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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:
ClinicalTrials.gov Identifier:
NCT00107965
First Posted: April 12, 2005
Last Update Posted: March 25, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Peplin
  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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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:


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 ]

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 ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Responsible Party: Janelle Katsamas, Peplin
ClinicalTrials.gov Identifier: NCT00107965     History of Changes
Other Study ID Numbers: PEP005-001
2005/145
First Submitted: April 11, 2005
First Posted: April 12, 2005
Last Update Posted: March 25, 2015
Last Verified: March 2015

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

Additional relevant MeSH terms:
Keratosis
Keratosis, Actinic
Skin Diseases
Precancerous Conditions
Neoplasms