Trial Information
Multi-centre, Randomized, Investigator-blind, Intra-individual Active and Vehicle-controlled Study, Comparing Metvix Natural Daylight Photodynamic Therapy Versus Metvix Conventional Photodynamic Therapy in Subjects With Actinic Keratosis
Inclusion Criteria:
- Clinical diagnosis of mild (Grade 1) and/or moderate (Grade 2) AKs on the face or the
scalp on treated areas
- Subject with two symmetrical treated areas half scalps or two half faces excluding
ears, chin, bridge of the nose, eyelids and lips inside the vermillion border): no
more than a twofold difference in terms of total number of lesions between the two
TAs
Exclusion Criteria:
- Subject with clinical diagnosis of at least one severe (Grade 3) AK on treated areas
- Subject with pigmented AK on the treated areas
- Immuno-compromised Subject for idiopathic, disease specific or therapeutic reasons
- Subject with porphyria,
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Outcome Measure:
lesion response
Outcome Description:
percent of lesions treated at baseline in complete response at week 12
Outcome Time Frame:
week 12
Safety Issue:
No
Principal Investigator
Nicole Basset Seguin, PhD, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Hopital Saint Louis France
Authority:
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Study ID:
RD.03.SPR.29112
NCT ID:
NCT01821391
Start Date:
July 2013
Completion Date:
February 2014
Related Keywords:
- Actinic Keratoses
- actinic keratoses
- photodynamic therapy
- natural daylight
- Keratosis
- Keratosis, Actinic