Optimizing Uptake of Methylaminolevulinat With Fractional... | NCT01756313

Studies
Optimizing Uptake of Methylaminolevulinat With Fractional Ablative Laser Technique

NCT01756313

Sponsor

Bispebjerg Hospital

Status

Completed

Last Update Posted

Jul 28, 2015Estimated

Enrollment

12Actual

Phase

Phase 4

Conditions

Photodynamic Therapy
Ablative Fractional Laser

Interventions

Laser+Methylaminolevulinat

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2012

Primary Completion Date

Aug 2012Actual

Completion Date

Aug 2012Actual

First Submitted Date

Dec 20, 2012

First Submission Date that Met QC Criteria

Dec 24, 2012

First Posted Date

Dec 25, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 25, 2015

Last Update Posted Date

Jul 28, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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:

Increases the uptake of Methylaminolevulinat (MAL) in the skin.
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

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
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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Laser+Methylaminolevulinat	Experimental	It's a single arm. Intervention as described in the detailed description.	Procedure: Laser+Methylaminolevulinat

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Laser+Methylaminolevulinat	Procedure	It's a single arm study. Intervention as described in detailed description.	Laser+Methylaminolevulinat

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

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

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Merete Haedersdal, MD PhD	Bispebjerg Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Dermatology, Bispebjerg Hospital		Copenhagen		DK-2400	Denmark