NCT02373371

Brief 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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Mar 2015

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 16, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 27, 2015

Completed
26 days until next milestone

Study Start

First participant enrolled

March 25, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 22, 2016

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
10 months until next milestone

Results Posted

Study results publicly available

April 8, 2019

Completed
Last Updated

July 29, 2025

Status Verified

August 1, 2018

Enrollment Period

1.7 years

First QC Date

February 16, 2015

Results QC Date

January 9, 2019

Last Update Submit

July 13, 2025

Conditions

Actinic Keratoses

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline and Week 12

Secondary Outcomes (3)

  • Pain Assesment

    at inclusion (after treatment)

  • Lesions Disappearance Rate at 1 Months From Baseline.

    0(baseline),1 month

  • Lesions Disappearance Rate at 6 Months From Baseline.

    0(baseline), 6 month

Study Arms (2)

Daylight

EXPERIMENTAL

Metvix® (160mg/g) and Photodynamic Therapy Daylight One session at baseline

Drug: Metvix®Procedure: Photodynamic Therapy Daylight

Conventional treatment

ACTIVE COMPARATOR

Metvix® (160mg/g) and Photodynamic Therapy Blue light One session at baseline

Drug: Metvix®Procedure: Photodynamic Therapy Blue light

Interventions

Metvix®DRUG
Conventional treatmentDaylight
Photodynamic Therapy Blue lightPROCEDURE

Photodynamic therapy (PDT) is a medical treatment that utilizes a photosensitizing molecule (Metvix) and a blue light source to activate the applied drug

Conventional treatment
Photodynamic Therapy DaylightPROCEDURE

Photodynamic therapy (PDT) is a medical treatment that utilizes a photosensitizing molecule (Metvix) and a the day light to activate the applied drug

Daylight

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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);

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Limoges University Hospital

Limoges, 87042, France

Location

Related Publications (1)

  • 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.

    PMID: 31955461RESULT

MeSH Terms

Conditions

Keratosis, Actinic

Interventions

methyl 5-aminolevulinatePhotochemotherapy

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsKeratosisSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeuticsDrug TherapyPhototherapy

Results Point of Contact

Title
Project Manager
Organization
CHU de Limoges
abdeslam.bentaleb@chu-limoges.fr
0555058616

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2015

First Posted

February 27, 2015

Study Start

March 25, 2015

Primary Completion

November 22, 2016

Study Completion

June 1, 2018

Last Updated

July 29, 2025

Results First Posted

April 8, 2019

Record last verified: 2018-08

Locations

FR(1)