Optimizing Uptake of Methylaminolevulinat With Fractional Ablative Laser Technique

Photodynamic Therapy Clinical Trial

Status Completed

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Endpoint Classification: Bio-availability Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ablative Fractional Laser
• Photodynamic Therapy

• NCT number: NCT01756313
• Study type: Interventional
• Source: Bispebjerg Hospital
• Status: Completed
• Phase: Phase 4
• Start date: May 2012
• Completion date: August 2012