NCT01756313

Optimizing Uptake of Methylaminolevulinat With Fractional Ablative Laser Technique

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Bispebjerg Hospital · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The objectives of this study is to investigate if pre-treating the skin with an ablative fractional laser that creates small micropores in the skin: 1. Increases the uptake of Methylaminolevulinat (MAL) in the skin. 2. Decreases the required incubation time of MAL when performing photo dynamic therapy.

Detailed description

12 healthy male individuals were included. On the back, 25 areas measuring 2.8x2.8 cm were marked, plus one control area. We tested 2 variables. 1\) Density of laser channels. 2) Methylaminolevulinat (MAL) concentration 1. Laser - Each area was randomized to receiving: * no treatment * 1% laser channel density * 2% laser channel density * 5% laser channel density * 10% laser channel density * 15% laser channel density 2. MAL - Each density was assigned to 4 areas. Within each density category, the four areas were randomized to receive: * vehicle * 4% MAL * 8%MAL * 16%MAL The uptake of MAL was evaluated by fluorescence intensity measured with a florescence camera at t= * 0min * 30min * 1h * 1.5h 2h 2.5h 3h

Conditions

• Photodynamic Therapy
• Ablative Fractional Laser

Interventions

Type	Name	Description
PROCEDURE	Laser+Methylaminolevulinat	It's a single arm study. Intervention as described in detailed description.

Timeline

• Start date: 2012-05-01
• Primary completion: 2012-08-01
• Completion: 2012-08-01
• First posted: 2012-12-25
• Last updated: 2015-07-28

Locations

1 site across 1 country: Denmark