CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 120 enrolled
Drug / intervention
Metvix® cream +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00469417
NCT00469417Phase 3Completed
CompareCT.gov

A Multicenter, Phase III, Randomised Study of Photodynamic Therapy With Metvix Cream 160 mg/g in Comparison With Cryotherapy in Patients With Primary Superficial Basal Cell Carcinoma

Galderma R&D·interventional·Posted May 4, 2007·Updated Aug 19, 2024

In Brief

A Phase 3 clinical trial evaluating Metvix® cream and Hand held liquid nitrogen spray cryotherapy for Superficial Basal Cell Carcinoma. Completed, enrolled 120 participants across 14 sites in 7 countries.

Detailed Summary

The purpose of this study was to compare the efficacy of Photodynamic Therapy (PDT) methyl aminolevulinate (MAL) cream to cryotherapy, in treatment of participants with primary superficial basal cell carcinoma (BCC). Secondary objectives was to compare cosmetic outcome and tolerability (adverse events) in these participants, 3 months after treatment. In addition the recurrence rates in the two treatment groups will be compared up to five years after treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSuperficial Basal Cell Carcinoma
CountriesAustria, Belgium, Finland, France, Italy, Sweden, United Kingdom
Collaborators--

Timeline

Phase 3CompletedFinished
2000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 4, 2007
Enrollment StartOct 18, 1999
Primary CompletionSep 5, 2001
Study CompletionApr 1, 2005
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 19.2 years ago

Interventions

Metvix® creamdrug

Hand held liquid nitrogen spray cryotherapyprocedure