Optimizing Uptake of Methylaminolevulinat With Fractional Ablative Laser Technique

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01756313

Enrollment

Registered

2012-12-25

Start date

2012-05-31

Completion date

2012-08-31

Last updated

2015-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ablative Fractional Laser, Photodynamic Therapy

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

Interventions

PROCEDURELaser+Methylaminolevulinat

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Fluorescence Intensity	up to 3 hours	Fluorescence Intensity measured with a fluorescence camera.

Other

Measure	Time frame	Description
Skin reactions	24h	Evaluating skin reactions.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026