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)

Actinic Keratosis Clinical Trial

Official title:

A Multi-center, Open-label Study to Evaluate the Safety and Efficacy of PEP005 (Ingenol Mebutate) Gel, 0.05% in Patients With Actinic Keratoses on Non-head Locations (Trunk and Extremities)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00917306
• Other study ID #: PEP005-020
• Status: Completed
• Phase: Phase 3
• First received: June 8, 2009
• Last updated: March 25, 2015
• Start date: June 2009
• Est. completion date: September 2009

Study information

• Verified date: March 2015
• Source: Peplin
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationAustralia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Actinic Keratosis
• Keratosis
• Keratosis, Actinic

Intervention

Drug:
• PEP005 Gel
0.05% two day treatment

Locations

Country	Name	City	State
Australia	Dematology on Ward	Adelaide	South Australia
Australia	Dermatology Institute of Victoria	Melbourne	Victoria
Australia	St John of God Dermatology	Subiaco	Western Australia
United States	Michigan Center for Research Corp	Clinton Twp	Michigan
United States	Henry Ford Health Systems	Detroit	Michigan
United States	Dermatology Research Associates	Nashville	Tennessee
United States	Medaphase Inc	Newnan	Georgia
United States	Park Avenue Dermatology	Orange Park	Florida
United States	Oregon Health and Science University	Portland	Oregon
United States	Dermatology Associates of Rochester	Rochester	New York
United States	Gwinnett Clinical Research Centre	Snellville	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Peplin	TKL Research, Inc.

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety (Incidence of treatment related AEs, local skin reactions and pigmentation and scarring)		57 days	Yes
Secondary	Efficacy (complete and partial clearance of AK lesions)		57 days	No

External Links

•   Clinical Trials at LEO Pharma
•   Food and Drug Authority
•   Therapeutic Goods Administration