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

Galderma R&D131 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

131

Conditions

Actinic Keratoses

Interventions

NDL-PDTDRUG

Metvix natural daylight photodynamic therapy

c-PDTDRUG

Metvix conventional photodynamic therapy

placebo c-PDTDRUG

Metvix placebo conventional photodynamic therapy

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Clinical diagnosis of mild (Grade 1) and/or moderate (Grade 2) AKs on the face or the scalp on treated areas * Subject with two symmetrical treated areas half scalps or two half faces excluding ears, chin, bridge of the nose, eyelids and lips inside the vermillion border): no more than a twofold difference in terms of total number of lesions between the two TAs Exclusion Criteria: * Subject with clinical diagnosis of at least one severe (Grade 3) AK on treated areas * Subject with pigmented AK on the treated areas * Immuno-compromised Subject for idiopathic, disease specific or therapeutic reasons * Subject with porphyria,

Locations (18)

Investigative site

Montpellier, France

Investigational site

Nantes, France

Investigational site

Nice, France

Outcomes

Primary Outcomes

Percentage (%) Change From Baseline in Total Lesion Complete Response at Week 12 in Group 1

The lesion complete response rate was defined as the percentage of pre-existing and treated lesions at Baseline that were assessed as clear (complete disappearance of the lesion, visually and by palpation) at Week 12. New lesions or the lesions in non-complete response were not not considered in the lesion response assessment. This outcome measure was analyzed as an intra-individual comparison between Metvix NDL-PDT on one side of the face/scalp and Metvix vehicle cream (placebo) c-PDT on the contralateral side (Group I).

Time frame: Baseline, Week 12

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.