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

NCT ID: NCT04719559

Last Updated: 2021-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-20

Study Completion Date

2019-04-02

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Thyroid; Wound Steroid Acne

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Post-Thyroidectomy Hypertrophic Scar

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

Group Type OTHER

Laser-assisted drug delivery

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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201800241A3

Identifier Type: -

Identifier Source: org_study_id

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