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

Peplin

Status and phase: Completed; Phase 2

Conditions: Actinic Keratosis

Treatments: Drug: PEP005

Study type: Interventional

Funder types: Industry

Identifiers

NCT00107965

2005/145

PEP005-001

Details and patient eligibility

About

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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 8 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: PEP005

Drug: PEP005

Drug: PEP005

Drug: PEP005

Drug: PEP005

Drug: PEP005

Drug: PEP005

Drug: PEP005

2

Experimental group

Treatment:

Drug: PEP005

Drug: PEP005

Drug: PEP005

Drug: PEP005

Drug: PEP005

Drug: PEP005

Drug: PEP005

Drug: PEP005

3

Experimental group

Treatment:

Drug: PEP005

Drug: PEP005

Drug: PEP005

Drug: PEP005

Drug: PEP005

Drug: PEP005

Drug: PEP005

Drug: PEP005

4

Placebo Comparator group

Treatment:

Drug: PEP005

Drug: PEP005

Drug: PEP005

Drug: PEP005

Drug: PEP005

Drug: PEP005

Drug: PEP005

Drug: PEP005

5

Experimental group

Treatment:

Drug: PEP005

Drug: PEP005

Drug: PEP005

Drug: PEP005

Drug: PEP005

Drug: PEP005

Drug: PEP005

Drug: PEP005

6

Experimental group

Treatment:

Drug: PEP005

Drug: PEP005

Drug: PEP005

Drug: PEP005

Drug: PEP005

Drug: PEP005

Drug: PEP005

Drug: PEP005

7

Experimental group

Treatment:

Drug: PEP005

Drug: PEP005

Drug: PEP005

Drug: PEP005

Drug: PEP005

Drug: PEP005

Drug: PEP005

Drug: PEP005

8

Placebo Comparator group

Treatment:

Drug: PEP005

Drug: PEP005

Drug: PEP005

Drug: PEP005

Drug: PEP005

Drug: PEP005

Drug: PEP005

Drug: PEP005