Clinical trial NCT02209012: Twelve Month Follow-Up of CP0108
Official title: 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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Actinic Keratosis
Keywords: Actinic Keratosis
Lead sponsor: DUSA Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2014-08-05
Enrollment: 206
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who were enrolled in the DUSA-CP0108 study, completed their assigned treatment (ALA-PDT or vehicle + blue-light) and Visit 6.

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.


Eligibility criteria: Inclusion Criteria:

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

Primary outcomes:
measure: Subject Recurrence Rate
timeFrame: Month 12
measure: Duration of Response
timeFrame: one year
measure: Lesion Recurrence Rate
timeFrame: Month 12
measure: Duration of Lesion Response
timeFrame: one year
Secondary outcomes:
Other outcomes:
measure: Hyperpigmentation
timeFrame: Baseline
measure: Hyperpigmentation
timeFrame: Month 3
measure: Hyperpigmentation
timeFrame: Month 6
measure: Hyperpigmentation
timeFrame: Month 9
measure: Hyperpigmentation
timeFrame: Month 12
measure: Hypopigmentation
timeFrame: Baseline
measure: Hypopigmentation
timeFrame: Month 3
measure: Hypopigmentation
timeFrame: Month 6
measure: Hypopigmentation
timeFrame: Month 9
measure: Hypopigmentation
timeFrame: Month 12
measure: Erythema
timeFrame: Baseline
measure: Erythema
timeFrame: Month 3
measure: Erythema
timeFrame: Month 6
measure: Erythema
timeFrame: Month 9
measure: Erythema
timeFrame: Month 12
measure: Edema
timeFrame: Baseline
measure: Edema
timeFrame: Month 3
measure: Edema
timeFrame: Month 6
measure: Edema
timeFrame: Month 9
measure: Edema
timeFrame: Month 12
measure: Stinging/Burning
timeFrame: Baseline
measure: Stinging/Burning
timeFrame: Month 3
measure: Stinging/Burning
timeFrame: Month 6
measure: Stinging/Burning
timeFrame: Month 9
measure: Stinging/Burning
timeFrame: Month 12
measure: Scaling & Dryness
timeFrame: Baseline
measure: Scaling & Dryness
timeFrame: Month 3
measure: Scaling & Dryness
timeFrame: Month 6
measure: Scaling & Dryness
timeFrame: Month 9
measure: Scaling & Dryness
timeFrame: Month 12
measure: Oozing/Vesiculation/Crusting
timeFrame: Baseline
measure: Oozing/Vesiculation/Crusting
timeFrame: Month 3
measure: Oozing/Vesiculation/Crusting
timeFrame: Month 6
measure: Oozing/Vesiculation/Crusting
timeFrame: Month 9
measure: Oozing/Vesiculation/Crusting
timeFrame: Month 12
Locations:
city: Fremont
country: United States
facility: Center For Dermatology Clinical Research, Inc.
state: California
city: San Diego
country: United States
facility: UCSD Dermatology
state: California
city: Aventura
country: United States
facility: Center for Clinical and Cosmetic Research
state: Florida
city: Brandon
country: United States
facility: MOORE Clinical Research, Inc
state: Florida
city: St. Petersburg
country: United States
facility: Spencer Clinical Services
state: Florida
city: Arlington Heights
country: United States
facility: Altman Dermatology Associates
state: Illinois
city: Carmel
country: United States
facility: Shideler Clinical Research Center
state: Indiana
city: Plainfield
country: United States
facility: The Indiana Clinical Trials Center, PC
state: Indiana
city: Fridley
country: United States
facility: Minnesota Clinical Study Center
state: Minnesota
city: Portland
country: United States
facility: Oregon Dermatology and Research Center
state: Oregon
city: College Station
country: United States
facility: J&S Studies, Inc
state: Texas
city: Houston
country: United States
facility: Suzanne Bruce and Associates, P.A.,The Center for Skin Research
state: Texas
city: Norfolk
country: United States
facility: Virginia Clinical Research, Inc.
state: Virginia
Study officials:
affiliation: DUSA Pharmaceuticals, Inc.
name: Stuart Marcus, MD, PhD
role: STUDY_DIRECTOR
References: