Fractional Laser and Steroid Ointment to Improve the Old Scar After Thyroidectomy

NCT04719559 | Completed

• 1 other identifier: 201800241A3
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical study was conducted to assess the effects of LADD combined with a fractional ablative carbon dioxide laser and a topical steroid for the treatment of post-thyroidectomy hypertrophic scars.

Conditions

Thyroid; Wound; Steroid Acne

Outcome Measures

Primary Outcomes (3)

• Self-assessment by patients before treatment

  For each patient's self-assessment before the first treatment, we adopted the patient and observer scar assessment scale (POSAS)18, with a range of 1-10 for representing the severity of the itchiness, pain, color, softness, thickness, irregularity, and distorted appearance of the scar.

  before first treatment

• Self-assessment by patients after treatment

  For each patient's self-assessment1 year after the first treatment, we adopted the patient and observer scar assessment scale (POSAS)18, with a range of 1-10 for representing the severity of the itchiness, pain, color, softness, thickness, irregularity, and distorted appearance of the scar.

  1 year after the first treatment

• Doctor evaluations using the POSAS scoring range of 1-10

  Four doctors participated as observers of the clinical outcomes. One of the doctors carried out all treatments and evaluated seven parameters, namely, vascularity, pigmentation, thickness, relief, pliability, surface area, and overall opinion based on the POSAS using a scoring range of 1-10, from normal to worst conditions 1 year after the first treatment. The remaining three doctors acted as observers to evaluate the general appearances of the scars based on photographs captured by the same photographer with the same camera 1 year after the first treatment. They then rated the scar on a score of 1-10.

  1 year after the first treatment

Study Arms (1)

Post-Thyroidectomy Hypertrophic Scar

OTHER

Patients had all presented a persistent hypertrophic scar at the neck region for more than 1 year after their thyroidectomy.

Device: Laser-assisted drug delivery

Interventions

Laser-assisted drug delivery DEVICE

All patients received treatment using the same protocol with the same fractional ablative carbon dioxide laser (eCO2 PlusTM, manufactured by Lutronic, South Korea). Each patient was applied with Lidopin 5% cream (Panion \& BF Biotech Inc.), which remained on the scar for 30 min for pain relief before each laser course. Later, the Lidopin 5% cream was gently removed using a normal saline-rinsed gauze, and the scar was treated with a fractional ablative carbon dioxide laser with two passes under a 10,600 nm wavelength, 120 mm spot size, pulse energy of 50 mJ, 30 W of power, and a density of 200. A topical steroid cream (clobetasol propionate, 0.05%) was evenly applied on the scar gently back and forth using a cotton swab immediately after the laser treatment. The patients underwent five full courses by the same doctor according to the same protocol, with each course given 4 weeks apart.

Post-Thyroidectomy Hypertrophic Scar

Eligibility Criteria

• Age: 20 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients had presented a persistent hypertrophic scar at the neck region for more than 1 year after their thyroidectomy.

You may not qualify if:

• Systemic chronic disease or a history of autoimmune disease or human immunodeficiency virus infections.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 83301, Taiwan

Location

MeSH Terms

Conditions

Thyroid Diseases; Wounds and Injuries

Condition Hierarchy (Ancestors)

Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2021
• First Posted: January 22, 2021
• Study Start: March 20, 2018
• Primary Completion: August 10, 2018
• Study Completion: April 2, 2019
• Last Updated: January 22, 2021

Record last verified: 2021-01

Locations

TW (1)