solution 0.1% (1 mg/g).
DRUG	Negative control	Negative control contains petrolatum.

Timeline

• Start date: 2013-10-30
• Primary completion: 2014-07-02
• Completion: 2014-07-02
• First posted: 2013-11-15
• Last updated: 2017-06-16

Locations

2 sites across 2 countries: United States, Germany