Actinic Keratoses Treatment With Metvix® in Combination With Light

Phase 3

Completed

• Conditions: Actinic Keratoses
• Interventions: Drug: Metvix®; Procedure: Photodynamic Therapy Daylight; Procedure: Photodynamic Therapy Blue light

• Registration Number: NCT02373371
• Lead Sponsor: University Hospital, Limoges

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)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-02-16
• Study First Submitted QC: 2015-02-26
• Study First Posted: 2015-02-27
• Study Start: 2015-03-25
• Primary Completion: 2016-11-22
• Study Completion: 2018-06-01
• Status Verified: 2018-08
• Results First Submitted: 2019-01-09
• Results First Submitted QC: 2019-01-09
• Last Update Submitted: 2019-01-09
• Results First Posted: 2019-04-08
• Last Update Posted: 2019-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

• 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);

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Daylight	Metvix®	Metvix® (160mg/g) and Photodynamic Therapy Daylight One session at baseline
Daylight	Photodynamic Therapy Daylight	Metvix® (160mg/g) and Photodynamic Therapy Daylight One session at baseline
Conventional treatment	Metvix®	Metvix® (160mg/g) and Photodynamic Therapy Blue light One session at baseline
Conventional treatment	Photodynamic Therapy Blue light	Metvix® (160mg/g) and Photodynamic Therapy Blue light One session at baseline

Primary Outcome Measures

Name	Time	Method
Mean Change From Baseline in Total Number of Treated Mild Lesions Per Side at Week 12	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.

Secondary Outcome Measures

Name	Time	Method
Pain Assesment	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).
Lesions Disappearance Rate at 1 Months From Baseline.	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
Lesions Disappearance Rate at 6 Months From Baseline.	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

Trial Locations

Locations (1)

Limoges University Hospital; 🇫🇷 Limoges, France