A Multicenter, Phase III, Double Blind Study of Photodynamic Therapy (PDT) With Metvix 160 mg/g Cream in Comparison to PDT With Placebo Cream in Patients With Primary Nodular Basal Cell Carcinoma
A patient will be randomised to PDT with Metvix cream or PDT with placebo cream. All
eligible BCC lesions within a patient will get the same treatment. All patients will get two
consecutive treatments one week apart. At the 3-months follow-up visit, lesions with no
clinical response or progression will be surgically excised. Lesions with partial response
(50% or greater reduction on lesion area) will be re-treated; if they do not show complete
response three months later, they will be surgically excised. Lesions with complete response
will be surgically excised 6 months after the first or second PDT cycle. All excised tissue
specimens will be histologically examined.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
The primary end-point will be the histologically confirmed complete response rate within a patient (100% of the basal cell carcinoma [BCC] lesions must disappear completely).
6 months after last treatment
Whitney Tope, MPhil, MD
Principal Investigator
University of Minnesota Hospital and Clinic
United States: Food and Drug Administration
PC T307/00
NCT00472108
December 2000
April 2002
Name | Location |
---|---|
Academic Dermatology Associates | Albuquerque, New Mexico 87106 |
Texas Dermatology Research Institute | Dallas, Texas 75230 |
Northwest Cutaneous Research Specialists | Portland, Oregon 97210 |
DermResearch, Inc. | Austin, Texas 78759 |
Virginia Clinical Research, Inc. | Norfolk, Virginia 23507 |
Clinical Research Specialists Inc | Santa Monica, California 90404-2115 |
Department of Dermatology, University of Minnesota Hospital and Clinic | Minneapolis, Minnesota 55455 |
Department of Dermatology, Mayo Medical School, Mayo Clinic | Rochester, Minnesota 55905 |
Department of Dermatology, Roswell Park Cancer Institue | Buffalo, New York 14263 |