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NCT00742391 Clinical Trial

A Multicenter Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel When Used to Treat Actinic Keratoses (AKs) on the Non Head Locations

Actinic Keratoses 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, 0.05% In Patients With Actinic Keratoses ON Non-head Locations (REGION-I)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00742391
Other study ID # PEP005-014
Secondary ID
Status Completed
Phase Phase 3
First received August 25, 2008
Last updated February 18, 2015
Start date September 2008
Est. completion date February 2009

Study information
Verified date March 2012
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

The purpose of this study is to determine whether topical application of PEP005 is effective for the treatment of actinic keratoses.

Recruitment information / eligibility
Status Completed
Enrollment 255
Est. completion date February 2009
Est. primary completion date February 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Must be male or female and at least 18 years of age.

- Female patients must be of:

- Non-childbearing potential;

- Childbearing potential, provided negative serum and urine pregnancy test and using effective contraception.

- 4 to 8 AK lesions on non-head locations.

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

Study Design

Allocation: Randomized, Endpoint Classification: 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
two day treatment
• Vehicle gel
two day treatment

Locations
Country Name City State
Australia The Skin Centre Benowa Queensland
Australia Burswood Dermatology Victoria Park Western Australia
United States Academic Dermatology Associates Albuquerque New Mexico
United States University Hospitals Case Medical Center Cleveland Ohio
United States J & S Studies, Inc. College Station Texas
United States Colorado Medical Research Center Denver Colorado
United States Henry Ford Health Systems Detroit Michigan
United States Dermatology East Germantown Tennessee
United States Rivergate Dermatology and Skin Care Center Goodlettsville Tennessee
United States Advanced Dermatology and Cosmetic Research Kissimmee Florida
United States Omni Dermatology Research Mesa Arizona
United States Medaphase Inc Newnan Georgia
United States Park Avenue Dermatology Orange Park Florida
United States Advanced Dermatology & Cosmetic Surgery Ormond Beach Florida
United States Dermatology Center of Indiana/Indiana Clinical Trials Center Plainfield Indiana
United States Oregon Health and Science University Portland Oregon
United States Oregon Medical Research Portland Oregon
United States Dermatology Associates of Rochester Rochester New York
United States Gwinnett Clinical Research Centre Snellville Georgia
United States Karen S. Harkaway, MD. LLC South Delran New Jersey

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 (AKs) 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 (AKs) Partial clearance rate of AK lesions defined as the proportion of patients with a 75% or greater reduction in the number of actinic keratosis (AK) lesions identified at baseline in the selected treatment area. baseline and 57 days No
See also
  Status Clinical Trial Phase
Completed NCT03575780 - Single-Center Study Evaluating Systemic Exposure and Safety of KX2-391 Ointment 1% on the Face or Balding Scalp in Subjects With Actinic Keratosis Phase 1
Completed NCT04085367 - Multicenter Study to Assess the Efficacy and Safety of Methyl Aminolevulinate Hydrochloride (MAL) 16.8% Cream (CD06809-41) Versus Vehicle Cream for Actinic Keratosis of the Face Phase 3
Completed NCT05937529 - Impact of Madecassoside and 5 % Panthenol Cream in Post Photodynamic Therapy for Actinic Keratosis N/A
Completed NCT02520700 - A Comparison of White-light and Daylight Topical Methyl 5-aminolaevulinic Acid Photodynamic Therapy for Actinic Keratoses N/A
Terminated NCT01538901 - Imiquimod Versus Photodynamic Therapy of Actinic Keratoses in Organ Transplant Recipients Phase 4
Completed NCT01354717 - Bioequivalence Study of Generic Fluorouracil 0.5% Cream and 0.5% Carac® and Placebo Phase 3
Completed NCT03285477 - A Multi-Center Study to Evaluate the Efficacy and Safety of KX2-391 Ointment 1% on AK on Face or Scalp Phase 3
Suspended NCT03963102 - Duration of Ameluz Application in Acral Actinic Keratoses Response Phase 4
Not yet recruiting NCT05923060 - Imaging Techniques to Monitor Photosensitizer and sO2 Levels During Photodynamic Therapy of Actinic Keratoses Phase 2
Withdrawn NCT06026358 - Tirbanibulin 1% Ointment for the Treatment of Actinic Keratosis on the Back of the Hands Phase 4
Completed NCT02622594 - Bilateral Comparison of Treatment of Facial Actinic Keratoses Using Microneedling and Photodynamic Therapy With Aminolevulinic Acid and Blue Light Versus Photodynamic Therapy With Aminolevulinic Acid and Blue Light Using Two Incubation Times Phase 4
Completed NCT00774787 - Topical Imiquimod Cream in Combination With Cryotherapy for the Treatment of Actinic Keratoses Phase 4
Completed NCT00786994 - The Efficacy and Tolerability of Oleogel-S-10 in Patients With Actinic Keratoses Phase 2
Completed NCT00544258 - Pharmacokinetic Study to Evaluate the Extent of Systemic Absorption of PEP005 Phase 1
Completed NCT04024579 - Treatment of Actinic Keratosis With 5% KOH Solution
Completed NCT04843553 - Nicotinamide for Prevention of Pre-malignant Actinic Keratosis in Kidney Transplant Recipients Early Phase 1
Completed NCT03315286 - Validation of SHADE a Mobile Technology for Monitoring of Ultraviolet Exposure N/A
Completed NCT03279328 - Evaluating Skin Appearance Following 5-Flourouracil Cream for Treatment of Actinic Keratosis and the Effects of Topical Agents Phase 4
Completed NCT02062853 - Continuous Quality Improvement (CQI) Pilot Study Evaluating the Utility of an Educational Video N/A
Terminated NCT01532453 - Prevention of UV-induced Carcinogenic Skin Alterations in Immunosuppressed Solid Organ Transplanted Patients Phase 3

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