NCT00472043

PDT With Metvix 160 mg/g Cream Versus PDT With Placebo Cream in Participants With Primary Nodular Basal Call Carcinoma

A Multicentre, Phase III, Double Blind Study of Photodynamic Therapy (PDT) With Metvix® 160 mg/g Cream in Comparison to PDT With Placebo Cream in Participants With Primary Nodular Basal Cell Carcinoma

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 66 (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 had 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 levels of photoactive porphyrins 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 participant complete response rates based on histologically verified disappearance of the lesions at 6 months after last treatment cycle. Secondary objectives were 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 participant was randomised to PDT with Metvix® cream or PDT with placebo cream. All eligible Basal cell carcinoma (BCC) lesions within a participant had got the same treatment. All participants got two consecutive treatments one week apart. At the 3-months follow-up visit, lesions with no clinical response or progression had been surgically excised. Lesions with partial response (50% or greater reduction on lesion area) had been re-treated, if they do not show complete response three months later they would have been be surgically excised. Lesions with complete response had been surgically excised 6 months after the first or second PDT cycle. All excised tissue specimens had been histologically examined.

Conditions

• Basal Cell Carcinoma

Interventions

Type	Name	Description
DRUG	PDT with Metvix 160 mg/g cream
DRUG	Placebo

Timeline

• Start date: 2000-10-01
• Primary completion: 2002-09-30
• Completion: 2002-09-30
• First posted: 2007-05-11
• Last updated: 2024-08-06
• Results posted: 2024-08-06

Locations

7 sites across 1 country: Australia