Trial Outcomes & Findings for Actinic Keratoses Treatment With Metvix® in Combination With Light (NCT NCT02373371)

NCT ID: NCT02373371

Last Updated: 2025-07-29

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 26 participants
• Primary outcome timeframe: Baseline and Week 12
• Results posted on: 2025-07-29

Participant Flow

Participant milestones

Measure	Daylight Metvix® (160mg/g) and Photodynamic Therapy Daylight One session at baseline Metvix® Photodynamic Therapy Daylight: Photodynamic therapy (PDT) is a medical treatment that utilizes a photosensitizing molecule (Metvix) and a the day light to activate the applied drug	Conventional Treatment Metvix® (160mg/g) and Photodynamic Therapy Blue light One session at baseline Metvix® Photodynamic Therapy Blue light: Photodynamic therapy (PDT) is a medical treatment that utilizes a photosensitizing molecule (Metvix) and a blue light source to activate the applied drug
Overall Study STARTED	13	13
Overall Study COMPLETED	13	13
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Actinic Keratoses Treatment With Metvix® in Combination With Light

Baseline characteristics by cohort

Measure	Daylight n=13 Participants Metvix® (160mg/g) and Photodynamic Therapy Daylight One session at baseline Metvix® Photodynamic Therapy Daylight: Photodynamic therapy (PDT) is a medical treatment that utilizes a photosensitizing molecule (Metvix) and a the day light to activate the applied drug	Conventional Treatment n=13 Participants Metvix® (160mg/g) and Photodynamic Therapy Blue light One session at baseline Metvix® Photodynamic Therapy Blue light: Photodynamic therapy (PDT) is a medical treatment that utilizes a photosensitizing molecule (Metvix) and a blue light source to activate the applied drug	Total n=26 Participants Total of all reporting groups
Age, Continuous	75.0 year n=5 Participants	75.0 year n=7 Participants	75.0 year n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	13 Participants n=7 Participants	25 Participants n=5 Participants
Region of Enrollment France	13 participants n=5 Participants	13 participants n=7 Participants	26 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Daylight n=13 Participants Metvix® (160mg/g) and Photodynamic Therapy Daylight One session at baseline Metvix® Photodynamic Therapy Daylight: Photodynamic therapy (PDT) is a medical treatment that utilizes a photosensitizing molecule (Metvix) and a the day light to activate the applied drug	Conventional Treatment n=13 Participants Metvix® (160mg/g) and Photodynamic Therapy Blue light One session at baseline Metvix® Photodynamic Therapy Blue light: Photodynamic therapy (PDT) is a medical treatment that utilizes a photosensitizing molecule (Metvix) and a blue light source to activate the applied drug
Mean Change From Baseline in Total Number of Treated Mild Lesions Per Side at Week 12	19.6 number of lesions Standard Deviation 6.0	20.0 number of lesions Standard Deviation 6.9

SECONDARY outcome

Timeframe: at inclusion (after treatment)

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).

Outcome measures

Measure	Daylight n=13 Participants Metvix® (160mg/g) and Photodynamic Therapy Daylight One session at baseline Metvix® Photodynamic Therapy Daylight: Photodynamic therapy (PDT) is a medical treatment that utilizes a photosensitizing molecule (Metvix) and a the day light to activate the applied drug	Conventional Treatment n=13 Participants Metvix® (160mg/g) and Photodynamic Therapy Blue light One session at baseline Metvix® Photodynamic Therapy Blue light: Photodynamic therapy (PDT) is a medical treatment that utilizes a photosensitizing molecule (Metvix) and a blue light source to activate the applied drug
Pain Assesment	1.2 units on a scale Standard Deviation 1.9	5.1 units on a scale Standard Deviation 2.1

SECONDARY outcome

Timeframe: 0(baseline),1 month

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

Outcome measures

Measure	Daylight n=13 Participants Metvix® (160mg/g) and Photodynamic Therapy Daylight One session at baseline Metvix® Photodynamic Therapy Daylight: Photodynamic therapy (PDT) is a medical treatment that utilizes a photosensitizing molecule (Metvix) and a the day light to activate the applied drug	Conventional Treatment n=13 Participants Metvix® (160mg/g) and Photodynamic Therapy Blue light One session at baseline Metvix® Photodynamic Therapy Blue light: Photodynamic therapy (PDT) is a medical treatment that utilizes a photosensitizing molecule (Metvix) and a blue light source to activate the applied drug
Lesions Disappearance Rate at 1 Months From Baseline.	89.6 percentage of disappeared lesions Standard Deviation 7.2	94.6 percentage of disappeared lesions Standard Deviation 4.8

SECONDARY outcome

Timeframe: 0(baseline), 6 month

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

Outcome measures

Measure	Daylight n=13 Participants Metvix® (160mg/g) and Photodynamic Therapy Daylight One session at baseline Metvix® Photodynamic Therapy Daylight: Photodynamic therapy (PDT) is a medical treatment that utilizes a photosensitizing molecule (Metvix) and a the day light to activate the applied drug	Conventional Treatment n=13 Participants Metvix® (160mg/g) and Photodynamic Therapy Blue light One session at baseline Metvix® Photodynamic Therapy Blue light: Photodynamic therapy (PDT) is a medical treatment that utilizes a photosensitizing molecule (Metvix) and a blue light source to activate the applied drug
Lesions Disappearance Rate at 6 Months From Baseline.	90.9 percentage of disappeared lesions Standard Deviation 5.9	94.7 percentage of disappeared lesions Standard Deviation 5.4

Adverse Events

Daylight

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Conventional Treatment

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Daylight n=13 participants at risk Metvix® (160mg/g) and Photodynamic Therapy Daylight One session at baseline Metvix® Photodynamic Therapy Daylight: Photodynamic therapy (PDT) is a medical treatment that utilizes a photosensitizing molecule (Metvix) and a the day light to activate the applied drug	Conventional Treatment n=13 participants at risk Metvix® (160mg/g) and Photodynamic Therapy Blue light One session at baseline Metvix® Photodynamic Therapy Blue light: Photodynamic therapy (PDT) is a medical treatment that utilizes a photosensitizing molecule (Metvix) and a blue light source to activate the applied drug
Nervous system disorders Ischaemic stroke	7.7% 1/13 • Number of events 1 • which adverse event data were collected over 6 months	7.7% 1/13 • Number of events 1 • which adverse event data were collected over 6 months

Other adverse events

Adverse event data not reported

Additional Information

Project Manager

CHU de Limoges

Phone: 0555058616

Email: abdeslam.bentaleb@chu-limoges.fr

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place