Early Intervention With Non-ablative Fractional Laser to Reduce Cutaneous Scarring

February 8, 2016 updated by: Katrine Elisabeth Karmisholt, Bispebjerg Hospital
To investigate intervention with early application of non-ablative laser to prevent scarring in the skin

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

To intervene in scar formation at three different time-points

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark
        • Bispebjerg Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • good health
  • men
  • Skin type 2-3
  • non-smokers
  • presenting full medical record

Exclusion Criteria:

  • active skin disease in test area
  • resent UV-exposure in test area
  • history of keloid
  • current or resent cancer
  • uncontrolled systemical disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pre-laser
non-ablative laser Laser Pre-wounding low dose laser Pre-wounding medium dose laser Pre-wounding high dose
Device: non-ablative laser
non-abaltive laser pre, immediate and post wounding
Other Names:
  • Erbium:glass laser
  • 1540 nm laser
Experimental: Immediate-laser
non-ablative laser Laser low dose - immediate after wounding Laser medium dose - immediate after wounding Laser high dose - immediate after wounding
Device: non-ablative laser
non-abaltive laser pre, immediate and post wounding
Other Names:
  • Erbium:glass laser
  • 1540 nm laser
Experimental: Post-laser
non-ablative laser Laser low dose - post wounding Laser medium dose - post wounding Laser medium dose - post wounding
Device: non-ablative laser
non-abaltive laser pre, immediate and post wounding
Other Names:
  • Erbium:glass laser
  • 1540 nm laser
No Intervention: Control
Untreated control wound

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To measure the clinical effect on scarring of non-ablative laser intervention at the three time-points
Time Frame: 3 months after
Clinical evaluation by scar scales
3 months after

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bispebjerg Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

December 30, 2015

First Submitted That Met QC Criteria

December 31, 2015

First Posted (Estimate)

January 5, 2016

Study Record Updates

Last Update Posted (Estimate)

February 9, 2016

Last Update Submitted That Met QC Criteria

February 8, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Early intevention

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cicatrix

Clinical Trials on non-ablative laser

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in China

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe