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

Not Applicable

Completed

• Conditions: Steroid Acne; Thyroid; Wound
• Interventions: Device: Laser-assisted drug delivery

• Registration Number: NCT04719559
• Lead Sponsor: Chang Gung Memorial Hospital

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.

Detailed 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.

Study Timeline

• Study Start: 2018-03-20
• Primary Completion: 2018-08-10
• Study Completion: 2019-04-02
• Status Verified: 2021-01
• Study First Submitted: 2021-01-14
• Study First Submitted QC: 2021-01-19
• Last Update Submitted: 2021-01-19
• Study First Posted: 2021-01-22
• Last Update Posted: 2021-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Post-Thyroidectomy Hypertrophic Scar	Laser-assisted drug delivery	Patients had all presented a persistent hypertrophic scar at the neck region for more than 1 year after their thyroidectomy.

Primary Outcome Measures

Name	Time	Method
Self-assessment by patients after treatment	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.
Self-assessment by patients before treatment	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.
Doctor evaluations using the POSAS scoring range of 1-10	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.

Trial Locations

Locations (1)

Kaohsiung Chang Gung Memorial Hospital; 🇨🇳 Kaohsiung, Taiwan