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

Actinic Keratoses Clinical Trial

— COMET2  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01821391
• Other study ID #: RD.03.SPR.29112
• Status: Completed
• Phase: Phase 3
• Start date: July 2013
• Est. completion date: March 2014

Study information

• Verified date: February 2018
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 131
• Est. completion date: March 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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,

Related Conditions & MeSH terms

• Actinic Keratoses
• Keratosis
• Keratosis, Actinic

Intervention

Drug:
• NDL-PDT
Metvix natural daylight photodynamic therapy
• c-PDT
Metvix conventional photodynamic therapy
• placebo c-PDT
Metvix placebo conventional photodynamic therapy

Locations

Country	Name	City	State
France	Investigative site	Montpellier
France	Investigational site	Nantes
France	Investigational site	Nice
France	Investigational site	Paris
France	Investigative site	Rennes
Germany	Investigational site	Aachen
Germany	Investigational site	Berlin
Germany	Investigational site	Muenster
Germany	Investigational site	Recklinghausen
Netherlands	Investigational site	Assen
Netherlands	Investigational site	Maastricht
Netherlands	Investigational site	Nijmegen
Spain	Investigational site	Huesca
Spain	Investigational site	Madrid
Spain	Investigative site	Pamplona
Spain	Investigational site	Valencia
Sweden	Investigational site	Karlskoga
Sweden	Investigational site	Norrköping

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Countries where clinical trial is conducted

France,  Germany,  Netherlands,  Spain,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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