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Completed

NCT Number: NCT01756313

Optimizing Uptake of Methylaminolevulinat With Fractional Ablative Laser Technique

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.

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Key information

Conditions

Photodynamic Therapy Ablative Fractional Laser

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Department of Dermatology, Bispebjerg Hospital

Copenhagen, DK-2400, Denmark

About this study

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.

  • 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:
  • 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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laser+Methylaminolevulinat

Procedure

It's a single arm study. Intervention as described in detailed description.

Primary outcomes

  1. Fluorescence Intensity

    Time frame: up to 3 hours

    Fluorescence Intensity measured with a fluorescence camera.

Other outcomes

  1. Skin reactions

    Time frame: 24h

    Evaluating skin reactions.

Sponsors and collaborators

Lead sponsor

Bispebjerg Hospital

Other

Registry information

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Dec 25, 2012
Registry last updated
Jul 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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