Twelve Month Follow-Up of CP0108

N/ACompletedNCT02209012

DUSA Pharmaceuticals, Inc.206 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

206

Conditions

Actinic Keratosis

Interventions

Aminolevulinic Acid (ALA)DRUG

Levulan PDT given in CP0108

Topical Solution VehicleDRUG

Vehicle PDT given in CP0108

BLU-U Blue Light Photodynamic Therapy IlluminatorDEVICE

PDT given in CP0108

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subject must have been enrolled in the DUSA-CP0108 study, completed their assigned treatment and Visit 6 (Week 12).

Locations (13)

Center For Dermatology Clinical Research, Inc.

Fremont, California, United States

UCSD Dermatology

San Diego, California, United States

Center for Clinical and Cosmetic Research

Aventura, Florida, United States

Outcomes

Primary Outcomes

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

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: one year

Data from ClinicalTrials.gov

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