Twelve Month Follow-Up of CP0108
- Conditions
- Actinic Keratosis
- Interventions
- Drug: Aminolevulinic Acid (ALA)Drug: Topical Solution VehicleDevice: BLU-U Blue Light Photodynamic Therapy Illuminator
- Registration Number
- NCT02209012
- Lead Sponsor
- DUSA Pharmaceuticals, Inc.
- Brief Summary
The purpose of this study is to determine the long-term safety and efficacy of Levulan PDT in subjects with multiple actinic keratosis of the upper extremities who received treatment as part of the DUSA CP0108 study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 206
- Subject must have been enrolled in the DUSA-CP0108 study, completed their assigned treatment and Visit 6 (Week 12).
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description ALA Aminolevulinic Acid (ALA) Subjects who received ALA in CP0108 ALA BLU-U Blue Light Photodynamic Therapy Illuminator Subjects who received ALA in CP0108 Vehicle Topical Solution Vehicle Subjects who received Vehicle in CP0108 Vehicle BLU-U Blue Light Photodynamic Therapy Illuminator Subjects who received Vehicle in CP0108
- Primary Outcome Measures
Name Time Method Duration of Response one year the time from Week 12 (in the DUSA-CP0108 study) to the visit at which a previously treated and cleared lesion recurs. If a subject begins or receives treatment for previously cleared AK lesions in the Treatment Area between scheduled visits, the date the treatment started will be the end of treatment response, or, if the start date is unknown, the visit prior to starting the new treatment will be the end of treatment response.
Lesion Recurrence Rate Month 12 the proportion of lesions that were CR at Week 12 in CP0108 that are visible or palpable at Visit 10, will be determined for all ALA-PDT treated subjects who have at least one AK designated as "clear" at Week 12 in the DUSA-CP0108 study.
Subject Recurrence Rate Month 12 percentage of subjects who had achieved 100% clearance at Visit 6 (Week 12) in CP0108, that have one or more previously treated (as part of CP0108) AK lesion(s) present in the Treatment Area at any visit during CP0108A follow-up
Duration of Lesion Response one year the time from Week 12 (in the DUSA-CP0108 study) to the visit at which the AK lesion recurs for all ALA-PDT treated subjects who have at least one AK designated as "clear" at Week 12 in the DUSA-CP0108 study. If a previously cleared lesion receives treatment between scheduled visits, the date the treatment started will be the end of treatment response for that lesion, or, if the start date is unknown, the visit prior to starting the new treatment will be the end of treatment response.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (13)
Virginia Clinical Research, Inc.
🇺🇸Norfolk, Virginia, United States
Shideler Clinical Research Center
🇺🇸Carmel, Indiana, United States
Center For Dermatology Clinical Research, Inc.
🇺🇸Fremont, California, United States
Altman Dermatology Associates
🇺🇸Arlington Heights, Illinois, United States
UCSD Dermatology
🇺🇸San Diego, California, United States
Center for Clinical and Cosmetic Research
🇺🇸Aventura, Florida, United States
MOORE Clinical Research, Inc
🇺🇸Brandon, Florida, United States
Minnesota Clinical Study Center
🇺🇸Fridley, Minnesota, United States
Suzanne Bruce and Associates, P.A.,The Center for Skin Research
🇺🇸Houston, Texas, United States
The Indiana Clinical Trials Center, PC
🇺🇸Plainfield, Indiana, United States
Oregon Dermatology and Research Center
🇺🇸Portland, Oregon, United States
J&S Studies, Inc
🇺🇸College Station, Texas, United States
Spencer Clinical Services
🇺🇸St. Petersburg, Florida, United States