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

Steroid Acne Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04719559
• Other study ID #: 201800241A3
• Status: Completed
• Phase: N/A
• Start date: March 20, 2018
• Est. completion date: April 2, 2019

Study information

• Verified date: January 2021
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Thyroidectomy results in unsightly scarring at the anterior neck of the patient. A clinical study was conducted to assess the effectiveness of five courses, applied every 4 weeks, of laser-assisted drug delivery (LADD) combining a fractional ablative carbon dioxide laser and topical 0.05% clobetasol propionate to the treatment of post-thyroidectomy hypertrophic scars in patients. Assessments of the scars by the patient themselves according to the patient and observer scar assessment scale.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: April 2, 2019
• Est. primary completion date: August 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 100 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Steroid Acne
• Thyroid; Wound

Intervention

Device:
• Laser-assisted drug delivery
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.

Locations

Country	Name	City	State
Taiwan	Kaohsiung Chang Gung Memorial Hospital	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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