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Phase 3b Study of Metvix NDL-PDT Versus Metvix c-PDT in Subjects With Actinic Keratoses (COMET2)

Primary Purpose

Actinic Keratoses

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

NDL-PDT

c-PDT

placebo c-PDT

About this trial

This is an interventional treatment trial for Actinic Keratoses focused on measuring actinic keratoses, photodynamic therapy, natural daylight

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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,

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

NDL-PDT/c-PDT

NDL-PDT/placebo c-PDT

Arm Description

Metvix natural daylight photodynamic therapy and Metvix conventional photodynamic therapy

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

NCT ID

NCT01821391

First Posted

March 27, 2013

Last Updated

February 16, 2021

Sponsor

Galderma R&D

1. Study Identification

Unique Protocol Identification Number

NCT01821391

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2018

Overall Recruitment Status

Completed

Study Start Date

July 2013 (undefined)

Primary Completion Date

January 2014 (Actual)

Study Completion Date

March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Galderma R&D

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Actinic Keratoses

Keywords

actinic keratoses, photodynamic therapy, natural daylight

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Model Description

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

Masking

Investigator

Allocation

Randomized

Enrollment

131 (Actual)

8. Arms, Groups, and Interventions

Arm Title

NDL-PDT/c-PDT

Arm Type

Experimental

Arm Description

Metvix natural daylight photodynamic therapy and Metvix conventional photodynamic therapy

Arm Title

NDL-PDT/placebo c-PDT

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

NDL-PDT

Other Intervention Name(s)

Metvix NDL-PDT

Intervention Description

Metvix natural daylight photodynamic therapy

Intervention Type

Drug

Intervention Name(s)

c-PDT

Other Intervention Name(s)

Metvix c-PDT

Intervention Description

Metvix conventional photodynamic therapy

Intervention Type

Drug

Intervention Name(s)

placebo c-PDT

Other Intervention Name(s)

Metvix placebo c-PDT

Intervention Description

Metvix placebo conventional photodynamic therapy

Primary Outcome Measure Information:

Title

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

Description

Time Frame

Baseline, Week 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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,

Overall Study Officials: