ScarNCT01409863
Fractional Laser Therapy and Dermabrasion for Scar Revision
A study testing laser and standard diamond fraise dermabrasion in people with Scar, run by University of Minnesota.
Trial summary
The goals of this study will be to compare the safety and efficacy of fractional photothermolysis (Fraxel) with dermabrasion when used for scar revision. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Scar
- What is being tested?
- laser and standard diamond fraise dermabrasion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2010to Mar 2010
- 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
- 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 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
About this study
Official title: A Comparison Evaluation of Fractional Laser Therapy an Dermabrasion for Scar Revision
The goals of this study will be to compare the safety and efficacy of fractional photothermolysis (Fraxel) with dermabrasion when used for scar revision.
Read the detailed description
Post traumatic and post surgical scar resurfacing is a common reason for patient visits to dermatologists and plastic surgeons. The Fraxel Laser is a new FDA cleared treatment for textural irregularities of the skin. There have been no studies examining the efficacy of Fraxel specifically for scar resurfacing though it is being used in clinical practice as its clearance was given under hte umbrella of "coagulation of soft tissue." Dermabrasion is the gold standard for scar resurfacing and provides the criterion against which Fraxel therapy should be measured.
- Conditions
- Scar
- Being tested
- laser and standard diamond fraise dermabrasion
- Keywords
- post surgical or post traumatic scar on face or scalp
- Medical subject headings
- Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laser and standard diamond fraise dermabrasionProcedure or surgery
standard dermabrasion, CO2 laser resurfacing
| Study group | Role | What they receive |
|---|---|---|
| laser and standard diamond fraise dermabrasion | No intervention | laser and standard diamond fraise dermabrasion Receives: Procedure: laser and standard diamond fraise dermabrasion |
What is being measured
The primary outcome is the main question the study is designed to answer.
safety and efficacy of fractional photothermolysis
compare the safety and efficacy of fractional photothermolysis (Fraxel) with dermabrasion when used for scar revision.
Measured: Post Surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2011 (estimated)
- Study startMar 2010
- Primary completionMar 2010
- Study completionMar 2010
Why it stopped: PI has left University of Minnesota.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ScarStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John Christophel, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01409863
- Sponsor's protocol ID
- 1001M75732
- Status last verified
- Oct 2023
- First submitted
- 2 Aug 2011
- Last updated
- 4 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison Evaluation of Fractional Laser Therapy an Dermabrasion for Scar Revision
- ClinicalTrials.gov ID
- NCT01409863
- Acronym / sponsor ID
- 1001M75732
- Conditions
- Scar
- Keywords
- post surgical or post traumatic scar on face or scalp
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI has left University of Minnesota.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 4 Aug 2011 (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.
The goals of this study will be to compare the safety and efficacy of fractional photothermolysis (Fraxel) with dermabrasion when used for scar revision.
Detailed description
Post traumatic and post surgical scar resurfacing is a common reason for patient visits to dermatologists and plastic surgeons. The Fraxel Laser is a new FDA cleared treatment for textural irregularities of the skin. There have been no studies examining the efficacy of Fraxel specifically for scar resurfacing though it is being used in clinical practice as its clearance was given under hte umbrella of "coagulation of soft tissue." Dermabrasion is the gold standard for scar resurfacing and provides the criterion against which Fraxel therapy should be measured.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| laser and standard diamond fraise dermabrasion | No intervention | Procedure: laser and standard diamond fraise dermabrasionlaser and standard diamond fraise dermabrasion |
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 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 |
|---|---|---|
| laser and standard diamond fraise dermabrasionstandard dermabrasion, CO2 laser resurfacing | Procedure or surgery | laser and standard diamond fraise dermabrasion |
Primary outcome
safety and efficacy of fractional photothermolysis
Time frame: Post Surgery
compare the safety and efficacy of fractional photothermolysis (Fraxel) with dermabrasion when used for scar revision.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2023.
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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 Christophel, MD principal investigator
University of Minnesota
Questions about this trial
What is this clinical trial studying?
A study testing laser and standard diamond fraise dermabrasion in people with Scar, run by University of Minnesota.
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: withdrawn, as of the sponsor's last update on 4 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
safety and efficacy of fractional photothermolysis (time frame: Post Surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Oct 2023.