ScarNCT05166395
Laser Treated Scars and Optical Coherence Tomography (OCT)
A study testing Er:YAG laser in people with Scar, run by University of Miami at 1 site in United States.
Trial summary
The purpose of this research study is to learn about the effects of the 2940 nm Erbium: Yttrium-Aluminum-Garnet (Er:YAG) laser on treating surgical scar using optical coherence tomography, a medical imaging device. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Scar
- What is being tested?
- Er:YAG laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2024to 1 Dec 2025
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults age 18 years or older
- Patients should have Fitzpatrick skin types of I-IV
- Patients should have mild to severe post-surgical scarring located on head and neck
- Scar lengths of at least 3 cm.
- Ability to understand and the willingness to sign a written informed consent document
Who cannot join
- The patient should not be receiving any additional systemic, topical, or intralesional treatment of the scars during the study
- Scar size less than 3 cm in length
- Pregnant or lactating females
- Fitzpatrick skin type of V-VI
- Scleroderma
- Photosensitivity
- Botulinum toxin injection, facial laser resurfacing, chemical peels, fillers, or usage of oral retinoid within the last 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Surgical Scar With 2940 nm Erbium: Yttrium Aluminum Garnet (YAG) Laser Examined Under Optical Coherence Tomography
The purpose of this research study is to learn about the effects of the 2940 nm Erbium: Yttrium-Aluminum-Garnet (Er:YAG) laser on treating surgical scar using optical coherence tomography, a medical imaging device.
- Conditions
- Scar
- Being tested
- Er:YAG laser
- Keywords
- surgical scar
- Medical subject headings
- Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Er:YAG laserDevice
2940 nm Er:YAG laser treatment spread over 3 sessions within 4 weeks on participant's scar on either the head/neck, trunk or extremities.
| Study group | Role | What they receive |
|---|---|---|
| Er:YAG laser Group | Experimental | The study is a split-scar model. Participants will have half of their lesion receive a total of three sessions using 2940 nm Er:YAG laser spaced over a 4-week study participation interval. Receives: Device: Er:YAG laser |
| Control (No Intervention) Group | No intervention | The study is a split-scar model. Participants will serve as their own control and have half of their lesion receive no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
POSAS Scar Assessment
Patient and Observer Scar Assessment Scale (POSAS) has a total score ranging from 6 (normal skin) to 60 (severely scarred skin).
Measured: Up to 13 weeks
Surgical Scar Blood Flow
As measured using optical coherence tomography
Measured: Up to 13 weeks
Surgical Scar Skin Roughness
As measured using optical coherence tomography
Measured: Up to 13 weeks
Surgical Scar Collagen Content
As measured using optical coherence tomography
Measured: Up to 13 weeks
Surgical Scar Epidermal Thickness
As measured using optical coherence tomography
Measured: Up to 13 weeks
Secondary outcomes (1)
Incidence of Adverse Events
Adverse events reported by participant and evaluated by treating physician
Measured: Up to 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2021
- Study start1 May 2024 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Why it stopped: device not available to initiate study.
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.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Keyvan Nouri, University of Miami
- Investigators
- Keyvan Nouri, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05166395
- Sponsor's protocol ID
- 20190751
- Status last verified
- Feb 2024
- First submitted
- 8 Dec 2021
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Surgical Scar With 2940 nm Erbium: Yttrium Aluminum Garnet (YAG) Laser Examined Under Optical Coherence Tomography
- ClinicalTrials.gov ID
- NCT05166395
- Acronym / sponsor ID
- 20190751
- Conditions
- Scar
- Keywords
- surgical scar
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: device not available to initiate study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 21 Dec 2021 (actual)
- 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 purpose of this research study is to learn about the effects of the 2940 nm Erbium: Yttrium-Aluminum-Garnet (Er:YAG) laser on treating surgical scar using optical coherence tomography, a medical imaging device.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Er:YAG laser Group | Experimental | Device: Er:YAG laserThe study is a split-scar model. Participants will have half of their lesion receive a total of three sessions using 2940 nm Er:YAG laser spaced over a 4-week study participation interval. |
| Control (No Intervention) Group | No intervention | –The study is a split-scar model. Participants will serve as their own control and have half of their lesion receive no intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults age 18 years or older
- Patients should have Fitzpatrick skin types of I-IV
- Patients should have mild to severe post-surgical scarring located on head and neck
- Scar lengths of at least 3 cm.
- Ability to understand and the willingness to sign a written informed consent document
Key exclusion criteria (7 listed)
- The patient should not be receiving any additional systemic, topical, or intralesional treatment of the scars during the study
- Scar size less than 3 cm in length
- Pregnant or lactating females
- Fitzpatrick skin type of V-VI
- Scleroderma
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 |
|---|---|---|
| Er:YAG laser2940 nm Er:YAG laser treatment spread over 3 sessions within 4 weeks on participant's scar on either the head/neck, trunk or extremities. | Device | Er:YAG laser Group |
Primary outcome
POSAS Scar Assessment
Time frame: Up to 13 weeks
Patient and Observer Scar Assessment Scale (POSAS) has a total score ranging from 6 (normal skin) to 60 (severely scarred skin).
Surgical Scar Blood Flow
Time frame: Up to 13 weeks
As measured using optical coherence tomography
Surgical Scar Skin Roughness
Time frame: Up to 13 weeks
As measured using optical coherence tomography
Surgical Scar Collagen Content
Time frame: Up to 13 weeks
As measured using optical coherence tomography
Surgical Scar Epidermal Thickness
Time frame: Up to 13 weeks
As measured using optical coherence tomography
1 secondary outcome
Incidence of Adverse Events
Time frame: Up to 13 weeks
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 20 Feb 2024.
- Individual participant dataSharing planned: No
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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.
Keyvan Nouri, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Er:YAG laser in people with Scar, run by University of Miami 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 5 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 20 Feb 2024. 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?
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?
POSAS Scar Assessment (time frame: Up to 13 weeks). The study lists 5 primary outcomes in all. 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 20 Feb 2024.