Study to Determine the Safety of Two Applications of PEP005 Topical Gel to Actinic Keratoses

Actinic Keratosis Clinical Trial

Official title:

A Multi-center, Randomized, Double-blind, Parallel-group, Vehicle-controlled Study to Determine the Safety of PEP005 0.0025%, 0.01% and 0.05% Gel With Two Treatment Schedules, Day 1 & 2 or Day 1 & 8 Applications to Actinic Keratoses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00107965
• Other study ID #: PEP005-001
• Secondary ID: 2005/145
• Status: Completed
• Phase: Phase 2
• First received: April 11, 2005
• Last updated: March 24, 2015
• Start date: March 2005
• Est. completion date: September 2005

Study information

• Verified date: March 2015
• Source: Peplin
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether topical application of PEP005 is safe for the treatment of actinic keratoses.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2005
• Est. primary completion date: September 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or female patients

• At least five individual AK lesions on the arms, shoulders, chest, face and/or scalp

Exclusion Criteria:

• A cosmetic or therapeutic procedure:

• within 10 cm of the selected AK lesions during the 3 months prior to study entry or

• anywhere during the 4 weeks prior to study entry or anticipated treatment during the study

• Treatment with 5-fluorouracil, imiquimod, diclofenac or photodynamic therapy:

• of lesions located within 10 cm of the selected AK lesions during the 3 months prior to study entry or

• anywhere during the 4 weeks prior to study entry or anticipated treatment during the study

• Use of acid-containing products, topical retinoids or light chemical peels within 10 cm of the selected AK lesions during the 3 months prior to study entry, or anticipated treatment in this same area during the study

• Treatment with immuno-modulators, cytotoxic drugs, or interferon/interferon inducers during the 4 weeks prior to study entry or anticipated treatment during the study

• Treatment with psoralen plus UVA or use of UVB therapy during the 6 months prior to study entry or anticipated treatment during the study

• Use of systemic retinoids during the 6 months prior to study entry or anticipated treatment during the study

• Anticipated excessive or prolonged exposure to ultraviolet light or use of topical salves, creams or ointments to the selected AK lesions during the study

• Females of childbearing potential

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Actinic Keratosis
• Keratosis
• Keratosis, Actinic

Intervention

Drug:
• PEP005
0.0025% PEP005 Topical Gel (Day 1,2 application)
• PEP005
0.01% PEP005 Topical Gel (Day 1,2 application)
• PEP005
0.05% PEP005 Topical Gel (Day 1,2 application)
• PEP005
Vehicle Gel (Day 1,2 application)
• PEP005
0.0025% PEP005 Topical Gel (Day 1,8 application)
• PEP005
0.01% PEP005 Topical Gel (Day 1,8 application)
• PEP005
0.05% PEP005 Topical Gel (Day 1,8 application)
• PEP005
Vehicle Gel (Day 1,8 application)

Locations

Country	Name	City	State
Australia	Siller Medical	Brisbane	Queensland
Australia	Fremantle Dermatology	Fremantle	Western Australia
Australia	Private Dermaology Clinic	Fremantle	Western Australia
Australia	Monash Medical Centre	Melbourne	Victoria
Australia	Skin and Cancer Foundation	Melbourne	Victoria
Australia	Royal Prince Alfred Hospital	Sydney	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
Peplin

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the safety of PEP005 Topical Gel at 0.0025%, 0.01%, and 0.05% administered as two applications to patients with actinic keratosis (AKs) on the arms, shoulders, chest, face, and/or scalp		85 days	Yes
Secondary	To evaluate the efficacy of PEP005 0.0025%, 0.01% and 0.05% Topical Gel in treating Actinic Keratoses		85 days	No

External Links

•   Clinical Trials at LEO Pharma