A Multi-Center Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel, When Used to Treat Actinic Keratoses on the Head (Face or Scalp)

Peplin

Status and phase: Completed; Phase 3

Conditions: Actinic Keratosis

Treatments: Drug: Vehicle Gel; Drug: PEP005 (Ingenol Mebutate) gel, 0.015%

Study type: Interventional

Funder types: Industry

Identifiers

NCT00915551

PEP005-025

Details and patient eligibility

About

This Phase III study is designed to assess the efficacy and safety of PEP005 Gel, 0.015% when applied to an area of skin containing 4-8 AK lesions on the face or scalp.

Enrollment: 278 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

• Female patients must be of either:

  • Non-childbearing potential, post-menopausal
  • Childbearing potential, provided there are negative serum and urine pregnancy test results prior to study treatment, to rule out pregnancy

Exclusion criteria

• Cosmetic or therapeutic procedures within 2 weeks and 2cm of the selected treatment area
• Treatment with immunomodulators, or 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: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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278 participants in 2 patient groups, including a placebo group

PEP005 (Ingenol Mebutate) gel

Experimental group

Treatment:

Drug: PEP005 (Ingenol Mebutate) gel, 0.015%

Vehicle gel

Placebo Comparator group

Treatment:

Drug: Vehicle Gel