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

Primary Purpose

Cicatrix

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
non-ablative laser
Sponsored by
Bispebjerg Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cicatrix

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Bispebjerg Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

Pre-laser

Immediate-laser

Post-laser

Control

Arm Description

non-ablative laser Laser Pre-wounding low dose laser Pre-wounding medium dose laser Pre-wounding high dose

non-ablative laser Laser low dose - immediate after wounding Laser medium dose - immediate after wounding Laser high dose - immediate after wounding

non-ablative laser Laser low dose - post wounding Laser medium dose - post wounding Laser medium dose - post wounding

Untreated control wound

Outcomes

Primary Outcome Measures

To measure the clinical effect on scarring of non-ablative laser intervention at the three time-points
Clinical evaluation by scar scales

Secondary Outcome Measures

Full Information

First Posted
December 30, 2015
Last Updated
February 8, 2016
Sponsor
Bispebjerg Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02645773
Brief Title
Early Intervention With Non-ablative Fractional Laser to Reduce Cutaneous Scarring
Official Title
Early Intervention With Non-ablative Fractional Laser to Reduce Cutaneous Scarring
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bispebjerg Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To investigate intervention with early application of non-ablative laser to prevent scarring in the skin
Detailed Description
To intervene in scar formation at three different time-points

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cicatrix

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pre-laser
Arm Type
Experimental
Arm Description
non-ablative laser Laser Pre-wounding low dose laser Pre-wounding medium dose laser Pre-wounding high dose
Arm Title
Immediate-laser
Arm Type
Experimental
Arm Description
non-ablative laser Laser low dose - immediate after wounding Laser medium dose - immediate after wounding Laser high dose - immediate after wounding
Arm Title
Post-laser
Arm Type
Experimental
Arm Description
non-ablative laser Laser low dose - post wounding Laser medium dose - post wounding Laser medium dose - post wounding
Arm Title
Control
Arm Type
No Intervention
Arm Description
Untreated control wound
Intervention Type
Device
Intervention Name(s)
non-ablative laser
Other Intervention Name(s)
Erbium:glass laser, 1540 nm laser
Intervention Description
non-abaltive laser pre, immediate and post wounding
Primary Outcome Measure Information:
Title
To measure the clinical effect on scarring of non-ablative laser intervention at the three time-points
Description
Clinical evaluation by scar scales
Time Frame
3 months after

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Merete Haedersdal, professor
Organizational Affiliation
Bispebjerg Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bispebjerg Hospital
City
Copenhagen
Country
Denmark

12. IPD Sharing Statement

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

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