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

NCT01821391 | Completed Phase 3 Results

• 1 other identifier: RD.03.SPR.29112
• Study Type: interventional
• Target: 131
• Locations: 5 countries
• Sites: 18

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.

Conditions

Actinic Keratoses

Keywords

actinic keratoses; photodynamic therapy; natural daylight

Outcome Measures

Primary Outcomes (1)

• 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).

  Baseline, Week 12

Study Arms (2)

NDL-PDT/c-PDT

EXPERIMENTAL

Metvix natural daylight photodynamic therapy and Metvix conventional photodynamic therapy

Drug: NDL-PDT; Drug: c-PDT

NDL-PDT/placebo c-PDT

EXPERIMENTAL

Metvix natural daylight photodynamic therapy and Metvix-placebo conventional photodynamic therapy

Drug: NDL-PDT; Drug: placebo c-PDT

Interventions

NDL-PDT DRUG

Metvix natural daylight photodynamic therapy

Also known as: Metvix NDL-PDT

NDL-PDT/c-PDT; NDL-PDT/placebo c-PDT

c-PDT DRUG

Metvix conventional photodynamic therapy

Also known as: Metvix c-PDT

NDL-PDT/c-PDT

placebo c-PDT DRUG

Metvix placebo conventional photodynamic therapy

Also known as: Metvix placebo c-PDT

NDL-PDT/placebo c-PDT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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,

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (18)

Investigative site

Montpellier, France

Location

Investigational site

Nantes, France

Location

Investigational site

Nice, France

Location

Investigational site

Paris, France

Location

Investigative site

Rennes, France

Location

Investigational site

Aachen, Germany

Location

Investigational site

Berlin, Germany

Location

Investigational site

Münster, Germany

Location

Investigational site

Recklinghausen, Germany

Location

Investigational site

Assen, Netherlands

Location

Investigational site

Maastricht, Netherlands

Location

Investigational site

Nijmegen, Netherlands

Location

Investigational site

Huesca, Spain

Location

Investigational site

Madrid, Spain

Location

Investigative site

Pamplona, Spain

Location

Investigational site

Valencia, Spain

Location

Investigational site

Karlskoga, Sweden

Location

Investigational site

Norrköping, Sweden

Location

MeSH Terms

Conditions

Keratosis, Actinic

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: CTA Coordinator
• Organization: Galderma R&D SNC

cta.coordinator@galderma.com

+33 493 95 70 85

Study Officials

• Nicole Basset Seguin, PhD, MD

  Hopital Saint Louis France

  PRINCIPAL INVESTIGATOR

• Bibiana Perez Garcia, MD

  Hospital Ramón y Cajal Spain

  PRINCIPAL INVESTIGATOR

• Rianne Gerritsen, PhD, MD

  Radboud University, Nijmegen Medical Center The Netherlands

  PRINCIPAL INVESTIGATOR

• Rolf-Markus Sziemies, PhD, MD

  Klinik fur Dermatologie und Allergologie Germany

  PRINCIPAL INVESTIGATOR

• Ingrid Synnerstad, PhD, MD

  Hudmottagningen Sweden

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 2 intra-individual groups: * Metvix NDL-PDT / Metvix c-PDT * Metvix NDL-PDT / Placebo c-PDT

Study Record Dates

• First Submitted: March 27, 2013
• First Posted: April 1, 2013
• Study Start: July 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: March 1, 2014
• Last Updated: February 18, 2021
• Results First Posted: December 10, 2020

Record last verified: 2018-02

Locations

FR (5); DE (4); NL (3); ES (4); SE (2)