NCT01053000

Photodynamic Therapy With Levulan® +/- Topical Retinoid Pre-Treatment In The Treatment Of Actinic Keratoses

Photodynamic Therapy With Levulan® Topical Solution And Blue Light +/- Topical Retinoid Pre-Treatment In The Treatment Of Dorsal Hand/Forearm Actinic Keratoses

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Stewart, Roger H., M.D., P.A. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To determine and compare the safety and efficacy of broad area photodynamic therapy with aminolevulinic acid (ALA-PDT) following topical retinoid pre-treatment vs ALA-PDT with occlusion only (no pretreatment) in subjects with dorsal hand/forearm actinic keratoses, with an incubation time of 60 minutes, using blue light.

Detailed description

Subjects will be randomized such that their RIGHT dorsal hand/forearm will receive one of the following two treatments with the subject's LEFT dorsal hand/forearm receiving the other treatment; Treatment 1 will include pre-treatment of the dorsal hand/forearm with Tazorac 0.1% gel BID for one week, followed by ALA applied to the entire dorsal hand/forearm 60 minutes prior to BLUE light treatment for 16 minutes 40 seconds Treatment 2 will have ALA applied to the entire dorsal hand/forearm and occluded for 60 minutes prior to BLUE light treatment for 16 minutes 40 secondsNote: ALA will be applied to individual dorsal hand/forearm actinic keratoses (AK) lesions followed by broad area application over the entire dorsal hand/forearm surface. The treatment area on the side NOT pre-treated with Tazorac will then be occluded using plastic wrap for 60 minutes. The treatment area of the dorsal hand/forearm is defined as the extensor surface of the hand/forearm between the elbow and the base of the fingers (the fingers are NOT included in the treatment area).

Conditions

• ACTINIC KERATOSES

Interventions

Type	Name	Description
DRUG	Tazorac	compare the safety and efficacy of broad area photodynamic therapy with aminolevulinic acid (ALA-PDT) following topical retinoid pre-treatment with Tazorac vs ALA-PDT with occlusion only (no pretreatment) in subjects with dorsal hand/forearm actinic keratoses, with an incubation time of 60 minutes, using blue light.

Timeline

• Start date: 2010-01-01
• Primary completion: 2010-11-01
• Completion: 2010-11-01
• First posted: 2010-01-21
• Last updated: 2015-08-11
• Results posted: 2015-07-22

Locations

1 site across 1 country: United States