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

NCT ID: NCT02645773

Last Updated: 2016-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2016-01-31

Brief Summary

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

Detailed Description

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To intervene in scar formation at three different time-points

Conditions

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Cicatrix

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Pre-laser

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

Group Type EXPERIMENTAL

non-ablative laser

Intervention Type DEVICE

non-abaltive laser pre, immediate and post wounding

Immediate-laser

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

Group Type EXPERIMENTAL

non-ablative laser

Intervention Type DEVICE

non-abaltive laser pre, immediate and post wounding

Post-laser

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

Group Type EXPERIMENTAL

non-ablative laser

Intervention Type DEVICE

non-abaltive laser pre, immediate and post wounding

Control

Untreated control wound

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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non-ablative laser

non-abaltive laser pre, immediate and post wounding

Intervention Type DEVICE

Other Intervention Names

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Erbium:glass laser 1540 nm laser

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Bispebjerg Hospital

OTHER

Sponsor Role lead

Responsible Party

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Katrine Elisabeth Karmisholt

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Merete Haedersdal, professor

Role: PRINCIPAL_INVESTIGATOR

Bispebjerg Hospital

Locations

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Bispebjerg Hospital

Copenhagen, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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Early intevention

Identifier Type: -

Identifier Source: org_study_id

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