Twelve Month Follow-Up of CP0108

Dusa Pharmaceuticals

Status: Completed

Conditions: Actinic Keratosis

Treatments: Drug: Topical Solution Vehicle; Drug: Aminolevulinic Acid (ALA); Device: BLU-U Blue Light Photodynamic Therapy Illuminator

Study type: Observational

Funder types: Industry

Identifiers

NCT02209012

CP0108A

Details and patient eligibility

About

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.

Enrollment: 206 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

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

Trial design

206 participants in 2 patient groups

ALA

Description:

Subjects who received ALA in CP0108

Treatment:

Drug: Aminolevulinic Acid (ALA)

Device: BLU-U Blue Light Photodynamic Therapy Illuminator

Vehicle

Description:

Subjects who received Vehicle in CP0108

Treatment:

Device: BLU-U Blue Light Photodynamic Therapy Illuminator

Drug: Topical Solution Vehicle