Intra-individual Comparison of Efficacy and Safety of Metvix® Natural Daylight Photodynamic Therapy Versus Conventional Metvix® Photodynamic Therapy in Subject With Mild Actinic Keratoses (CoMet)

Galderma

Status and phase: Completed; Phase 3

Conditions: Actinic Keratoses

Treatments: Drug: Metvix and natural daylight PDT; Drug: Metvix and conventional PDT

Study type: Interventional

Funder types: Industry

Identifiers

NCT01475071

RD.03.SPR.29102

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 with Aktilite™ lamp in subjects with mild actinic keratoses (intra-individual comparison).

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female above 18 years;
2. Subject with clinical diagnosis of mild AK on the face or the scalp with or without clinical diagnosis of moderate AK on the target areas (TAs);

Exclusion criteria

1. Subject with clinical diagnosis of at least one severe AK on TAs
2. Subject with clinical diagnosis of other skin disease (including non-melanoma skin cancer) on the TAs;
3. Subject with pigmented AK on the TAs

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Metvix and daylight

Experimental group

Treatment:

Drug: Metvix and natural daylight PDT

Metvix and lamp

Active Comparator group

Treatment:

Drug: Metvix and conventional PDT