A Multicenter Study to Evaluate the Safety and Efficacy of PEP005 Topical Gel When Used to Treat Actinic Keratoses on the Head (Face or Scalp)

Peplin

Status and phase: Completed; Phase 2

Conditions: Actinic Keratosis

Treatments: Drug: PEP005 Topical Gel; Drug: Vehicle gel

Study type: Interventional

Funder types: Industry

Identifiers

NCT00700063

PEP005-015

Details and patient eligibility

About

This Phase IIb study is designed to assess the safety and efficacy of 0.005%, 0.01% and 0.015% PEP005 Topical Gel when applied to an area of skin, containing 4-8 AK lesions on the face or scalp.

Enrollment: 265 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Must be male or female
• Female patients must be of
• Non-childbearing potential;
• Childbearing potential, provided negative pregnancy test and using effective contraception
• 4 to 8 AK lesions on the face or scalp

Exclusion criteria

• Cosmetic or therapeutic procedures within 2 weeks and within 2 cm 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 treatment area

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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265 participants in 8 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: PEP005 Topical Gel

Drug: PEP005 Topical Gel

Drug: PEP005 Topical Gel

Drug: PEP005 Topical Gel

Drug: PEP005 Topical Gel

Drug: PEP005 Topical Gel

2

Experimental group

Treatment:

Drug: PEP005 Topical Gel

Drug: PEP005 Topical Gel

Drug: PEP005 Topical Gel

Drug: PEP005 Topical Gel

Drug: PEP005 Topical Gel

Drug: PEP005 Topical Gel

3

Experimental group

Treatment:

Drug: PEP005 Topical Gel

Drug: PEP005 Topical Gel

Drug: PEP005 Topical Gel

Drug: PEP005 Topical Gel

Drug: PEP005 Topical Gel

Drug: PEP005 Topical Gel

4

Placebo Comparator group

Treatment:

Drug: Vehicle gel

Drug: Vehicle gel

5

Experimental group

Treatment:

Drug: PEP005 Topical Gel

Drug: PEP005 Topical Gel

Drug: PEP005 Topical Gel

Drug: PEP005 Topical Gel

Drug: PEP005 Topical Gel

Drug: PEP005 Topical Gel

6

Experimental group

Treatment:

Drug: PEP005 Topical Gel

Drug: PEP005 Topical Gel

Drug: PEP005 Topical Gel

Drug: PEP005 Topical Gel

Drug: PEP005 Topical Gel

Drug: PEP005 Topical Gel

7

Experimental group

Treatment:

Drug: PEP005 Topical Gel

Drug: PEP005 Topical Gel

Drug: PEP005 Topical Gel

Drug: PEP005 Topical Gel

Drug: PEP005 Topical Gel

Drug: PEP005 Topical Gel

8

Placebo Comparator group

Treatment:

Drug: Vehicle gel

Drug: Vehicle gel