CicatrixNCT01176448

Laser Resurfacing Versus Dermabrasion for Scar Revision

A study testing Fractionated laser and Dermabrasion in people with Cicatrix and Dermabrasion, run by University of Minnesota at 1 site in United States.

Completed

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

Official record

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Trial summary

Dermabrasion has been the historical standard used for resurfacing scars on the skin. Recently, fractionated laser therapy has been FDA approved for scar resurfacing. This study intends to compare dermabrasion versus fractionated laser therapy for scar resurfacing. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Cicatrix, Dermabrasion, Coagulation, Laser
What is being tested?: Fractionated laser and Dermabrasion
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 6 participants
Where: 1 siteUnited States
Study dates: Apr 2010to Sep 2010
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Post-surgical or post traumatic scar on face or scalp.
Age 18 or older
Able to read and comprehend English
Willing to follow treatment schedule and post treatment care requirements
Signed the informed consent form
Fitzpatrick skin type I-III

Who cannot join

known photosensitivity
Taken any medications known to induce photosensitivity in previous three months
Taken Accutane within past 12 months
Pregnant or nursing
Currently on topical or oral antibiotics
Immunocompromised status
Skin type IV or greater

Trial locations and contacts

1 site in 1 country.

United States1 site

Zel Skin and Laser
Edina, Minnesota, 55424

Other trials in United States

About this study

Official title: A Comparison Evaluation of Fractional Laser Therapy and Dermabrasion for Scar Revision

Conditions: Cicatrix, Dermabrasion, Coagulation, Laser
Being tested: Fractionated laser, Dermabrasion
Keywords: Cicatrix, Dermabrasion, Coagulation, Laser
Medical subject headings: Cicatrix, Thrombosis

What participants receive

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

Fractionated laserDevice
Fractionated laser in the form of the Re:Pair CO2 laser manufactured by Solta Medical.
DermabrasionDevice
Diamond Fraise Dermabrasion will be performed in standard fashion down to papillary dermis.

Study groups in NCT01176448
Study group	Role	What they receive
Fractionated laser	Experimental	This Arm is the section of scar that will be treated with Fractionated Laser Receives: Device: Fractionated laser
Dermabrasion	Active comparator	Dermabrasion is the gold standard for scar resurfacing and will be used as the control against which Fractionated Laser is compared. Receives: Device: Dermabrasion

What is being measured

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

Safey Data Score Based on Ordinal Ratings of Erythema, Edema, Bleeding, Eschar After Resurfacing
Erythema, edema, bleeding, and eschar after resurfacing were used as indicators of safety. Each was judged based on a 4 point ordinal scale 0=absent, 1=mild, 2=moderate, 3=severe.
Measured: Day 0, Week1, Month 1

Secondary outcomes (1)

Visual Analog Scale for Assessing Scar Improvement.
Visual Analog Scale for assessing scar improvement. 0 : Worsening or no improvement
1. : 1-25% improvement
2. : 26-50% improvement
3. : 51-75% improvement
4. : 76-100% improvement
Measured: 3 months

Timeline

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

Apr 2010Sep 2010

First posted6 Aug 2010 (estimated)
Study startApr 2010
Primary completionAug 2010
Study completionSep 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for CicatrixStudies of the same condition, open and under way.
More trials run by University of MinnesotaThe sponsor's other registered studies.
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: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 6 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01176448
Sponsor's protocol ID: 1001M75732-2
Status last verified: Oct 2019
First submitted: 21 Jun 2010
Last updated: 1 Nov 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Jared Christophel J, Elm C, Endrizzi BT, Hilger PA, Zelickson B. A randomized controlled trial of fractional laser therapy and dermabrasion for scar resurfacing. Dermatol Surg. 2012 Apr;38(4):595-602. doi: 10.1111/j.1524-4725.2011.02283.x. Epub 2012 Jan 23.
PubMed 22268699

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

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All Cicatrix trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Comparison Evaluation of Fractional Laser Therapy and Dermabrasion for Scar Revision
ClinicalTrials.gov ID: NCT01176448
Acronym / sponsor ID: 1001M75732-2
Conditions: Cicatrix, Dermabrasion, Coagulation, Laser
Keywords: Cicatrix, Dermabrasion, Coagulation, Laser
Study type: Interventional
Recruitment status: Completed
Enrolment: 6 participants (actual)
Lead sponsor: University of MinnesotaUniversity, hospital or other
Study start: Apr 2010
Primary completion: Aug 2010 (actual)
Study completion: Sep 2010 (actual)
First posted: 6 Aug 2010 (estimated)
Results: Posted 27 Jun 2013

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Fractionated laser	Experimental	Device: Fractionated laserThis Arm is the section of scar that will be treated with Fractionated Laser
Dermabrasion	Active comparator	Device: DermabrasionDermabrasion is the gold standard for scar resurfacing and will be used as the control against which Fractionated Laser is compared.

Who may qualify

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

Key inclusion criteria (6 listed)

Post-surgical or post traumatic scar on face or scalp.
Age 18 or older
Able to read and comprehend English
Willing to follow treatment schedule and post treatment care requirements
Signed the informed consent form

Key exclusion criteria (7 listed)

known photosensitivity
Taken any medications known to induce photosensitivity in previous three months
Taken Accutane within past 12 months
Pregnant or nursing
Currently on topical or oral antibiotics

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
Fractionated laserFractionated laser in the form of the Re:Pair CO2 laser manufactured by Solta Medical.	Device	Fractionated laser
DermabrasionDiamond Fraise Dermabrasion will be performed in standard fashion down to papillary dermis.	Device	Dermabrasion

Primary outcome

Safey Data Score Based on Ordinal Ratings of Erythema, Edema, Bleeding, Eschar After Resurfacing
Time frame: Day 0, Week1, Month 1
Erythema, edema, bleeding, and eschar after resurfacing were used as indicators of safety. Each was judged based on a 4 point ordinal scale 0=absent, 1=mild, 2=moderate, 3=severe.

1 secondary outcome

Visual Analog Scale for Assessing Scar Improvement.
Time frame: 3 months

Results and safety

Results posted to the registry on 27 Jun 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Patients With Scars	6	6

Primary outcome: Safey Data Score Based on Ordinal Ratings of Erythema, Edema, Bleeding, Eschar After Resurfacing

Time frame: Day 0, Week1, Month 1. Mean (Standard Error). Unit: units on a scale

Measure	Fractionated Laser n = 6	Dermabrasion n = 6
Erythema Day 0	1.33 (0.49)	3.00 (0)
Edema Day 0	0 (0)	0 (0)
Bleeding Day 0	1.08 (0.29)	2.0 (0)
Eschar Day 0	0 (0)	0 (0)
Erythema Week 1	0.75 (0.45)	1.50 (0.52)
Edema Week 1	0.17 (0.39)	0.50 (0.52)
Bleeding Week 1	0 (0)	0 (0)
Eschar Week 1	0.08 (0.29)	0.92 (0.79)

Population analysed: Each scar was divided in half and the halves randomized to either Fractionated Laser treatment or Dermabrasion.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Fractionated Laser	0 of 6 (0%)	0 of 6 (0%)	Not reported
Dermabrasion	0 of 6 (0%)	0 of 6 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 22268699Jared Christophel J, Elm C, Endrizzi BT, Hilger PA, Zelickson B. A randomized controlled trial of fractional laser therapy and dermabrasion for scar resurfacing. Dermatol Surg. 2012 Apr;38(4):595-602. doi: 10.1111/j.1524-4725.2011.02283.x. Epub 2012 Jan 23.

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Recruiting
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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.

John J Christophel, MD principal investigator

University of Minnesota

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

Questions about this trial

What is this clinical trial studying?

A study testing Fractionated laser and Dermabrasion in people with Cicatrix and Dermabrasion, run by University of Minnesota at 1 site in United States.

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 6 inclusion and 7 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 1 Nov 2019. 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 United States. 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?

Yes. Results are posted in the registry (first posted 27 Jun 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Safey Data Score Based on Ordinal Ratings of Erythema, Edema, Bleeding, Eschar After Resurfacing (time frame: Day 0, Week1, Month 1). 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 NCT01176448, which also lists 1 linked publication.

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 1 Nov 2019.