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Optimizing Uptake of Methylaminolevulinat With Fractional Ablative Laser Technique

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01756313
First Posted: December 25, 2012
Last Update Posted: July 28, 2015
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.
Information provided by (Responsible Party):
Christina Haak, Bispebjerg Hospital
  Purpose

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 Intervention Phase
Photodynamic Therapy Ablative Fractional Laser Procedure: Laser+Methylaminolevulinat Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment

Further study details as provided by Christina Haak, Bispebjerg Hospital:

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


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


Enrollment: 12
Study Start Date: May 2012
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01756313


Locations
Denmark
Department of Dermatology, Bispebjerg Hospital
Copenhagen, Denmark, DK-2400
Sponsors and Collaborators
Bispebjerg Hospital
Investigators
Principal Investigator: Merete Haedersdal, MD PhD Bispebjerg Hospital
  More Information

Responsible Party: Christina Haak, MD, Bispebjerg Hospital
ClinicalTrials.gov Identifier: NCT01756313     History of Changes
Other Study ID Numbers: H-4-2012-041
First Submitted: December 20, 2012
First Posted: December 25, 2012
Last Update Posted: July 28, 2015
Last Verified: July 2015