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

This study has been completed.
Sponsor:
Information provided by:
Peplin
ClinicalTrials.gov Identifier:
NCT00107965
First received: April 11, 2005
Last updated: April 16, 2009
Last verified: April 2009
History of Changes
  Purpose

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


Condition Intervention Phase
Actinic Keratosis
 Drug: PEP005
 Phase 2

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Peplin:

Primary Outcome Measures:
  • 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 [ Time Frame: 85 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To evaluate the efficacy of PEP005 0.0025%, 0.01% and 0.05% Topical Gel in treating Actinic Keratoses [ Time Frame: 85 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: March 2005
Study Completion Date: September 2005
Primary Completion Date: September 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: PEP005
0.0025% PEP005 Topical Gel (Day 1,2 application)
Experimental: 2 Drug: PEP005
0.01% PEP005 Topical Gel (Day 1,2 application)
Experimental: 3 Drug: PEP005
0.05% PEP005 Topical Gel (Day 1,2 application)
Placebo Comparator: 4 Drug: PEP005
Vehicle Gel (Day 1,2 application)
Experimental: 5 Drug: PEP005
0.0025% PEP005 Topical Gel (Day 1,8 application)
Experimental: 6 Drug: PEP005
0.01% PEP005 Topical Gel (Day 1,8 application)
Experimental: 7 Drug: PEP005
0.05% PEP005 Topical Gel (Day 1,8 application)
Placebo Comparator: 8 Drug: PEP005
Vehicle Gel (Day 1,8 application)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00107965

Locations
Australia, New South Wales
Royal Prince Alfred Hospital
Sydney, New South Wales, Australia, 2050
Australia, Queensland
Siller Medical
Brisbane, Queensland, Australia, 4000
Australia, Victoria
Skin and Cancer Foundation
Melbourne, Victoria, Australia, 3052
Monash Medical Centre
Melbourne, Victoria, Australia, 3168
Australia, Western Australia
Fremantle Dermatology
Fremantle, Western Australia, Australia, 6160
Private Dermaology Clinic
Fremantle, Western Australia, Australia, 6160
Sponsors and Collaborators
Peplin
Investigators
Principal Investigator: Greg Siller
  More Information

No publications provided

Responsible Party: Janelle Katsamas, Peplin
ClinicalTrials.gov Identifier: NCT00107965     History of Changes
Other Study ID Numbers: PEP005-001, 2005/145
Study First Received: April 11, 2005
Last Updated: April 16, 2009
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Peplin:
Actinic Keratosis
Solar Keratosis
AK
Sun spots
 PEP005
Topical
Dermatology

Additional relevant MeSH terms:
Keratosis
Keratosis, Actinic
Ichthyosis
Keratoacanthoma
Skin Diseases
 Precancerous Conditions
Neoplasms
Skin Abnormalities
Congenital Abnormalities
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on May 16, 2013