Actinic keratosis of the scalp Traitment

Comparison of Efficacy and Safety of Metvixia® Natural Daylight Photodynamic Therapy Versus Conventional Metvixia® Photodynamic Therapy in patients With grade I and II actinic keratosis of the scalp: a phase III trial - Metvix®, Natural Daylight Photodynamic Therapy, Actinic keratosis

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-003602-32-FR

Enrollment

Registered

2015-06-22

Start date

2014-10-15

Completion date

Unknown

Last updated

2018-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

actinic keratosis MedDRA version: 18.0 Level: PT Classification code 10000614 Term: Actinic keratosis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders

Interventions

Trade Name: Metvixia Pharmaceutical Form: Cream

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: •Clinical diagnosis of at least 10 previously untreated AK lesions of Grade 1 and/or 2 of the scalp (at least 5 KA at each hlf of the scalp) •Males or females above 18 years of age. •Written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 11 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15

Exclusion criteria

Exclusion criteria: - Patients with porphyria. -Known allergy to metvixia® compound or excipients of the cream. -Patients with history of hypersensitivity to nut products -Patients receiving local treatment in the scalp areaea within the last 30 days. -Patients receiving topical treatment,chemotherapy or immunotherapy in scalp area within the last 2 months. -Sclerodermiform / nodular basal cell/intraepithelial carcinoma in the treated area -Pregnant or breast-feeding women

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate clinical efficacy of daylight photodynamic therapy using Metvixia®compared to conventional PDT treatment using Metvixia®;Secondary Objective: 1 To assess the safety of treatment 2 To assess the clinical efficacy at 1 month and 6 months post treatment 3 To assess the appearance of new keratoses 1 month rate, 3 months and 6 months 4 To consider the possible relationship between treatment efficacy at 1 month, 3 months and 6 months depending on the amount of light received;Primary end point(s): Number of disapeared Actinic Keratosis at 3 month;Timepoint(s) of evaluation of this end point: At 3 month	—

Measure

Time frame

Main Objective: To evaluate clinical efficacy of daylight photodynamic therapy using Metvixia®compared to conventional PDT treatment using Metvixia®;Secondary Objective: 1 To assess the safety of treatment 2 To assess the clinical efficacy at 1 month and 6 months post treatment 3 To assess the appearance of new keratoses 1 month rate, 3 months and 6 months 4 To consider the possible relationship between treatment efficacy at 1 month, 3 months and 6 months depending on the amount of light received;Primary end point(s): Number of disapeared Actinic Keratosis at 3 month;Timepoint(s) of evaluation of this end point: At 3 month

—

Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: Day 0, 1 month, 3 month ant 6 month;Secondary end point(s): - To evaluate the safety of treatment (questionnaire and pain assessment) - The disappearance rate at 1 month and 6 months (relative to the layer of the inclusion visit) - The emergence of new keratoses at 1 month and 6 months (new KAappeared) rates. - The relationship between dose of sunlight received, measured by the luxmeter worn by the patient at the time of exposure, and clinical efficacy 1 month, 3 months and 6 months	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: Day 0, 1 month, 3 month ant 6 month;Secondary end point(s): - To evaluate the safety of treatment (questionnaire and pain assessment) - The disappearance rate at 1 month and 6 months (relative to the layer of the inclusion visit) - The emergence of new keratoses at 1 month and 6 months (new KAappeared) rates. - The relationship between dose of sunlight received, measured by the luxmeter worn by the patient at the time of exposure, and clinical efficacy 1 month, 3 months and 6 months

—

Countries

France

Contacts

Public ContactProject manager

CHU de Limoges

abdeslam.bentaleb@chu-limoges.fr05 55 05 86 16

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026