Actinic KeratosesPhase 3NCT02373371

Actinic Keratoses Treatment With Metvix® in Combination With Light

A Phase 3 study testing Metvix®, Photodynamic Therapy Blue light and Photodynamic Therapy Daylight in people with Actinic Keratoses, run by University Hospital, Limoges at 1 site in France.

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

The main objective of this study is to compare efficacy and safety of Metvix® natural daylight photodynamic therapy with those of Metvix® conventional photodynamic therapy in subjects with mild actinic keratoses (intra-individual comparison) 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?: Metvix®, Photodynamic Therapy Blue light and Photodynamic Therapy Daylight
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 26 participants
Where: 1 siteFrance
Study dates: 25 Mar 2015to 1 Jun 2018
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

Male or female above 18 years;
Subject with clinical diagnosis of mild Actinic Keratosis (AK) on the face or the scalp with or without clinical diagnosis of moderate AK on the target areas (TAs);

Who cannot join

Subject with clinical diagnosis of at least one severe AK on TAs
Subject with clinical diagnosis of other skin disease (including non-melanoma skin cancer) on the TAs;
Subject with pigmented AK on the TAs

Trial locations and contacts

1 site in 1 country.

France1 site

Limoges University Hospital
Limoges, 87042

Other trials in France

About this study

Official title: Efficacy and Safety of Metvix® Natural Daylight Photodynamic Therapy Versus Conventional Metvix® Photodynamic Therapy in Subject With Mild Actinic Keratoses

Conditions: Actinic Keratoses
Being tested: Metvix®, Photodynamic Therapy Blue light, Photodynamic Therapy 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.

Metvix®Drug
Photodynamic Therapy Blue lightProcedure or surgery
Photodynamic therapy (PDT) is a medical treatment that utilizes a photosensitizing molecule (Metvix) and a blue light source to activate the applied drug
Photodynamic Therapy DaylightProcedure or surgery
Photodynamic therapy (PDT) is a medical treatment that utilizes a photosensitizing molecule (Metvix) and a the day light to activate the applied drug

Study groups in NCT02373371
Study group	Role	What they receive
Daylight	Experimental	Metvix® (160mg/g) and Photodynamic Therapy Daylight One session at baseline Receives: Drug: Metvix®; Procedure: Photodynamic Therapy Daylight
Conventional treatment	Active comparator	Metvix® (160mg/g) and Photodynamic Therapy Blue light One session at baseline Receives: Drug: Metvix®; Procedure: Photodynamic Therapy Blue light

What is being measured

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

Mean Change From Baseline in Total Number of Treated Mild Lesions Per Side at Week 12
The number of lesions is assessed at baseline (before treatment) and 12 weeks later.
The difference in lesions is recorded for each patient. The mean of disappeared lesions are then calculated for all patients.
Measured: Baseline and Week 12

Secondary outcomes (3)

Pain Assesment
Pain assesment with a VAS Pain scale
Visual analog scale [VAS] is a continuous scale comprised of a horizontal scale of 10 cm length . The scale is anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 10).
Measured: at inclusion (after treatment)
Lesions Disappearance Rate at 1 Months From Baseline.
The number of lesions is assessed at baseline (before treatment) and 1 month later.
The difference in lesions is recorded for each patient. The rate is the quotient: " difference in lesions between baseline and at 1 month "/nubmer of lesions at baseline
Measured: 0(baseline),1 month
Lesions Disappearance Rate at 6 Months From Baseline.
The number of lesions is assessed at baseline (before treatment) and 6 month later.
The difference in lesions is recorded for each patient. The rate is the quotient: " difference in lesions between baseline and at 6 month "/nubmer of lesions at baseline
Measured: 0(baseline), 6 month

Timeline

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

25 Mar 20151 Jun 2018

First posted27 Feb 2015 (estimated)
Study start25 Mar 2015
Primary completion22 Nov 2016
Study completion1 Jun 2018

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Actinic KeratosesStudies of the same condition, open and under way.
More trials run by University Hospital, LimogesThe 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
Masking: None (open label)
Enrolment: 26 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02373371
Sponsor's protocol ID: I14034
Status last verified: Aug 2018
First submitted: 16 Feb 2015
Last updated: 29 Jul 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Assikar S, Labrunie A, Kerob D, Couraud A, Bedane C. Daylight photodynamic therapy with methyl aminolevulinate cream is as effective as conventional photodynamic therapy with blue light in the treatment of actinic keratosis: a controlled randomized intra-individual study. J Eur Acad Dermatol Venereol. 2020 Aug;34(8):1730-1735. doi: 10.1111/jdv.16208. Epub 2020 Feb 21.
PubMed 31955461

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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All Actinic Keratoses trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Safety of Metvix® Natural Daylight Photodynamic Therapy Versus Conventional Metvix® Photodynamic Therapy in Subject With Mild Actinic Keratoses
ClinicalTrials.gov ID: NCT02373371
Acronym / sponsor ID: I14034
Conditions: Actinic Keratoses
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 26 participants (actual)
Lead sponsor: University Hospital, LimogesUniversity, hospital or other
Collaborators: Galderma R&D
Study start: 25 Mar 2015 (actual)
Primary completion: 22 Nov 2016 (actual)
Study completion: 1 Jun 2018 (actual)
First posted: 27 Feb 2015 (estimated)
Results: Posted 8 Apr 2019

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Daylight	Experimental	Drug: Metvix®, Procedure: Photodynamic Therapy DaylightMetvix® (160mg/g) and Photodynamic Therapy Daylight One session at baseline
Conventional treatment	Active comparator	Drug: Metvix®, Procedure: Photodynamic Therapy Blue lightMetvix® (160mg/g) and Photodynamic Therapy Blue light One session at baseline

Who may qualify

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

Key inclusion criteria (2 listed)

Male or female above 18 years;
Subject with clinical diagnosis of mild Actinic Keratosis (AK) on the face or the scalp with or without clinical diagnosis of moderate AK on the target areas (TAs);

Key exclusion criteria (3 listed)

Subject with clinical diagnosis of at least one severe AK on TAs
Subject with clinical diagnosis of other skin disease (including non-melanoma skin cancer) on the TAs;
Subject with pigmented AK on the TAs

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
Metvix®	Drug	Conventional treatment, Daylight
Photodynamic Therapy Blue lightPhotodynamic therapy (PDT) is a medical treatment that utilizes a photosensitizing molecule (Metvix) and a blue light source to activate the applied drug	Procedure or surgery	Conventional treatment
Photodynamic Therapy DaylightPhotodynamic therapy (PDT) is a medical treatment that utilizes a photosensitizing molecule (Metvix) and a the day light to activate the applied drug	Procedure or surgery	Daylight

Primary outcome

Mean Change From Baseline in Total Number of Treated Mild Lesions Per Side at Week 12
Time frame: Baseline and Week 12
The number of lesions is assessed at baseline (before treatment) and 12 weeks later. The difference in lesions is recorded for each patient. The mean of disappeared lesions are then calculated for all patients.

3 secondary outcomes

Pain Assesment
Time frame: at inclusion (after treatment)
Lesions Disappearance Rate at 1 Months From Baseline.
Time frame: 0(baseline),1 month
Lesions Disappearance Rate at 6 Months From Baseline.
Time frame: 0(baseline), 6 month

Results and safety

Results posted to the registry on 8 Apr 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Daylight	13	13
Conventional Treatment	13	13

Primary outcome: Mean Change From Baseline in Total Number of Treated Mild Lesions Per Side at Week 12

Time frame: Baseline and Week 12. Mean (Standard Deviation). Unit: number of lesions

Measure	Daylight n = 13	Conventional Treatment n = 13
Value	19.6 (6.0)	20.0 (6.9)

Daylight vs Conventional Treatment: p = 0.8460, Wilcoxon (Mann-Whitney)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: which adverse event data were collected over 6 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Daylight	1 of 13 (7.7%)	0 of 13 (0%)	0 of 13
Conventional Treatment	1 of 13 (7.7%)	0 of 13 (0%)	0 of 13

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 31955461Assikar S, Labrunie A, Kerob D, Couraud A, Bedane C. Daylight photodynamic therapy with methyl aminolevulinate cream is as effective as conventional photodynamic therapy with blue light in the treatment of actinic keratosis: a controlled randomized intra-individual study. J Eur Acad Dermatol Venereol. 2020 Aug;34(8):1730-1735. doi: 10.1111/jdv.16208. Epub 2020 Feb 21.

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
Actinic Keratoses

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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Metvix®, Photodynamic Therapy Blue light and Photodynamic Therapy Daylight in people with Actinic Keratoses, run by University Hospital, Limoges at 1 site in France.

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 3 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 29 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. 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 8 Apr 2019). 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?

Mean Change From Baseline in Total Number of Treated Mild Lesions Per Side at Week 12 (time frame: Baseline and 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 NCT02373371, which also lists 1 linked publication.

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 29 Jul 2025.