NCT00700063

A Multicenter Study to Evaluate the Safety and Efficacy of PEP005 Topical Gel When Used to Treat Actinic Keratoses on the Head (Face or Scalp)

A Multicenter, Randomized, Double-blind, Vehicle-controlled, Dose-ranging Study to Evaluate the Safety and Efficacy of 0.005%, 0.01% and 0.015% PEP005 Topical Gel When Used to Treat Actinic Keratoses on the Head (Face or Scalp)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 265 (actual)
• Sponsor: Peplin · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This Phase IIb study is designed to assess the safety and efficacy of 0.005%, 0.01% and 0.015% PEP005 Topical Gel when applied to an area of skin, containing 4-8 AK lesions on the face or scalp.

Conditions

• Actinic Keratosis

Interventions

Type	Name	Description
DRUG	PEP005 Topical Gel	0.005%, two days treatment
DRUG	PEP005 Topical Gel	0.01%, two days treatment
DRUG	PEP005 Topical Gel	0.015%, two days treatment
DRUG	Vehicle gel	two days treatment
DRUG	PEP005 Topical Gel	0.005%, three days treatment
DRUG	PEP005 Topical Gel	0.01%, three days treatment
DRUG	PEP005 Topical Gel	0.015%, three days treatment
DRUG	Vehicle gel	three days treatment

Timeline

• Start date: 2008-06-01
• Primary completion: 2008-10-01
• Completion: 2008-10-01
• First posted: 2008-06-18
• Last updated: 2015-04-14
• Results posted: 2012-08-22

Locations

28 sites across 2 countries: United States, Australia