NCT02645773

Brief Summary

To investigate intervention with early application of non-ablative laser to prevent scarring in the skin

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2015

Shorter than P25 for not_applicable

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

September 1, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

December 30, 2015

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 5, 2016

Completed
Last Updated

February 9, 2016

Status Verified

February 1, 2016

Enrollment Period

3 months

First QC Date

December 30, 2015

Last Update Submit

February 8, 2016

Conditions

Cicatrix

Outcome Measures

Primary Outcomes (1)

  • To measure the clinical effect on scarring of non-ablative laser intervention at the three time-points

    Clinical evaluation by scar scales

    3 months after

Study Arms (4)

Pre-laser

EXPERIMENTAL

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

Device: non-ablative laser

Immediate-laser

EXPERIMENTAL

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

Post-laser

EXPERIMENTAL

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

Device: non-ablative laser

Control

NO INTERVENTION

Untreated control wound

Interventions

non-ablative laserDEVICE

non-abaltive laser pre, immediate and post wounding

Also known as: Erbium:glass laser, 1540 nm laser
Immediate-laserPost-laserPre-laser

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bispebjerg Hospital

Copenhagen, Denmark

Location

MeSH Terms

Conditions

Cicatrix

Interventions

Lasers

Condition Hierarchy (Ancestors)

FibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Optical DevicesEquipment and SuppliesRadiation Equipment and Supplies

Study Officials

  • Merete Haedersdal, professor

    Bispebjerg Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

December 30, 2015

First Posted

January 5, 2016

Study Start

September 1, 2015

Primary Completion

December 1, 2015

Study Completion

January 1, 2016

Last Updated

February 9, 2016

Record last verified: 2016-02

Locations

DK(1)