Optimizing Uptake of Methylaminolevulinat With Fractional Ablative Laser Technique

Photodynamic Therapy Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01756313
• Other study ID #: H-4-2012-041
• Status: Completed
• Phase: Phase 4
• First received: December 20, 2012
• Last updated: July 25, 2015
• Start date: May 2012
• Est. completion date: August 2012

Study information

• Verified date: July 2015
• Source: Bispebjerg Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The National Committee on Health Research Ethics
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Bio-availability Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ablative Fractional Laser
• Photodynamic Therapy

Intervention

Procedure:
• Laser+Methylaminolevulinat
It's a single arm study. Intervention as described in detailed description.

Locations

Country	Name	City	State
Denmark	Department of Dermatology, Bispebjerg Hospital	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Bispebjerg Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Skin reactions	Evaluating skin reactions.	24h	Yes
Primary	Fluorescence Intensity	Fluorescence Intensity measured with a fluorescence camera.	up to 3 hours	No