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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


Phase 3
18 Years
N/A
Not Enrolling
Both
Actinic Keratoses

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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

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