A Multi-center Study to Evaluate the Safety and Efficacy of PEP005 (Ingenol Mebutate) Gel, When Used to Treat Actinic Keratoses on Non-head Locations (Trunk and Extremities)

Peplin

Status and phase: Completed; Phase 3

Conditions: Actinic Keratosis

Treatments: Drug: PEP005 Gel

Study type: Interventional

Funder types: Industry

Identifiers

NCT00917306

PEP005-020

Details and patient eligibility

About

The open label study is designed to assess the safety and efficacy of 0.05% PEP005 Gel when applied to an area of skin containing 4-8 AK lesions on non-head locations.

Enrollment: 102 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Patient is male or female and at least 18 years of age.

• Female patient must be of either:

  • Non-childbearing potential, post-menopausal, or there is a confirmed clinical history of sterility (e.g., the patient is without a uterus)
  • Childbearing potential, provided there are negative urine pregnancy test results prior to study treatment, to rule out pregnancy

Exclusion Criteria

• Cosmetic or therapeutic procedures within two weeks and within 2 cm of the selected treatment area.
• Treatment with immunomodulators, interferon/ interferon inducers or systemic medications that suppress the immune system within 4 weeks.
• Treatment with 5-FU, imiquimod, diclofenac, or photodynamic therapy: within 8 weeks and 2 cm of the selected treatment area.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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102 participants in 1 patient group

PEP005 gel

Experimental group

Description:

PEP005 gel, 0.05% administered once daily for 2 consecutive days

Treatment:

Drug: PEP005 Gel