An interventional study of Non-ablative fractional laser treatment in Scars After Surgical Intervention, sponsored by Chinese Medical Association. Enrolling by invitation at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-06-25.
Sponsored by Chinese Medical Association · Not applicable, Interventional, and Treatment
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.
611 studies on the registry are indexed under Cicatrix; 114 are open to participants now.
This study's planned enrollment of 120 is above the median of 40 across 512 interventional studies indexed under Cicatrix.
Browse Cicatrix studies →Chinese Medical Association is the lead sponsor of 40 studies on the registry; 9 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Non-ablative fractional laser treatment
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.
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.
Time frame: Baseline,1month,2month,3month,4month,5month,8month,11month,17month
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.
Time frame: Baseline,1month,2month,3month,4month,5month,8month,11month,17month
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.
Time frame: Baseline,1month,2month,3month,4month,5month,8month,11month,17month
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.
Time frame: Baseline,1month,2month,3month,4month,5month,8month,11month,17month
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.
Time frame: Baseline,1month,2month,3month,4month,5month,8month,11month,17month
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.
Time frame: Baseline,1month,2month,3month,4month,5month,8month,11month,17month
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.
Time frame: Baseline,1month,2month,3month,4month,5month,8month,11month,17month
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.
Time frame: Baseline,1month,2month,3month,4month,5month,8month,11month,17month
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.
Time frame: Baseline,1month,2month,3month,4month,5month,8month,11month,17month
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."
Time frame: Baseline,1month,2month,3month,4month,5month,8month,11month,17month
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%.
Time frame: Baseline,1month,2month,3month,4month,5month,8month,11month,17month
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.
Time frame: 17month
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Chinese Medical Association