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)

NCT00917306 | Completed Phase 3

• 1 other identifier: PEP005-020
• Study Type: interventional
• Target: 102
• Locations: 2 countries
• Sites: 11

Brief Summary

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.

Conditions

Actinic Keratosis

Keywords

Peplin; Actinic keratosis; PEP005

Outcome Measures

Primary Outcomes (1)

• Safety (Incidence of treatment related AEs, local skin reactions and pigmentation and scarring)

  57 days

Secondary Outcomes (1)

• Efficacy (complete and partial clearance of AK lesions)

  57 days

Study Arms (1)

PEP005 gel

EXPERIMENTAL

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

Drug: PEP005 Gel

Interventions

PEP005 Gel DRUG

0.05% two day treatment

Also known as: PEP005

PEP005 gel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peplin: lead
• TKL Research, Inc.: collaborator

Study Sites (11)

Park Avenue Dermatology

Orange Park, Florida, 32073, United States

Location

Medaphase Inc

Newnan, Georgia, 30263, United States

Location

Gwinnett Clinical Research Centre

Snellville, Georgia, 30078-3250, United States

Location

Michigan Center for Research Corp

Clinton Twp, Michigan, 48038, United States

Location

Henry Ford Health Systems

Detroit, Michigan, 48202, United States

Location

Dermatology Associates of Rochester

Rochester, New York, 14623, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239-4501, United States

Location

Dermatology Research Associates

Nashville, Tennessee, 37203, United States

Location

Dematology on Ward

Adelaide, South Australia, 5006, Australia

Location

Dermatology Institute of Victoria

Melbourne, Victoria, 3141, Australia

Location

St John of God Dermatology

Subiaco, Western Australia, 6008, Australia

Location

Related Links

• Food and Drug Authority
• Therapeutic Goods Administration

MeSH Terms

Conditions

Keratosis, Actinic

Interventions

3-ingenyl angelate

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Eugene Bauer, MD

  Chief Medical Officer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2009
• First Posted: June 10, 2009
• Study Start: June 1, 2009
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: April 15, 2015

Record last verified: 2015-03

Locations

AU (3); US (8)