NCT00472108

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: Galderma R&D · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

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 received two consecutive treatments one week apart. At the 3-months follow-up visit, lesions with no clinical response or progression were surgically excised. Lesions with partial response 50 percent (%) or greater reduction on lesion area) were re-treated; if they do not show complete response three months later, they were surgically excised. Lesions with complete response were surgically excised 6 months after the first or second PDT cycle. All excised tissue specimens were histologically examined.

Conditions

• Basal Cell Carcinoma

Interventions

Type	Name	Description
RADIATION	Photodynamic Therapy (PDT)
DRUG	Metvix cream
DRUG	Placebo Cream

Timeline

• Start date: 2000-12-01
• Primary completion: 2002-04-01
• Completion: 2002-04-01
• First posted: 2007-05-11
• Last updated: 2024-08-05
• Results posted: 2024-08-05

Locations

9 sites across 1 country: United States