Actinic Keratoses Treatment With Metvix® in Combination With Light

University of Limoges (UL)

Status and phase: Completed; Phase 3

Conditions: Actinic Keratoses

Treatments: Procedure: Photodynamic Therapy Daylight; Drug: Metvix®; Procedure: Photodynamic Therapy Blue light

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02373371

I14034

Details and patient eligibility

About

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)

Enrollment: 26 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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26 participants in 2 patient groups

Daylight

Experimental group

Description:

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

Treatment:

Drug: Metvix®

Procedure: Photodynamic Therapy Daylight

Conventional treatment

Active Comparator group

Description:

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

Treatment:

Drug: Metvix®

Procedure: Photodynamic Therapy Blue light