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Short Incubation Methylaminolevulinate Photodynamic Therapy Without Occlusion

NCT00926952 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2011-09-09

Study results available
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Summary

Actinic keratoses on the face are often numerous and widespread. The application of Methylaminolevulinate (MAL) on individual lesions followed by the application of a plastic film on each lesion is difficult and takes time for subjects with many actinic keratoses. The waiting period of 3 hours between MAL cream application and red light exposure is also long for patients. The goal of this study is to evaluate the safety and efficacy of photodynamic therapy (PDT) with MAL with a shorter cream application time (90 minutes) and when MAL is applied on the entire face without the plastic film.

Conditions

  • Actinic Keratosis

Interventions

DRUG

Methylaminolevulinate (Metvix, Metvixia)

2-4 g of cream applied to entire face at Day 0 for 90 minutes without occlusion prior to light treatment. If any actinic keratoses remained after 4 weeks the treatment was repeated at Week 4.

DEVICE

Photodynamic Therapy (Aktilite)

Device set to 37 J/cm². Red light wavelength is approximately 630 nm.

Sponsors & Collaborators

  • Galderma Canada

    collaborator OTHER

  • Innovaderm Research Inc.

    lead OTHER

Principal Investigators

  • Robert Bissonnette, MD, FRCPC · Innovaderm Research

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2010-12-31
Completion
2011-01-31

Countries

  • Canada

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00926952 on ClinicalTrials.gov