Clinical trial NCT00107965: Study to Determine the Safety of Two Applications of PEP005 Topical Gel to Actinic Keratoses
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Actinic Keratosis
Keywords: Actinic Keratosis
Solar Keratosis
AK
Sun spots
PEP005
Topical
Dermatology
Lead sponsor: Peplin
Sponsor class: INDUSTRY
First posted: 2005-04-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: 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
timeFrame: 85 days
Secondary outcomes:
measure: To evaluate the efficacy of PEP005 0.0025%, 0.01% and 0.05% Topical Gel in treating Actinic Keratoses
timeFrame: 85 days
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
city: Brisbane
country: Australia
facility: Siller Medical
state: Queensland
city: Melbourne
country: Australia
facility: Skin and Cancer Foundation
state: Victoria
city: Melbourne
country: Australia
facility: Monash Medical Centre
state: Victoria
city: Fremantle
country: Australia
facility: Fremantle Dermatology
state: Western Australia
city: Fremantle
country: Australia
facility: Private Dermaology Clinic
state: Western Australia
Study officials:
name: Greg Siller
role: PRINCIPAL_INVESTIGATOR
References: