CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 131 enrolled
Drug / intervention
NDL-PDT +2 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/NCT01821391
NCT01821391Phase 3Completed
CompareCT.gov

Multi-centre, Randomized, Investigator-blind, Intra-individual Active and Vehicle-controlled Study, Comparing Metvix Natural Daylight Photodynamic Therapy Versus Metvix Conventional Photodynamic Therapy in Subjects With Actinic Keratosis

Galderma R&D·interventional·Posted Apr 1, 2013·Updated Feb 18, 2021

In Brief

A Phase 3 clinical trial evaluating NDL-PDT, c-PDT, and 1 other intervention for Actinic Keratoses. Completed, enrolled 131 participants across 18 sites in 5 countries.

Detailed Summary

This study was to be conducted as a multi-centre, randomized, investigator-blinded, active and vehicle-controlled, intra-individual (split-face/scalp) non-inferiority (regarding efficacy) and superiority (regarding pain) study. The primary purpose of this study is to demonstrate the non-inferiority of NDL-PDT compared to c-PDT in terms of lesion complete response rate.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsActinic Keratoses
CountriesFrance, Germany, Netherlands, Spain, Sweden
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedApr 1, 2013
Enrollment StartJul 1, 2013
Primary CompletionJan 1, 2014
Study CompletionMar 1, 2014
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 13.3 years ago

Interventions

NDL-PDTdrug

Metvix natural daylight photodynamic therapy

c-PDTdrug

Metvix conventional photodynamic therapy

placebo c-PDTdrug

Metvix placebo conventional photodynamic therapy