Optimizing Uptake of Methylaminolevulinat With Fractional Ablative Laser Technique
|ClinicalTrials.gov Identifier: NCT01756313|
Recruitment Status : Completed
First Posted : December 25, 2012
Last Update Posted : July 28, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Photodynamic Therapy Ablative Fractional Laser||Procedure: Laser+Methylaminolevulinat||Phase 4|
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Single (Outcomes Assessor)|
|Study Start Date :||May 2012|
|Primary Completion Date :||August 2012|
|Study Completion Date :||August 2012|
It's a single arm. Intervention as described in the detailed description.
It's a single arm study. Intervention as described in detailed description.
- Fluorescence Intensity [ Time Frame: up to 3 hours ]Fluorescence Intensity measured with a fluorescence camera.
- Skin reactions [ Time Frame: 24h ]Evaluating skin reactions.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01756313
|Department of Dermatology, Bispebjerg Hospital|
|Copenhagen, Denmark, DK-2400|
|Principal Investigator:||Merete Haedersdal, MD PhD||Bispebjerg Hospital|