Optimizing Uptake of Methylaminolevulinat With Fractional Ablative Laser Technique

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Christina Haak, Bispebjerg Hospital
ClinicalTrials.gov Identifier:
NCT01756313
First received: December 20, 2012
Last updated: December 24, 2012
Last verified: May 2012
  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
Photo Dynamic Therapy
Ablative Fractional Laser
Procedure: Laser+Methylaminolevulinat
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Bio-availability Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Further study details as provided by Bispebjerg Hospital:

Primary Outcome Measures:
  • Fluorescence Intensity [ Time Frame: up to 3 hours ] [ Designated as safety issue: No ]
    Fluorescence Intensity measured with a fluorescence camera.


Other Outcome Measures:
  • Skin reactions [ Time Frame: 24h ] [ Designated as safety issue: Yes ]
    Evaluating skin reactions.


Estimated Enrollment: 12
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)
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

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Christina Haak, MD, Bispebjerg Hospital
ClinicalTrials.gov Identifier: NCT01756313     History of Changes
Other Study ID Numbers: H-4-2012-041
Study First Received: December 20, 2012
Last Updated: December 24, 2012
Health Authority: DENMARK:The National Committee on Health Research Ethics

ClinicalTrials.gov processed this record on April 15, 2014