CicatrixNCT02645773

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

A study testing non-ablative laser in people with Cicatrix, run by Bispebjerg Hospital at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

To investigate intervention with early application of non-ablative laser to prevent scarring in the skin Read more about this study

Who is it for?: Ages 18 years and older, men onlyHealthy volunteers can take part
Conditions the study is for: Cicatrix
What is being tested?: non-ablative laser
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 1 siteDenmark
Study dates: Sep 2015to Jan 2016
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Men only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Denmark1 site

Bispebjerg Hospital
Copenhagen

Other trials in Denmark

About this study

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

Read the detailed description

To intervene in scar formation at three different time-points

Conditions: Cicatrix
Being tested: non-ablative laser
Medical subject headings: Cicatrix

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

non-ablative laserDevice
Also called Erbium:glass laser, 1540 nm laser
non-abaltive laser pre, immediate and post wounding

Study groups in NCT02645773
Study group	Role	What they receive
Pre-laser	Experimental	non-ablative laser Laser Pre-wounding low dose laser Pre-wounding medium dose laser Pre-wounding high dose Receives: 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 Receives: 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 Receives: Device: non-ablative laser
Control	No intervention	Untreated control wound

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2015Jan 2016

First posted5 Jan 2016 (estimated)
Study startSep 2015
Primary completionDec 2015
Study completionJan 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for CicatrixStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02645773
Sponsor's protocol ID: Early intevention
Status last verified: Feb 2016
First submitted: 30 Dec 2015
Last updated: 9 Feb 2016
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter
Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation
Active, not recruitingPhase 1/2
A Study to Evaluate ALN-CIDEB in Adult Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease or With Metabolic Dysfunction-Associated Steatohepatitis (MASLD/MASH)
Metabolic Dysfunction-Associated Steatotic Liver Disease, Metabolic Dysfunction-Associated Steatohepatitis
Recruiting
Clinical Impact of Uterine Repair During Cesarean Section With Barbed Suture on the Incidence of Isthmocele
Isthmocele, Cesarean Scar Defect
RecruitingPhase 2
Tirzepatide for Treatment of CCCA
Central Centrifugal Cicatricial Alopecia (CCCA)
Recruiting
Surgical Outcomes of Simple Interrupted Versus Running Epidermal Sutures in Full-thickness Skin Graft Placement
Skin Graft Scar

All Cicatrix trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Early Intervention With Non-ablative Fractional Laser to Reduce Cutaneous Scarring
ClinicalTrials.gov ID: NCT02645773
Acronym / sponsor ID: Early intevention
Conditions: Cicatrix
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: Bispebjerg HospitalUniversity, hospital or other
Study start: Sep 2015
Primary completion: Dec 2015 (actual)
Study completion: Jan 2016 (actual)
First posted: 5 Jan 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Pre-laser	Experimental	Device: non-ablative lasernon-ablative laser Laser Pre-wounding low dose laser Pre-wounding medium dose laser Pre-wounding high dose
Immediate-laser	Experimental	Device: non-ablative lasernon-ablative laser Laser low dose - immediate after wounding Laser medium dose - immediate after wounding Laser high dose - immediate after wounding
Post-laser	Experimental	Device: non-ablative lasernon-ablative laser Laser low dose - post wounding Laser medium dose - post wounding Laser medium dose - post wounding
Control	No intervention	–Untreated control wound

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
non-ablative laserAlso: Erbium:glass laser, 1540 nm lasernon-abaltive laser pre, immediate and post wounding	Device	Immediate-laser, Post-laser, Pre-laser

Primary outcome

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2016.

Related trials for Cicatrix

Recruiting
A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter
Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation
Active, not recruitingPhase 1/2
A Study to Evaluate ALN-CIDEB in Adult Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease or With Metabolic Dysfunction-Associated Steatohepatitis (MASLD/MASH)
Metabolic Dysfunction-Associated Steatotic Liver Disease, Metabolic Dysfunction-Associated Steatohepatitis
Recruiting
Clinical Impact of Uterine Repair During Cesarean Section With Barbed Suture on the Incidence of Isthmocele
Isthmocele, Cesarean Scar Defect
RecruitingPhase 2
Tirzepatide for Treatment of CCCA
Central Centrifugal Cicatricial Alopecia (CCCA)
Recruiting
Surgical Outcomes of Simple Interrupted Versus Running Epidermal Sutures in Full-thickness Skin Graft Placement
Skin Graft Scar

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Merete Haedersdal, professor principal investigator

Bispebjerg Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing non-ablative laser in people with Cicatrix, run by Bispebjerg Hospital at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To measure the clinical effect on scarring of non-ablative laser intervention at the three time-points (time frame: 3 months after). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02645773.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2016.