Optimizing Uptake of Methylaminolevulinat With Fractional Ablative Laser Technique
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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|
|Actual Primary Completion Date :||August 2012|
|Actual 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|