NCT00357916

Study to Determine the Sensitizing Potential of PEP005 Topical Gel in Healthy Volunteers Using a Repeat Insult Patch Test Design

A Randomized, Controlled Study to Evaluate the Sensitizing Potential of PEP005 Topical Gel (0.01% Concentration) in Healthy Volunteers Using a Repeat Insult Patch Test Design

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 200 (planned)
• Sponsor: Peplin · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

To determine the sensitisation potential of PEP005 Topical Gel (0.01% concentration) on normal skin To evaluate skin irritation

Detailed description

This is a repeat insult patch test study. On treatment days, the investigational product PEP005 Topical Gel (0.01% concentration) and vehicle control will be applied under open conditions to sites on the infrascapular region of the back 3 times weekly for 3 weeks (9 applications in total) during the induction phase. Following a rest period of approximatley 10-14 days, a single challenge application will be performed. Local tolerability will be assessed visually using an ordinal scoring system. If a cutaneous response observed in the challenge phase indicates possible sensitisation, or at the discretion of the investigator, a rechallenge will occur

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	PEP005 Topical Gel (0.01% concentration)

Timeline

• Start date: 2006-06-01
• Primary completion: 2006-10-01
• Completion: 2006-10-01
• First posted: 2006-07-28
• Last updated: 2016-04-05

Locations

1 site across 1 country: United States