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NCT00953732 Clinical Trial

A Long Term Follow up Study of Patients Who Have Completed the PEP005-016 or PEP005-025 Studies

Actinic Keratosis Clinical Trial

Official title:
A 12 Month, Long-term Follow-up Study of Patients With Actinic Keratosis on the Head (Face or Scalp) Who Have Completed Day 57 in Studies PEP005-016 or PEP005-025 (REGION IIa and IIb)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00953732
Other study ID # PEP005-030
Secondary ID
Status Completed
Phase Phase 3
First received August 4, 2009
Last updated March 25, 2015
Start date August 2009
Est. completion date October 2010

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 Observational

Clinical Trial Summary

This study is designed to follow up patients who have achieved complete clearance of AK lesions at the Day 57 visit having completed the PEP005-016 or PEP005-025 studies over a 12 month period to assess both recurrence of Actinic Keratosis (AK) lesions and long term safety in the selected treatment area.

Description:

A 12 month long-term follow-up study of patients who have achieved complete clearance of AK lesions at the Day 57 in the Phase 3 studies PEP005-016 or PEP005-025.

Recruitment information / eligibility
Status Completed
Enrollment 117
Est. completion date October 2010
Est. primary completion date October 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patient must have achieved complete clearance of AK lesions (lesion count = 0) at Day 57 in one of the following Peplin AK clinical studies: PEP005-016 or PEP005-025

- Patient has provided informed consent documented by signing the Informed Consent Form (ICF) prior to any study-related procedures

Exclusion Criteria:

- Concurrent participation in another research study which would involve the selected treatment area (except for any post-study follow-up visits for previous Peplin AK study)

- Early termination from study PEP005-016 or PEP005-025

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• Lesion count
Lesion count in area treated by study drug in a prior study. No drug will be applied during this long-term follow up study. Drug was applied during the primary study.

Locations
Country Name City State
Australia The Skin Centre Benowa Queensland
Australia South East Dermatology, Belmont Specialist Centre Carina Heights Queensland
Australia Southderm Pty Ltd Kogarah New South Wales
Australia St George Dematology and Skin Cancer Centre Kogarah New South Wales
United States Academic Dermatology Associates Albuquerque New Mexico
United States Atlanta Dermatology, Vein & Research Center, LLC Alpharetta Georgia
United States Altman Dermatology Associates Arlington Heights Illinois
United States DermResearch, Inc. Austin Texas
United States Glazer Dermatology Buffalo Grove Illinois
United States Laser Skin Surgery Center of Indiana Carmel Indiana
United States Dermatology, Laser Vein Specialists of the Carolinas Charlotte North Carolina
United States J & S Studies, Inc. College Station Texas
United States Deaconess Clinic, Inc Evansville Indiana
United States Hamzavi Dermatology Fort Gratiot Michigan
United States Center for Dermatology Fremont California
United States Minnesota Clinical Study Center Fridley Minnesota
United States Karl G. Heine Dermatology Henderson Nevada
United States Burke Pharmaceutical Research Hot Springs Arizona
United States Suzanne Bruce and Associates, The Center for Skin Research Houston Texas
United States Dawes Fretein Clinical Research Group, LLC Indianapolis Indiana
United States North Florida Dermatology Associates, PA Jacksonville Florida
United States Dermatology Research Associates Los Angeles California
United States The Education and Research Foundation Lynchburg Virginia
United States University of Miami, Skin Research Camp Miami Florida
United States Dermatology Research Associates Nashville Tennessee
United States Mount Sinai School of Medicine New York New York
United States Medaphase Inc Newnan Georgia
United States Virginia Clinical Research, Inc Norfolk Virginia
United States Dermatology Specialists Inc Oceanside California
United States Skin Specialists, PC Omaha Nebraska
United States Pedia Research LLC Owensboro Kentucky
United States The Indiana Clinical Trials Center, PC Plainfield Indiana
United States Oregon Medical Research Portland Oregon
United States Wake Research Associates Raleigh North Carolina
United States Dermatology Associates of Rochester, PC Rochester New York
United States Dermatology Research Center, Inc. Salt Lake City Utah
United States Progressive Clinical Research San Antonio Texas
United States Skin Surgery Medical Group Inc. San Diego California
United States Conant Medical Group San Francisco California
United States Premier Clinical Research Spokane Washington
United States Dermatology Associates of Tyler Tyler Texas
United States Center for Clinical Studies Webster Texas

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 Summarize treatment area recurrence of AK lesions, in the selected treatment area 12 months No
Secondary Summarize long-term safety data(incidence of AEs in the treatment area) 12 months Yes
See also
  Status Clinical Trial Phase
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Completed NCT02674048 - Metvix Daylight PDT in Actinic Keratosis
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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 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
Completed NCT01444989 - Development and Validation of a Quality of Life Instrument for Actinic Keratosis N/A
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 NCT02878382 - Potential Impact of Patient Vitamin D Status in AK Response to MAL-PDT N/A
Completed NCT02902822 - Tele-dermatology of Skin Cancer in a Cohort of Local Health Authority Employees in the Province of Bergamo N/A

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