Status:
COMPLETED
Phase 3b Study of Metvix NDL-PDT Versus Metvix c-PDT in Subjects With Actinic Keratoses
Lead Sponsor:
Galderma R&D
Conditions:
Actinic Keratoses
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study was to be conducted as a multi-centre, randomized, investigator-blinded, active and vehicle-controlled, intra-individual (split-face/scalp) non-inferiority (regarding efficacy) and superior...
Eligibility Criteria
Inclusion
- 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
- 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,
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
131 Patients enrolled
Trial Details
Trial ID
NCT01821391
Start Date
July 1 2013
End Date
March 1 2014
Last Update
February 18 2021
Active Locations (18)
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1
Investigative site
Montpellier, France
2
Investigational site
Nantes, France
3
Investigational site
Nice, France
4
Investigational site
Paris, France