Twelve Month Follow-Up of CP0108
Twelve Month Follow-Up Evaluation of Subjects Participating in DUSA-CP0108 (A Phase 3 Study of Photodynamic Therapy With Levulan Kerastick Topical Solution + Blue Light Versus Topical Solution Vehicle + Blue Light for the Treatment of Actinic Keratoses on the Upper Extremities)
1 other identifier
observational
206
1 country
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2014
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2014
CompletedFirst Submitted
Initial submission to the registry
August 4, 2014
CompletedFirst Posted
Study publicly available on registry
August 5, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2016
CompletedSeptember 23, 2016
September 1, 2016
1.5 years
August 4, 2014
September 22, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Subject Recurrence Rate
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
Month 12
Duration of Response
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.
one year
Lesion Recurrence Rate
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.
Month 12
Duration of Lesion Response
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.
one year
Other Outcomes (35)
Hyperpigmentation
Baseline
Hyperpigmentation
Month 3
Hyperpigmentation
Month 6
- +32 more other outcomes
Study Arms (2)
ALA
Subjects who received ALA in CP0108
Vehicle
Subjects who received Vehicle in CP0108
Interventions
Eligibility Criteria
Subjects who were enrolled in the DUSA-CP0108 study, completed their assigned treatment (ALA-PDT or vehicle + blue-light) and Visit 6.
You may qualify if:
- Subject must have been enrolled in the DUSA-CP0108 study, completed their assigned treatment and Visit 6 (Week 12).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Center For Dermatology Clinical Research, Inc.
Fremont, California, 94538, United States
UCSD Dermatology
San Diego, California, 92122, United States
Center for Clinical and Cosmetic Research
Aventura, Florida, 33180, United States
MOORE Clinical Research, Inc
Brandon, Florida, 33609, United States
Spencer Clinical Services
St. Petersburg, Florida, 33716, United States
Altman Dermatology Associates
Arlington Heights, Illinois, 60005, United States
Shideler Clinical Research Center
Carmel, Indiana, 46032, United States
The Indiana Clinical Trials Center, PC
Plainfield, Indiana, 46168, United States
Minnesota Clinical Study Center
Fridley, Minnesota, 55432, United States
Oregon Dermatology and Research Center
Portland, Oregon, 97210, United States
J&S Studies, Inc
College Station, Texas, 77845, United States
Suzanne Bruce and Associates, P.A.,The Center for Skin Research
Houston, Texas, 77056, United States
Virginia Clinical Research, Inc.
Norfolk, Virginia, 23507, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Stuart Marcus, MD, PhD
DUSA Pharmaceuticals, Inc.
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 4, 2014
First Posted
August 5, 2014
Study Start
August 1, 2014
Primary Completion
February 1, 2016
Study Completion
April 1, 2016
Last Updated
September 23, 2016
Record last verified: 2016-09