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Phase 3b Study of Metvix NDL-PDT Versus Metvix c-PDT in Subjects With Actinic Keratoses

NCT01821391 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 131

Last updated 2021-02-18

Study results available
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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.

Conditions

  • Actinic Keratoses

Interventions

DRUG

NDL-PDT

Metvix natural daylight photodynamic therapy

DRUG

c-PDT

Metvix conventional photodynamic therapy

DRUG

placebo c-PDT

Metvix placebo conventional photodynamic therapy

Sponsors & Collaborators

  • Galderma R&D

    lead INDUSTRY

Principal Investigators

  • Nicole Basset Seguin, PhD, MD · Hopital Saint Louis France

  • Bibiana Perez Garcia, MD · Hospital Ramón y Cajal Spain

  • Rianne Gerritsen, PhD, MD · Radboud University, Nijmegen Medical Center The Netherlands

  • Rolf-Markus Sziemies, PhD, MD · Klinik fur Dermatologie und Allergologie Germany

  • Ingrid Synnerstad, PhD, MD · Hudmottagningen Sweden

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2014-01-31
Completion
2014-03-31

Countries

  • France
  • Germany
  • Netherlands
  • Spain
  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01821391 on ClinicalTrials.gov