Status:
COMPLETED
Photodynamic Therapy (PDT) With Metvix Cream 160 mg/g Versus PDT With Placebo Cream in Participants With Primary Nodular Basal Cell Carcinoma
Lead Sponsor:
Galderma R&D
Conditions:
Basal Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Photodynamic therapy (PDT) was the selective destruction of abnormal cells through light activation of a photosensitiser in the presence of oxygen. These cells accumulated more photosensitiser than no...
Detailed Description
A participants were randomised to PDT with Metvix cream or PDT with placebo cream. All eligible basal cell carcinoma (BCC) lesions within a participant received same treatment. All participants receiv...
Eligibility Criteria
Inclusion
- A participant with primary, nodular BCC lesion(s) suitable for entry is defined as a participant with
- Clinically diagnosed primary nodular BCC lesion(s).
- Histologically confirmed diagnosis of BCC.
- BCC lesions suitable for simple excision surgery.
- Males or females above 18 years of age.
- Written informed consent.
Exclusion
- A participant that is ineligible for inclusion is a participant fulfilling any of the following criteria:
- Participants with porphyria.
- Participants with Gorlin's syndrome.
- Participants with Xeroderma pigmentosum.
- Participants concurrently receiving immunosuppressive medication.
- Participants with a history of arsenic exposure.
- Participants with BCC arising in a previous radiated area.
- Known allergy to Metvix, a similar PDT compound or excipients of the cream.
- Participation in other clinical studies either concurrently or within the last 30 days.
- Pregnant or breast-feeding: All women of child-bearing potential must use adequate contraception (e.g. barrier methods, oral contraceptives or intrauterine device) during the treatment period and one month thereafter. In addition, they must have a negative pregnancy test prior to treatment..
- Conditions associated with a risk of poor protocol compliance.
- Lesion
Key Trial Info
Start Date :
December 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2002
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT00472108
Start Date
December 1 2000
End Date
April 1 2002
Last Update
August 5 2024
Active Locations (9)
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1
Clinical Research Specialists Inc
Santa Monica, California, United States, 90404-2115
2
Department of Dermatology, University of Minnesota Hospital and Clinic
Minneapolis, Minnesota, United States, 55455
3
Department of Dermatology, Mayo Medical School, Mayo Clinic
Rochester, Minnesota, United States, 55905
4
Academic Dermatology Associates
Albuquerque, New Mexico, United States, 87106