Photodynamic Therapy (PDT) With Metvix Cream 160 mg/g Versus PDT With Placebo Cream in Participants With Primary Nodular Basal Cell Carcinoma

Completed · Phase 3 · Has a placebo group

Conditions studied: Basal Cell Carcinoma

In brief

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 normal cells. The photosensitiser generated reactive oxygen species upon illumination. For skin diseases, there had been an increasing interest in using precursors of the endogenous photosensitiser protoporphyrin IX (PpIX). The most commonly used precursors have been 5-aminolevulinic acid (ALA) and its derivatives. The present test drug, Metvix, contained the methyl ester of ALA, which penetrated the lesions well and shows high lesion selectivity. In vitro studies of animal and human tissues had shown significant intracellular formation of photoactive porphyrins after addition of Metvix. The increased photoactive porphyrins levels induced cytotoxic effects in tumour cells after photoactivation. The primary objective was to compare PDT with Metvix cream to PDT with placebo cream in terms of participants complete response rates based on histologically verified disappearance of the lesions at 6 months after last treatment cycle. Secondary objectives was to compare the two treatments in terms of histological and clinical mean participant response weighted by the number of lesions within a participant, lesion response rates across participants, clinical complete participant response, cosmetic outcome and adverse events.

Key facts

Study ID

NCT00472108

Run by

Galderma R&D

People needed

65

Starts

2000-12-01

Expected to finish

2002-04-01

Last updated by the study team

2024-08-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 Exclusion Criteria:
• A nodular BCC lesion in periorbital area, ears and nasolabial fold.
• A nodular BCC lesion with the longest diameter less than 6 millimeter (mm) or larger than 15 mm in face/scalp, larger than 20 mm on extremities and neck and larger than 30 mm on truncus.
• Pigmented nodular BCC lesion(s)
• Morpheaform nodular BCC lesion(s).
• Infiltrating nodular BCC lesion(s).
• Prior treatment of the BCC lesion(s).

Where it is running

• Clinical Research Specialists Inc — Santa Monica, California, United States
• Department of Dermatology, University of Minnesota Hospital and Clinic — Minneapolis, Minnesota, United States
• Department of Dermatology, Mayo Medical School, Mayo Clinic — Rochester, Minnesota, United States
• Academic Dermatology Associates — Albuquerque, New Mexico, United States
• Department of Dermatology, Roswell Park Cancer Institue — Buffalo, New York, United States
• Northwest Cutaneous Research Specialists — Portland, Oregon, United States
• DermResearch, Inc. — Austin, Texas, United States
• Texas Dermatology Research Institute — Dallas, Texas, United States
• Virginia Clinical Research, Inc. — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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