Optimizing Uptake of Methylaminolevulinat With Fractional Ablative Laser Technique

Bispebjerg Hospital

Status and phase: Completed; Phase 4

Conditions: Photodynamic Therapy; Ablative Fractional Laser

Treatments: Procedure: Laser+Methylaminolevulinat

Study type: Interventional

Funder types: Other

Identifiers

NCT01756313

H-4-2012-041

Details and patient eligibility

About

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.

Full 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

Enrollment: 12 patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Single Blind

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12 participants in 1 patient group

Laser+Methylaminolevulinat

Experimental group

Description:

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

Treatment:

Procedure: Laser+Methylaminolevulinat