Intra-individual Comparison of Efficacy and Safety of Metvix® Natural Daylight Photodynamic Therapy Versus Conventional Metvix® Photodynamic Therapy in Subject With Mild Actinic Keratoses

Phase 3

Completed

• Conditions: Actinic Keratoses
• Interventions: Drug: Metvix and conventional PDT; Drug: Metvix and natural daylight PDT

• Registration Number: NCT01475071
• Lead Sponsor: Galderma R&D

Brief Summary

The main objective of this study is to compare efficacy and safety of Metvix® natural daylight photodynamic therapy with those of Metvix® conventional photodynamic therapy with Aktilite™ lamp in subjects with mild actinic keratoses (intra-individual comparison).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-10-27
• Study First Submitted QC: 2011-11-16
• Study First Posted: 2011-11-21
• Study Start: 2012-03
• Primary Completion: 2012-11
• Study Completion: 2013-03
• Results First Submitted: 2013-08-29
• Status Verified: 2016-03
• Results First Submitted QC: 2016-03-17
• Results First Posted: 2016-04-18
• Last Update Submitted: 2021-02-16
• Last Update Posted: 2021-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Male or female above 18 years;
2. Subject with clinical diagnosis of mild AK on the face or the scalp with or without clinical diagnosis of moderate AK on the target areas (TAs);

Exclusion Criteria

1. Subject with clinical diagnosis of at least one severe AK on TAs
2. Subject with clinical diagnosis of other skin disease (including non-melanoma skin cancer) on the TAs;
3. Subject with pigmented AK on the TAs

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Metvix and lamp	Metvix and conventional PDT	-
Metvix and daylight	Metvix and natural daylight PDT	-

Primary Outcome Measures

Name	Time	Method
Lesion Response	Week12	Percent of lesions treated at Baseline, in complete response at Week 12
Pain Score	Baseline (during procedure), assessed after procedure	Subject self assessment of pain on a scale from 0 (no pain ) to 10 (extreme pain)

Trial Locations

Locations (2)

Galderma Investigational site; 🇦🇺 Carlton, Victoria, Australia

Galderma Investigational Site; 🇦🇺 Kogarah, New South Wales, Australia