Optimizing Uptake of Methylaminolevulinat With Fractional Ablative Laser Technique
Recruitment status was Active, not recruiting
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:
- Increases the uptake of Methylaminolevulinat (MAL) in the skin.
- Decreases the required incubation time of MAL when performing photo dynamic therapy.
Photo Dynamic Therapy
Ablative Fractional Laser
|Study Design:||Endpoint Classification: Bio-availability Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
- Fluorescence Intensity [ Time Frame: up to 3 hours ] [ Designated as safety issue: No ]Fluorescence Intensity measured with a fluorescence camera.
- Skin reactions [ Time Frame: 24h ] [ Designated as safety issue: Yes ]Evaluating skin reactions.
|Study Start Date:||May 2012|
|Estimated Study Completion Date:||May 2013|
|Estimated Primary Completion Date:||May 2013 (Final data collection date for primary outcome measure)|
It's a single arm. Intervention as described in the detailed description.
It's a single arm study. Intervention as described in 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
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
MAL - Each density was assigned to 4 areas. Within each density category, the four areas were randomized to receive:
- 4% MAL
The uptake of MAL was evaluated by fluorescence intensity measured with a florescence camera at t=
- 1.5h 2h 2.5h 3h
Please refer to this study by its ClinicalTrials.gov identifier: NCT01756313
|Department of Dermatology, Bispebjerg Hospital|
|Copenhagen, Denmark, DK-2400|
|Principal Investigator:||Merete Haedersdal, MD PhD||Bispebjerg Hospital|