Phase 3b Study of Metvix NDL-PDT Versus Metvix c-PDT in Subjects With Actinic Keratoses

Phase 3

Completed

• Conditions: Actinic Keratoses
• Interventions: Drug: NDL-PDT; Drug: c-PDT; Drug: placebo c-PDT

• Registration Number: NCT01821391
• Lead Sponsor: Galderma R&D

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-03-27
• Study First Submitted QC: 2013-03-27
• Study First Posted: 2013-04-01
• Study Start: 2013-07
• Primary Completion: 2014-01
• Study Completion: 2014-03
• Status Verified: 2018-02
• Results First Submitted: 2018-02-15
• Results First Submitted QC: 2020-11-16
• Results First Posted: 2020-12-10
• Last Update Submitted: 2021-02-16
• Last Update Posted: 2021-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 131

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NDL-PDT/c-PDT	c-PDT	Metvix natural daylight photodynamic therapy and Metvix conventional photodynamic therapy
NDL-PDT/c-PDT	NDL-PDT	Metvix natural daylight photodynamic therapy and Metvix conventional photodynamic therapy
NDL-PDT/placebo c-PDT	NDL-PDT	Metvix natural daylight photodynamic therapy and Metvix-placebo conventional photodynamic therapy
NDL-PDT/placebo c-PDT	placebo c-PDT	Metvix natural daylight photodynamic therapy and Metvix-placebo conventional photodynamic therapy

Primary Outcome Measures

Name	Time	Method
Percentage (%) Change From Baseline in Total Lesion Complete Response at Week 12 in Group 1	Baseline, Week 12	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).

Trial Locations

Locations (2)

Investigational site; 🇸🇪 Norrköping, Sweden

Investigative site; 🇪🇸 Pamplona, Spain