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Japanese Phase 1 Study of GSK2585823

NCT01428466 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2017-08-04

No results posted yet for this study

Summary

This is a randomized, single-center, partial-blind study to evaluate the dermal irritation potential and to detect photo-toxicity and photo-allergy potential of GSK2585823, Benzoyl peroxide BPO 5% gel, Benzoyl peroxide 3% gel, vehicle gel and negative control (distilled water) applied using Finn-Chambers® by single and 7-day repeat patch test in 20 Japanese healthy male and female volunteers. Finn-Chambers containing no investigational product will be applied in the same manner.

Safety will also be assessed by measurement of vital signs, electrocardiograms, safety laboratory data and review of adverse events.

Conditions

  • Acne Vulgaris

Interventions

DRUG

GSK2585823

CLDM1%/BPO3%

DRUG

Benzoyl peroxide 3%

Benzoyl peroxide 3%

DRUG

Benzoyl peroxide 5%

Benzoyl peroxide 5%

OTHER

Vehicle

placebo

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-11-18
Primary Completion
2011-02-15
Completion
2011-02-15

Countries

  • Japan

Study Locations

More Related Trials

Entities

Companies

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 NCT01428466 on ClinicalTrials.gov