Optimizing Uptake of Methylaminolevulinat With Fractional Ablative Laser Technique

Phase 4

Completed

• Conditions: Photodynamic Therapy; Ablative Fractional Laser
• Interventions: Procedure: Laser+Methylaminolevulinat

• Registration Number: NCT01756313
• Lead Sponsor: Bispebjerg Hospital

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 Timeline

• Study Start: 2012-05
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Study First Submitted: 2012-12-20
• Study First Submitted QC: 2012-12-24
• Study First Posted: 2012-12-25
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-25
• Last Update Posted: 2015-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Laser+Methylaminolevulinat	Laser+Methylaminolevulinat	It's a single arm. Intervention as described in the detailed description.

Primary Outcome Measures

Name	Time	Method
Fluorescence Intensity	up to 3 hours	Fluorescence Intensity measured with a fluorescence camera.

Trial Locations

Locations (1)

Department of Dermatology, Bispebjerg Hospital; 🇩🇰 Copenhagen, Denmark