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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. Identifier: NCT01756313
Recruitment Status : Completed
First Posted : December 25, 2012
Last Update Posted : July 28, 2015
Information provided by (Responsible Party):
Christina Haak, Bispebjerg Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Photodynamic Therapy Ablative Fractional Laser Procedure: Laser+Methylaminolevulinat Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : May 2012
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

Arm Intervention/treatment
Experimental: Laser+Methylaminolevulinat
It's a single arm. Intervention as described in the detailed description.
Procedure: Laser+Methylaminolevulinat
It's a single arm study. Intervention as described in detailed description.

Primary Outcome Measures :
  1. Fluorescence Intensity [ Time Frame: up to 3 hours ]
    Fluorescence Intensity measured with a fluorescence camera.

Other Outcome Measures:
  1. Skin reactions [ Time Frame: 24h ]
    Evaluating skin reactions.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Male
  • >18 years old
  • Fitzpatrick skin type I-III
  • No UV exposure thee months prior to study
  • Signed study consent

Exclusion Criteria:

  • Known allergy to substances in MAL or Unguentum M cream.
  • Previous keloid
  • Use of topical or systemic photosensitizing drug
  • Evaluated to not be able to follow treatment protocol

Information from the National Library of Medicine

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 identifier (NCT number): NCT01756313

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Department of Dermatology, Bispebjerg Hospital
Copenhagen, Denmark, DK-2400
Sponsors and Collaborators
Bispebjerg Hospital
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Principal Investigator: Merete Haedersdal, MD PhD Bispebjerg Hospital
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Responsible Party: Christina Haak, MD, Bispebjerg Hospital Identifier: NCT01756313    
Other Study ID Numbers: H-4-2012-041
First Posted: December 25, 2012    Key Record Dates
Last Update Posted: July 28, 2015
Last Verified: July 2015