CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 100 enrolled
Drug / intervention
Metvix and natural daylight PDT +1 moredrug
Likely dose
Metvix and natural daylight PDT 160mgfrom 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/NCT01475071
NCT01475071Phase 3Completed

Intra-individual Comparison of Efficacy and Safety of Metvix® Natural Daylight Photodynamic Therapy Versus Conventional Metvix® Photodynamic Therapy in Subject With Mild Actinic Keratoses.

Galderma R&D·interventional·Posted Nov 21, 2011·Updated Feb 18, 2021

In Brief

A Phase 3 clinical trial evaluating Metvix and natural daylight PDT and Metvix and conventional PDT for Actinic Keratoses. Completed, enrolled 100 participants across 6 sites.

Detailed Summary

The main objective of this study is to compare efficacy and safety of Metvix® natural daylight photodynamic therapy with those of Metvix® conventional photodynamic therapy with Aktilite™ lamp in subjects with mild actinic keratoses (intra-individual comparison).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedNov 21, 2011
Enrollment StartMar 1, 2012
Primary CompletionNov 1, 2012
Study CompletionMar 1, 2013
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 14.6 years ago

Interventions

Metvix and natural daylight PDTdrug

Methyl aminolevulinate, cream 160mg/g.One session at baseline and a second session administration at week 12 for lesions showing non-complete response and new lesions on target area.

Metvix and conventional PDTdrug

Methyl aminolevulinate, cream, 160mg/g. One session at baseline and a second session administration at week 12 for lesions showing non-complete response and new lesions on target area.