Clinical trial NCT01821391: Phase 3b Study of Metvix NDL-PDT Versus Metvix c-PDT in Subjects With Actinic Keratoses
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Actinic Keratoses
Keywords: actinic keratoses
photodynamic therapy
natural daylight
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2013-04-01
Enrollment: 131
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: 2 intra-individual groups:

* Metvix NDL-PDT / Metvix c-PDT
* Metvix NDL-PDT / Placebo c-PDT
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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,

Primary outcomes:
measure: Percentage (%) Change From Baseline in Total Lesion Complete Response at Week 12 in Group 1
timeFrame: Baseline, Week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Investigative site
city: Nantes
country: France
facility: Investigational site
city: Nice
country: France
facility: Investigational site
city: Paris
country: France
facility: Investigational site
city: Rennes
country: France
facility: Investigative site
city: Aachen
country: Germany
facility: Investigational site
city: Berlin
country: Germany
facility: Investigational site
city: Muenster
country: Germany
facility: Investigational site
city: Recklinghausen
country: Germany
facility: Investigational site
city: Assen
country: Netherlands
facility: Investigational site
city: Maastricht
country: Netherlands
facility: Investigational site
city: Nijmegen
country: Netherlands
facility: Investigational site
city: Huesca
country: Spain
facility: Investigational site
city: Madrid
country: Spain
facility: Investigational site
city: Pamplona
country: Spain
facility: Investigative site
city: Valencia
country: Spain
facility: Investigational site
city: Karlskoga
country: Sweden
facility: Investigational site
city: Norrköping
country: Sweden
facility: Investigational site
Study officials:
affiliation: Hopital Saint Louis France
name: Nicole Basset Seguin, PhD, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Ramón y Cajal Spain
name: Bibiana Perez Garcia, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Radboud University, Nijmegen Medical Center The Netherlands
name: Rianne Gerritsen, PhD, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Klinik fur Dermatologie und Allergologie Germany
name: Rolf-Markus Sziemies, PhD, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hudmottagningen Sweden
name: Ingrid Synnerstad, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References: