Twelve Month Follow-Up of CP0108

NCT ID: NCT02209012

Last Updated: 2016-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

206 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-08-31

Study Completion Date

2016-04-30

Brief Summary

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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

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Conditions

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Actinic Keratosis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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ALA

Subjects who received ALA in CP0108

Aminolevulinic Acid (ALA)

Intervention Type DRUG

Levulan PDT given in CP0108

BLU-U Blue Light Photodynamic Therapy Illuminator

Intervention Type DEVICE

PDT given in CP0108

Vehicle

Subjects who received Vehicle in CP0108

Topical Solution Vehicle

Intervention Type DRUG

Vehicle PDT given in CP0108

BLU-U Blue Light Photodynamic Therapy Illuminator

Intervention Type DEVICE

PDT given in CP0108

Interventions

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Aminolevulinic Acid (ALA)

Levulan PDT given in CP0108

Intervention Type DRUG

Topical Solution Vehicle

Vehicle PDT given in CP0108

Intervention Type DRUG

BLU-U Blue Light Photodynamic Therapy Illuminator

PDT given in CP0108

Intervention Type DEVICE

Other Intervention Names

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Levulan Kerastick

Eligibility Criteria

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Inclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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DUSA Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stuart Marcus, MD, PhD

Role: STUDY_DIRECTOR

DUSA Pharmaceuticals, Inc.

Locations

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Center For Dermatology Clinical Research, Inc.

Fremont, California, United States

Site Status

UCSD Dermatology

San Diego, California, United States

Site Status

Center for Clinical and Cosmetic Research

Aventura, Florida, United States

Site Status

MOORE Clinical Research, Inc

Brandon, Florida, United States

Site Status

Spencer Clinical Services

St. Petersburg, Florida, United States

Site Status

Altman Dermatology Associates

Arlington Heights, Illinois, United States

Site Status

Shideler Clinical Research Center

Carmel, Indiana, United States

Site Status

The Indiana Clinical Trials Center, PC

Plainfield, Indiana, United States

Site Status

Minnesota Clinical Study Center

Fridley, Minnesota, United States

Site Status

Oregon Dermatology and Research Center

Portland, Oregon, United States

Site Status

J&S Studies, Inc

College Station, Texas, United States

Site Status

Suzanne Bruce and Associates, P.A.,The Center for Skin Research

Houston, Texas, United States

Site Status

Virginia Clinical Research, Inc.

Norfolk, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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CP0108A

Identifier Type: -

Identifier Source: org_study_id

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