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Safety and Efficacy of Short Incubation MAL-PDT Without Occlusion for Actinic Keratoses
NCT00926952Phase 3
Key facts
- Status
- Completed
- Start
- Jul 2009
- Primary completion
- Dec 2010
- Countries
- 1
- Sponsor
- Innovaderm Research
- Modality
- Light/Condition-Responsive Prodrugs
- Conditions
- actinic keratosis (AK)
01
Overview
Phase 3, open-label, single-arm trial of methyl aminolevulinate in actinic keratosis (AK), sponsored by Innovaderm Research. Primary endpoint: Mean Number of Facial Actinic Keratoses at 12 weeks. Started Jul 2009; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
MAL-PDT 90 min incubation, no occlusion
Methylaminolevulinate cream applied for 90 minutes without occlusion followed by red light PDT.
03
Who it enrols
Adult patients with at least 5 non-hypertrophic actinic keratoses on the face, excluding those with dark skin types (Fitzpatrick IV-VI) or recent treatments.
04
Endpoints
Primary
Mean Number of Facial Actinic Keratoses
Secondary
Number of Patients With Complete Clinical Response of All Actinic Keratoses
Number of Actinic Keratosis Lesions With Complete Clinical Response
Mean Griffiths Photonumeric Scale for Photodamage Score
Mean Fine Wrinkling Score
Mean Coarse Wrinkling Score
Mean Sallowness Score
Mean Mottled Hyperpigmentation
Number of Adverse Events
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