NCT01756313

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. 1.Increases the uptake of Methylaminolevulinat (MAL) in the skin.
  2. 2.Decreases the required incubation time of MAL when performing photo dynamic therapy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started May 2012

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 20, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 25, 2012

Completed
Last Updated

July 28, 2015

Status Verified

July 1, 2015

Enrollment Period

3 months

First QC Date

December 20, 2012

Last Update Submit

July 25, 2015

Conditions

Photodynamic TherapyAblative Fractional Laser

Outcome Measures

Primary Outcomes (1)

  • Fluorescence Intensity

    Fluorescence Intensity measured with a fluorescence camera.

    up to 3 hours

Other Outcomes (1)

  • Skin reactions

    24h

Study Arms (1)

Laser+Methylaminolevulinat

EXPERIMENTAL

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

Procedure: Laser+Methylaminolevulinat

Interventions

Laser+MethylaminolevulinatPROCEDURE

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

Laser+Methylaminolevulinat

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male
  • \>18 years old
  • Fitzpatrick skin type I-III
  • No UV exposure thee months prior to study
  • Signed study consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Dermatology, Bispebjerg Hospital

Copenhagen, DK-2400, Denmark

Location

Study Officials

  • Merete Haedersdal, MD PhD

    Bispebjerg Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

December 20, 2012

First Posted

December 25, 2012

Study Start

May 1, 2012

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

July 28, 2015

Record last verified: 2015-07

Locations

DK(1)