Metvix PDT Versus Vehicle PDT With Aktilite CL128 Lamp in Patients With Actinic Keratosis on the Face and Scalp

PHASE3CompletedINTERVENTIONAL
Enrollment

131

Participants

Timeline

Start Date

March 13, 2006

Primary Completion Date

January 23, 2007

Study Completion Date

January 23, 2007

Conditions
Actinic Keratosis
Interventions
COMBINATION_PRODUCT

Metvix-PDT

Metvix 160 mg/g Cream was applied for 3 hours with occlusive dressing, and illumination with non-coherent red light using the Aktilite CL128 lamp, with a total light dose 37 Joule/square centimeter (J/cm²). All eligible lesions on the participant were treated twice with an interval of 1 week between treatments.

COMBINATION_PRODUCT

Vehicle-PDT

Vehicle Cream was applied for 3 hours with occlusive dressing, and illumination with non-coherent red light using the Aktilite CL128 lamp, with a total light dose 37 J/cm². All eligible lesions on the participant were treated twice with an interval of 1 week between treatments.

Trial Locations (11)

23538

Klinik für Dermatologie und Venerologie Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Lübeck

40202

Joseph Fowler, Louisville

40223

Hautklinik Heinrich Heine Universität, Düsseldorf

60563

Ashish C. Bhatia, Naperville

60590

Klinikum der Johann Wolfgang Goethe-Universität Frankfurt am Main, Frankfurt

78229

Steven A. Davis, San Antonio

80337

Klinikum der Universität München, Klinikum und Poliklinik für Dermatologie und Allergologie, München

82205

Praxis Dr. Winfried Klövekorn, Gilching

82327

Praxis Dr. Klemm, Tutzing

93053

Klinik und Poliklinik für Dermatologie, Klinikum der Universität Regensburg, Regensburg

97223

Robert T. Matheson, Portland

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Galderma R&D

INDUSTRY