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NCT Number: NCT04719559

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

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.

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Key information

Conditions

Thyroid; Wound Endocrine System Diseases Steroid Acne Thyroid Diseases Wounds and Injuries

Age range

20 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 83301, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Self-assessment by patients before treatment

    Time frame: before first 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.

  2. Self-assessment by patients after treatment

    Time frame: 1 year after the first 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.

  3. Doctor evaluations using the POSAS scoring range of 1-10

    Time frame: 1 year after the first treatment

    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.

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Jan 22, 2021
Registry last updated
Jan 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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