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

NCT07037264 | Enrolling By Invitation FDA Device

• 1 other identifier: S2024-594-01
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Scars After Surgical Intervention

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

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

Secondary Outcomes (8)

• Scar color

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

• Scar area

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

• Patient and Observer Scar Assessment Scale score

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

• Manchester Scar Scale score

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

• Medical Outcomes Study Health Survey Short Form-36 Item score

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

Study Arms (1)

Non-ablative fractional laser treatment

EXPERIMENTAL

Device: Non-ablative fractional laser treatment

Interventions

Non-ablative fractional laser treatment DEVICE

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.

Non-ablative fractional laser treatment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Chinese Medical Association: lead

Study Sites (1)

Chinese PLA Genaral Hosptial

Beijing, Beijing Municipality, 100853, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor.

Study Record Dates

• First Submitted: February 7, 2025
• First Posted: June 25, 2025
• Study Start: September 1, 2024
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: June 25, 2025

Record last verified: 2025-06

Locations

CN (1)