MedTrace Logo

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

NCT01984775 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2017-06-16

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Stiefel, a GSK Company

    lead INDUSTRY

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-10-30
Primary Completion
2014-07-02
Completion
2014-07-02

Countries

  • United States
  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01984775 on ClinicalTrials.gov