Actinic KeratosesPhase 3COMET2NCT01821391

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

A Phase 3 study testing NDL-PDT and c-PDT in people with Actinic Keratoses, run by Galderma R&D at 18 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Actinic Keratoses
What is being tested?: NDL-PDT and c-PDT
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 131 participants
Where: 18 sitesin 5 countries
Study dates: Jul 2013to Mar 2014
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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,

Trial locations and contacts

18 sites in 5 countries.

Country

City, postcode or hospital

18 sites in 5 countries

France5 sites

Investigative site
Montpellier
Investigational site
Nantes
Investigational site
Nice
Investigational site
Paris
Investigative site
Rennes

Other trials in France

Germany4 sites

Investigational site
Aachen
Investigational site
Berlin
Investigational site
Münster
Investigational site
Recklinghausen

Other trials in Germany

Spain4 sites

Investigational site
Huesca
Investigational site
Madrid
Investigative site
Pamplona
Investigational site
Valencia

Other trials in Spain

Netherlands3 sites

Investigational site
Assen
Investigational site
Maastricht
Investigational site
Nijmegen

Other trials in Netherlands

Sweden2 sites

Investigational site
Karlskoga
Investigational site
Norrköping

Other trials in Sweden

About this study

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

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
Being tested: NDL-PDT, c-PDT, placebo c-PDT
Keywords: actinic keratoses, photodynamic therapy, natural daylight
Medical subject headings: Keratosis, Actinic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NDL-PDTDrug
Also called Metvix NDL-PDT
Metvix natural daylight photodynamic therapy
c-PDTDrug
Also called Metvix c-PDT
Metvix conventional photodynamic therapy
placebo c-PDTDrug
Also called Metvix placebo c-PDT
Metvix placebo conventional photodynamic therapy

Study groups in NCT01821391
Study group	Role	What they receive
NDL-PDT/c-PDT	Experimental	Metvix natural daylight photodynamic therapy and Metvix conventional photodynamic therapy Receives: Drug: NDL-PDT; Drug: c-PDT
NDL-PDT/placebo c-PDT	Experimental	Metvix natural daylight photodynamic therapy and Metvix-placebo conventional photodynamic therapy Receives: Drug: NDL-PDT; Drug: placebo c-PDT

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: Baseline, Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2013Mar 2014

First posted1 Apr 2013 (estimated)
Study startJul 2013
Primary completionJan 2014
Study completionMar 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Actinic KeratosesStudies of the same condition, open and under way.
More trials run by Galderma R&DThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Model description: 2 intra-individual groups: * Metvix NDL-PDT / Metvix c-PDT * Metvix NDL-PDT / Placebo c-PDT
Masking: Single blind
Who is masked: Investigator
Enrolment: 131 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01821391
Sponsor's protocol ID: RD.03.SPR.29112
Acronym: COMET2
Status last verified: Feb 2018
First submitted: 27 Mar 2013
Last updated: 18 Feb 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study of Reformulated Levulan Kerastick Plus PDT for Actinic Keratosis on Upper Extremities
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Study of Reformulated Levulan Kerastick Plus PDT for Actinic Keratosis on Face and Scalp
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A Pilot Clinical Trial Comparing Topical Fluorouracil to Fluorouracil Plus Calcipotriene Field Treatments in Patients With Multiple Actinic Keratoses
Multiple Actinic Keratoses
RecruitingPhase 3
Basal Cell Carcinoma Chemoprevention Trial
Basal Cell Carcinoma
Active, not recruitingPhase 4
Cryotherapy in Combination With Red Light PDT for Actinic Keratosis of Full Face
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All Actinic Keratoses trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01821391
Acronym / sponsor ID: COMET2 / RD.03.SPR.29112
Conditions: Actinic Keratoses
Keywords: actinic keratoses, photodynamic therapy, natural daylight
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 131 participants (actual)
Lead sponsor: Galderma R&DIndustry (pharma, biotech, devices)
Study start: Jul 2013
Primary completion: Jan 2014 (actual)
Study completion: Mar 2014 (actual)
First posted: 1 Apr 2013 (estimated)
Results: Posted 10 Dec 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Single blind (investigator)
Number of arms: 2
Model description: 2 intra-individual groups: * Metvix NDL-PDT / Metvix c-PDT * Metvix NDL-PDT / Placebo c-PDT

Arm	Type	Receives
NDL-PDT/c-PDT	Experimental	Drug: NDL-PDT, Drug: c-PDTMetvix natural daylight photodynamic therapy and Metvix conventional photodynamic therapy
NDL-PDT/placebo c-PDT	Experimental	Drug: NDL-PDT, Drug: placebo c-PDTMetvix natural daylight photodynamic therapy and Metvix-placebo conventional photodynamic therapy

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (4 listed)

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,

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
NDL-PDTAlso: Metvix NDL-PDTMetvix natural daylight photodynamic therapy	Drug	NDL-PDT/c-PDT, NDL-PDT/placebo c-PDT
c-PDTAlso: Metvix c-PDTMetvix conventional photodynamic therapy	Drug	NDL-PDT/c-PDT
placebo c-PDTAlso: Metvix placebo c-PDTMetvix placebo conventional photodynamic therapy	Drug	NDL-PDT/placebo c-PDT

Primary outcome

Percentage (%) Change From Baseline in Total Lesion Complete Response at Week 12 in Group 1
Time frame: Baseline, Week 12
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).

Results and safety

Results posted to the registry on 10 Dec 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group 1	108	107
Group 2	23	23

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

Time frame: Baseline, Week 12. Mean (Standard Deviation). Unit: percentage change from baseline

Measure	Group I: Metvix NDL-PDT n = 108	Group I: Metvix c-PDT n = 108
Value	68.4 (27.7)	71.5 (27.6)

Group I: Metvix NDL-PDT vs Group I: Metvix c-PDT: p =0.2665, Paired Student's t test

Population analysed: Intent-to-treat (ITT) population included entire population enrolled and randomized. ITT analysis imputed missing data using a worst case approach and considered the lesions with missed lesion response assessment as not responded (ITT/Worst-case) lesions.

Adverse events

Time frame: 3 months. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
NDL-PDT	0 of 131 (0%)	65 of 131 (49.6%)	0 of 131
c-PDT	0 of 108 (0%)	66 of 108 (61.1%)	0 of 108
Placebo c-PDT	0 of 23 (0%)	7 of 23 (30.4%)	0 of 23
Unspecific Treated Side	6 of 131 (4.6%)	3 of 131 (2.3%)	1 of 131

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Actinic Keratoses

RecruitingPhase 3
Study of Reformulated Levulan Kerastick Plus PDT for Actinic Keratosis on Upper Extremities
Actinic Keratosis
RecruitingPhase 3
Study of Reformulated Levulan Kerastick Plus PDT for Actinic Keratosis on Face and Scalp
Actinic Keratosis
Active, not recruitingPhase 3
A Pilot Clinical Trial Comparing Topical Fluorouracil to Fluorouracil Plus Calcipotriene Field Treatments in Patients With Multiple Actinic Keratoses
Multiple Actinic Keratoses
RecruitingPhase 3
Basal Cell Carcinoma Chemoprevention Trial
Basal Cell Carcinoma
Active, not recruitingPhase 4
Cryotherapy in Combination With Red Light PDT for Actinic Keratosis of Full Face
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Nicole Basset Seguin, PhD, MD principal investigator

Hopital Saint Louis France

Bibiana Perez Garcia, MD principal investigator

Hospital Ramón y Cajal Spain

Rianne Gerritsen, PhD, MD principal investigator

Radboud University, Nijmegen Medical Center The Netherlands

18 sites in 5 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing NDL-PDT and c-PDT in people with Actinic Keratoses, run by Galderma R&D at 18 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in France, Germany, Spain, Netherlands, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage (%) Change From Baseline in Total Lesion Complete Response at Week 12 in Group 1 (time frame: Baseline, Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01821391.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2021.