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Scars After Surgical InterventionNCT07037264

A Study of the Efficacy and Safety of Non-ablative Fractional Laser in the Treatment of Thyroidectomy Scars

A study testing Non-ablative fractional laser treatment in people with Scars After Surgical Intervention, run by Chinese Medical Association at 1 site in China.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

The subject's neck thyroidectomy incision was bisected along the anterior midline. One side received 1565 nm non-ablative fractional laser treatment, designated as the study side, according to a computer-generated randomization scheme, while the other side received a sham treatment (the laser device emitted sound… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Scars After Surgical Intervention
What is being tested?
Non-ablative fractional laser treatment
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteChina
Study dates
1 Sep 2024to 1 Mar 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The patient is conscious, with no intellectual disability or cognitive difficulties, and understands and signs the informed consent form.
  • Healthy male and female subjects aged 18 to 70 years.
  • Fitzpatrick skin types I to V.
  • Women of childbearing age have used contraceptive measures within three months before enrollment.
  • The patient has undergone traditional thyroidectomy through the anterior neck approach within 15 days, with a surgical incision visible in the midline of the neck, symmetric along the anterior midline of the body surface; or the patient has undergone traditional thyroidectomy through the anterior neck approach within one year, with a linear hypertrophic surgical scar visible in the midline of the neck, symmetric along the anterior midline of the body surface.
  • The patient is able to comply with all the plans and requirements for visits, treatments, and assessments.requirements.

Who cannot join

  • Need for modified radical neck dissection or reoperation, or other surgical plans that may affect treatment and follow-up during the trial period;
  • Previous neck surgery;
  • Pregnant, planning to become pregnant during the study period, less than three months postpartum, or less than six weeks after completing breastfeeding;
  • History of keloid or delayed wound healing;
  • Uncontrolled systemic diseases;
  • History of mental disorders;
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  • Presence of skin tumors or skin inflammation in the treatment area;
  • Active infection in the neck area or systemic infection;
  • Use of oral photosensitizing drugs or retinoids within six months before screening;
  • Use of anticoagulants, corticosteroids, immunosuppressants, or other drug treatments within three months before screening;
  • Exposure to strong ultraviolet radiation causing desquamation, erythema, or other conditions in the neck within one month before screening;
  • Participation in other drug/medical device clinical trials within one month before screening or planned participation during the study period;
  • Use of any other treatment methods for post-thyroidectomy scars except for silicone gel sheets and topical drugs before and during treatment;
  • Use of silicone gel sheets and topical drugs for post-thyroidectomy scars within seven days before starting treatment;
  • Patients allergic to compound lidocaine cream or its components, and no alternative to this drug is available;
  • Patients who, in the investigator's opinion, have other conditions that may affect compliance or are not suitable for participating in this study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site

  • Chinese PLA Genaral Hosptial

    Beijing, Beijing Municipality, 100853

Other trials in China

About this study

The subject's neck thyroidectomy incision was bisected along the anterior midline. One side received 1565 nm non-ablative fractional laser treatment, designated as the study side, according to a computer-generated randomization scheme, while the other side received a sham treatment (the laser device emitted sound only, without delivering any energy), serving as the control side. Outcome indicators were recorded during follow-up, along with any related adverse events and/or reactions occurring during and after the treatment. The aim was to evaluate the effectiveness and safety of the 1565 nm non-ablative fractional laser in the treatment of postoperative thyroid scars.

Being tested
Non-ablative fractional laser treatment

What participants receive

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

  • Non-ablative fractional laser treatmentDevice

    The entire scar area is sealed with local anesthetic for 60 minutes before laser treatment. Give the study side 1565 nm non-ablative fractional laser treatment, spot diameter 10～16 mm, energy 40～45 mJ/cm2, spot density 150～200/cm2,1~2passes.

Study groups in NCT07037264
Study groupRoleWhat they receive
Non-ablative fractional laser treatmentExperimentalNot described
Receives: Device: Non-ablative fractional laser treatment

What is being measured

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

  1. The depth of scar echoes

    Using the high-frequency skin ultrasound MD-300SⅡ, multiple-point measurements were taken in five different areas on both sides of the scar to determine the maximum and minimum values of scar echo depth and to calculate the average value of the five measurement points.The unit of measurement is millimeters.

    Measured: Baseline,1month,2month,3month,4month,5month,8month,11month,17month

  2. The width of scar echoes

    Using the high-frequency skin ultrasound MD-300SⅡ, multiple-point measurements were taken in five different areas on both sides of the scar to determine the maximum and minimum values of scar echo width and to calculate the average value of the five measurement points.The unit of measurement is millimeters.

    Measured: Baseline,1month,2month,3month,4month,5month,8month,11month,17month

  3. Intensity of scar echoes

    Using image processing software (Adobe Photoshop) to process the ultrasound images, the magic wand tool was used to select three areas of the same size on the scar. The average grayscale value of each area was read using the histogram function, and the average value of the five measurement points was calculated. The grayscale value is proportional to the echo intensity.

    Measured: Baseline,1month,2month,3month,4month,5month,8month,11month,17month

  4. Modified vancouver scar scale score

    The Modified Vancouver Scar Scale has a maximum score of 18 and a minimum score of 0, with higher scores indicating worse outcomes.

    Measured: Baseline,1month,2month,3month,4month,5month,8month,11month,17month

Secondary outcomes (8)

  1. Scar color

    Using the multispectral microscopic imaging device (Multi view®) to perform multiple-point measurements in three different areas on both sides of the scar, calculate the grayscale and red concentration within a specific region, and separately calculate the average values of the three measurement points. The greater the average grayscale, the lighter the skin color, and vice versa. The higher the red concentration, the more severe the skin inflammation, and vice versa.

    Measured: Baseline,1month,2month,3month,4month,5month,8month,11month,17month

  2. Scar area

    Using the multispectral microscopic imaging device (Multi view®), identify the set of pixels with abrupt changes in brightness within the image, and employ edge detection algorithms to calculate the area of scars on both sides.

    Measured: Baseline,1month,2month,3month,4month,5month,8month,11month,17month

  3. Patient and Observer Scar Assessment Scale score

    The Patient and Observer Scar Assessment Scale consists of the Patient Scar Assessment Scale and the Observer Scar Assessment Scale. Both have a maximum score of 60 and a minimum score of 6, with higher scores indicating worse outcomes.

    Measured: Baseline,1month,2month,3month,4month,5month,8month,11month,17month

  4. Manchester Scar Scale score

    The Manchester Scar Scale has a maximum score of 28 and a minimum score of 5, with higher scores indicating worse outcomes.

    Measured: Baseline,1month,2month,3month,4month,5month,8month,11month,17month

  5. Medical Outcomes Study Health Survey Short Form-36 Item score

    Medical Outcomes Study Health Survey Short Form-36 Item (SF-36) consists of nine dimensions and 36 items, measuring eight aspects of health: Physical Functioning (PF), Role Limitations due to Physical Health (RP), Bodily Pain (BP), General Health Perceptions (GH), Vitality (VT), Social Functioning (SF), Role Limitations due to Emotional Problems (RE), and Mental Health (MH). Additionally, there is a self-assessment of health transition (HT) compared to health status one year ago, which is not included in the subscale or total scale scoring and reflects longitudinal dynamic changes. The scoring method involves calculating the sum of weighted item scores within each of the eight subscales to obtain the raw subscale scores, which are then transformed into standard scores ranging from 0 to 100. Higher scale scores indicate better quality of life.

    Measured: Baseline,1month,2month,3month,4month,5month,8month,11month,17month

  6. Standardized assessment by doctor and patient

    Two dermatologists on-site, two dermatologists via photographs, and the patient themselves answered standardized assessment questions, which included: Is there a difference between the left and right side scars? If "yes," which side is superior? The four dermatologists determined the final result using the following algorithm: If any of the four assessments indicated "no difference," or if the assessments of which half of the scar was superior did not match, the final result was determined to be "no difference."

    Measured: Baseline,1month,2month,3month,4month,5month,8month,11month,17month

  7. Incidence of adverse events

    Record and tally the frequency and severity of adverse events occurring during and after scar treatment.Incidence of adverse events = Number of cases with adverse events / Number of cases in the safety dataset × 100%.

    Measured: Baseline,1month,2month,3month,4month,5month,8month,11month,17month

  8. Histological evaluation

    A 3 mm punch skin biopsy was taken from the center of the scar on both the study side and the control side. The biopsies underwent dewaxing, clearing, hematoxylin and eosin (HE) staining, Masson's trichrome staining, elastic fiber staining, and immunohistochemistry for matrix metalloproteinase (MMP9). The ImageJ software was used to calculate the average scar thickness in the HE-stained sections, the average area percentage of collagen fibers in the Masson's trichrome-stained sections, the average area percentage of elastic fibers in the elastic fiber-stained sections, and the average percentage of MMP9-positive cells on both sides.

    Measured: 17month

Timeline

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

  1. First posted25 Jun 2025
  2. Study start1 Sep 2024
  3. Primary completion1 Mar 2026 (estimated)
  4. Study completion1 Mar 2026 (estimated)

Resources

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
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07037264
Sponsor's protocol ID
S2024-594-01
Status last verified
Jun 2025
First submitted
7 Feb 2025
Last updated
25 Jun 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Non-ablative fractional laser treatment in people with Scars After Surgical Intervention, run by Chinese Medical Association at 1 site in China.

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 16 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: enrolling by invitation, as of the sponsor's last update on 25 Jun 2025. 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 China. 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?

This study is still under way. Results are not available in the source record yet.

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?

The depth of scar echoes (time frame: Baseline,1month,2month,3month,4month,5month,8month,11month,17month). The study lists 4 primary outcomes in all. 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 NCT07037264.

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 25 Jun 2025.

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