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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Actinic Keratosis

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome 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

Outcome Time Frame:

85 days

Safety Issue:

Yes

Principal Investigator

Greg Siller

Investigator Role:

Principal Investigator

Authority:

Australia: Department of Health and Ageing Therapeutic Goods Administration

Study ID:

PEP005-001

NCT ID:

NCT00107965

Start Date:

March 2005

Completion Date:

September 2005

Related Keywords:

  • Actinic Keratosis
  • Actinic Keratosis
  • Solar Keratosis
  • AK
  • Sun spots
  • PEP005
  • Topical
  • Dermatology
  • Keratosis
  • Keratosis, Actinic
  • Ichthyosis
  • Keratoacanthoma

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