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NCT00916006 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-IIa)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00916006
Other study ID # PEP005-016
Secondary ID
Status Completed
Phase Phase 3
First received June 4, 2009
Last updated March 13, 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: 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 269
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 Gel
0.015%, three day treatment
• Vehicle gel
Vehicle gel, three day treatment

Locations
Country Name City State
Australia Southderm Pty Ltd Kogarah New South Wales
Australia St George Dematology and Skin Cancer Centre Kogarah New South Wales
United States Atlanta Dermatology, Vein & Research Center, LLC Alpharetta Georgia
United States Glazer Dermatology Buffalo Grove Illinois
United States J & S Studies, Inc. College Station Texas
United States Hamzavi Dermatology Fort Gratiot Michigan
United States Minnesota Clinical Study Center Fridley Minnesota
United States Dawes Fretein Clinical Research Group, LLC Indianapolis Indiana
United States Dermatology Research Associates Los Angeles California
United States University of Miami, Skin Research Camp Miami Florida
United States Dermatology Research Associates Nashville Tennessee
United States Medaphase Inc Newnan Georgia
United States Virginia Clinical Research, Inc Norfolk Virginia
United States Dermatology Specialists Inc Oceanside California
United States Pedia Research LLC Owensboro Kentucky
United States Wake Research Associates Raleigh North Carolina
United States Dermatology Research Center, Inc. Salt Lake City Utah
United States Skin Surgery Medical Group Inc. San Diego California
United States Conant Medical Group San Francisco California
United States Dermatology Associates of Tyler Tyler Texas
United States Center for Clinical Studies Webster Texas

Sponsors (1)
Lead Sponsor Collaborator
Peplin

Countries where clinical trial is conducted

United States,  Australia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Patients With Complete Clearance of Actinic Keratosis (AK) Lesions. Complete clearance rate of actinic keratosis (AK) lesions, defined as the proportion of patients with no clinically visible AK lesions in the selected treatment area. 57 days No
Secondary Patients With Partial Clearance of Actinic Keratosis (AK) Patients with partial clearance defined as = 75% reduction in the number of actinic keratosis (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 NCT02239679 - Controlled Study of the Occurrence of Actinic Keratosis on the Face After Cryotherapy + Aminolevulinic Acid (ALA) Photodynamic Therapy Phase 2
Completed NCT02421471 - PMS to Evaluate the Safety and Efficacy of Picato® Gel
Completed NCT01686152 - Study Comparing Imiquimod Cream, 3.75% to Zyclara® (Imiquimod) Cream, 3.75% in the Treatment of Actinic Keratosis Phase 3
Terminated NCT01525329 - Combination Therapy With 5-Fluorouracil and Photodynamic Therapy in Post-transplant Premalignant Skin Disease 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 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 NCT02938715 - Pilot Study of the Pragmatic Use of Mobile Phone Based Follow up of Actinic Keratoses Treated With Topical 5-fluorouracil N/A
Completed NCT02878382 - Potential Impact of Patient Vitamin D Status in AK Response to MAL-PDT N/A

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