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Clinical Trials/NCT04719559
NCT04719559
Completed
Not Applicable

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

Chang Gung Memorial Hospital1 site in 1 country10 target enrollmentMarch 20, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Thyroid; Wound
Sponsor
Chang Gung Memorial Hospital
Enrollment
10
Locations
1
Primary Endpoint
Self-assessment by patients after treatment
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 20, 2018
End Date
April 2, 2019
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Chang Gung Memorial Hospital
Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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.

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.

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.

Study Sites (1)

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