Optimizing Uptake of Methylaminolevulinat With Fractional Ablative Laser Technique

NCT ID: NCT01756313

Last Updated: 2015-07-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2012-08-31

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

Conditions

Photodynamic Therapy; Ablative Fractional Laser

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Laser+Methylaminolevulinat

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

Group Type: EXPERIMENTAL

Laser+Methylaminolevulinat

Intervention Type: PROCEDURE

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

Interventions

Laser+Methylaminolevulinat

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Bispebjerg Hospital

OTHER

Sponsor Role: lead

Responsible Party

Christina Haak

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Merete Haedersdal, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Bispebjerg Hospital

Locations

Department of Dermatology, Bispebjerg Hospital

Copenhagen, , Denmark

Countries

Denmark

Other Identifiers

H-4-2012-041

Identifier Type: -

Identifier Source: org_study_id