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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01821391
Other study ID # RD.03.SPR.29112
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date July 2013
Est. completion date March 2014

Study information

Verified date February 2018
Source Galderma R&D
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 superiority (regarding pain) study. The primary purpose of this study is to demonstrate the non-inferiority of NDL-PDT compared to c-PDT in terms of lesion complete response rate.


Recruitment information / eligibility

Status Completed
Enrollment 131
Est. completion date March 2014
Est. primary completion date January 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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,

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
NDL-PDT
Metvix natural daylight photodynamic therapy
c-PDT
Metvix conventional photodynamic therapy
placebo c-PDT
Metvix placebo conventional photodynamic therapy

Locations

Country Name City State
France Investigative site Montpellier
France Investigational site Nantes
France Investigational site Nice
France Investigational site Paris
France Investigative site Rennes
Germany Investigational site Aachen
Germany Investigational site Berlin
Germany Investigational site Muenster
Germany Investigational site Recklinghausen
Netherlands Investigational site Assen
Netherlands Investigational site Maastricht
Netherlands Investigational site Nijmegen
Spain Investigational site Huesca
Spain Investigational site Madrid
Spain Investigative site Pamplona
Spain Investigational site Valencia
Sweden Investigational site Karlskoga
Sweden Investigational site Norrköping

Sponsors (1)

Lead Sponsor Collaborator
Galderma R&D

Countries where clinical trial is conducted

France,  Germany,  Netherlands,  Spain,  Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage (%) Change From Baseline in Total Lesion Complete Response at Week 12 in Group 1 The lesion complete response rate was defined as the percentage of pre-existing and treated lesions at Baseline that were assessed as clear (complete disappearance of the lesion, visually and by palpation) at Week 12. New lesions or the lesions in non-complete response were not not considered in the lesion response assessment. This outcome measure was analyzed as an intra-individual comparison between Metvix NDL-PDT on one side of the face/scalp and Metvix vehicle cream (placebo) c-PDT on the contralateral side (Group I). Baseline, Week 12
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