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NCT00915551 Clinical Trial

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)

Actinic Keratosis Clinical Trial

Official title:
A Multi-center, Randomized, Parallel Group, Double-blind, Vehicle-controlled Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel, 0.015% In Patients With Actinic Keratoses ON the Head (Face or Scalp) (REGION-IIb)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00915551
Other study ID # PEP005-025
Secondary ID
Status Completed
Phase Phase 3
First received June 4, 2009
Last updated February 18, 2015
Start date June 2009
Est. completion date September 2009

Study information
Verified date November 2013
Source Peplin
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationAustralia: Department of Health and Ageing Therapeutic Goods Administration
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 278
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 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• PEP005 (Ingenol Mebutate) gel, 0.015%
once daily for 3 consecutive days
• Vehicle Gel
once daily for 3 consecutive days

Locations
Country Name City State
Australia The Skin Centre Benowa Queensland
Australia South East Dermatology, Belmont Specialist Centre Carina Heights Queensland
United States Academic Dermatology Associates Albuquerque New Mexico
United States Altman Dermatology Associates Arlington Heights Illinois
United States DermResearch, Inc. Austin Texas
United States Laser Skin Surgery Center of Indiana Carmel Indiana
United States Dermatology, Laser Vein Specialists of the Carolinas Charlotte North Carolina
United States Deaconess Clinic, Inc Evansville Indiana
United States Center for Dermatology Fremont California
United States Karl G. Heine Dermatology Henderson Nevada
United States Burke Pharmaceutical Research Hot Springs Arizona
United States Suzanne Bruce and Associates, PA, The Center for Skin Research Houston Texas
United States North Florida Dermatology Associates, PA Jacksonville Florida
United States The Education and Research Foundation Lynchburg Virginia
United States Mount Sinai School of Medicine New York New York
United States Skin Specialists, PC Omaha Nebraska
United States The Indiana Clinical Trials Center, PC Plainfield Indiana
United States Oregon Medical Research Center, PC Portland Oregon
United States Dermatology Associates of Rochester, PC Rochester New York
United States Progressive Clinical Research San Antonio Texas
United States Premier Clinical Research Spokane Washington

Sponsors (1)
Lead Sponsor Collaborator
Peplin

Countries where clinical trial is conducted

United States,  Australia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Complete Clearance of Actinic Keratoses (AK) Lesions Complete clearance of the treatment field baseline and 57 days No
Secondary Partial Clearance of Actinic Keratoses (AK) Partial clearance defined as = 75% reduction in the number of AK lesions identified at baseline in the treatment area baseline and 57 days No
See also
  Status Clinical Trial Phase
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Completed NCT02674048 - Metvix Daylight PDT in Actinic Keratosis
Completed NCT02421471 - PMS to Evaluate the Safety and Efficacy of Picato® Gel
Completed NCT02239679 - Controlled Study of the Occurrence of Actinic Keratosis on the Face After Cryotherapy + Aminolevulinic Acid (ALA) Photodynamic Therapy Phase 2
Completed NCT01686152 - Study Comparing Imiquimod Cream, 3.75% to Zyclara® (Imiquimod) Cream, 3.75% in the Treatment of Actinic Keratosis Phase 3
Completed NCT01444989 - Development and Validation of a Quality of Life Instrument for Actinic Keratosis N/A
Completed NCT01449513 - PEP005 Gel - Biological Effects in Actinic Keratosis Assessed by Reflectance Confocal Microscopy Phase 1
Terminated NCT01525329 - Combination Therapy With 5-Fluorouracil and Photodynamic Therapy in Post-transplant Premalignant Skin Disease Phase 3
Terminated NCT01203878 - Treatment of Actinic Keratoses of the Face With Imiquimod 3.75% Cream Followed by Photodynamic Therapy Phase 4
Completed NCT00989313 - A Long Term Follow up Study of Patients Who Have Complete Clearance of Their Actinic Keratosis (AK) Lesions at the Day 57 Visit in the PEP005-028 Study Phase 3
Completed NCT00306800 - Metvix PDT Versus Vehicle PDT With Aktilite CL128 Lamp in Patients With Actinic Keratosis on the Face and Scalp Phase 3
Completed NCT00375739 - Study to Determine the Safety of PEP005 0.025% and 0.05% Topical Gel in Patients With Actinic Keratoses Phase 2
Completed NCT03285490 - A Multi-Center Study to Evaluate the Efficacy and Safety of KX2-391 Ointment 1% on Actinic Keratosis on Face or Scalp (AK004) Phase 3
Completed NCT03319251 - Biomarker Database Registry for Photodynamic Therapy
Completed NCT02866695 - Safety and Efficacy of Ingenol Mebutate Gel 0.015% for Treatment of AK on the Face in Solid Organ Transplant Recipients Phase 4
Completed NCT02952898 - Study Comparing GDC 695 and Diclofenac Sodium Gel, 3% in Subjects With Actinic Keratoses Phase 3
Completed NCT02984072 - Menthol for PDT Pain Relief Phase 4
Recruiting NCT03684772 - Topical Ionic Contra-Viral Therapy in Actinic Keratosis Phase 2
Completed NCT02902822 - Tele-dermatology of Skin Cancer in a Cohort of Local Health Authority Employees in the Province of Bergamo N/A
Completed NCT02878382 - Potential Impact of Patient Vitamin D Status in AK Response to MAL-PDT N/A

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