NCT00107965CompletedPhase 2
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
Peplin6 sites in 1 country60 target enrollmentStarted: March 2005Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 60
- Locations
- 6
- Primary Endpoint
- 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
Study Overview
Brief Summary
The purpose of this study is to determine whether topical application of PEP005 is safe for the treatment of actinic keratoses.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
1
Experimental
Intervention: PEP005 (Drug)
2
Experimental
Intervention: PEP005 (Drug)
3
Experimental
Intervention: PEP005 (Drug)
4
Placebo Comparator
Intervention: PEP005 (Drug)
5
Experimental
Intervention: PEP005 (Drug)
6
Experimental
Intervention: PEP005 (Drug)
7
Experimental
Intervention: PEP005 (Drug)
8
Placebo Comparator
Intervention: PEP005 (Drug)
Outcomes
Primary Outcomes
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 Outcomes
- To evaluate the efficacy of PEP005 0.0025%, 0.01% and 0.05% Topical Gel in treating Actinic Keratoses(85 days)
Investigators
Study Sites (6)
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