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

Tracking Information
First Submitted Date  ICMJE December 20, 2012
First Posted Date  ICMJE December 25, 2012
Last Update Posted Date July 28, 2015
Study Start Date  ICMJE May 2012
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 24, 2012)
Fluorescence Intensity [ Time Frame: up to 3 hours ]
Fluorescence Intensity measured with a fluorescence camera.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: December 24, 2012)
Skin reactions [ Time Frame: 24h ]
Evaluating skin reactions.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Optimizing Uptake of Methylaminolevulinat With Fractional Ablative Laser Technique
Official Title  ICMJE Not Provided
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.
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Photodynamic Therapy
  • Ablative Fractional Laser
Intervention  ICMJE Procedure: Laser+Methylaminolevulinat
It's a single arm study. Intervention as described in detailed description.
Study Arms  ICMJE Experimental: Laser+Methylaminolevulinat
It's a single arm. Intervention as described in the detailed description.
Intervention: Procedure: Laser+Methylaminolevulinat
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 24, 2012)
12
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2012
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01756313
Other Study ID Numbers  ICMJE H-4-2012-041
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Christina Haak, Bispebjerg Hospital
Study Sponsor  ICMJE Bispebjerg Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Merete Haedersdal, MD PhD Bispebjerg Hospital
PRS Account Bispebjerg Hospital
Verification Date July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP