The Effectiveness of Diode Laser 980-nm in Iraqi Face Hemangioma: a Randomized Within Patients Trial

Not Applicable

Completed

• Conditions: Hemangioma

• Registration Number: NCT04065217
• Lead Sponsor: Noor Taha Ismaeel

Brief Summary

In an academic, government clinic, uni-center, randomized within patients trial study of the effects of 980-nm diode laser treatment included 15 cases of facial hemangiomas in patients with a history of discomfort due to lesions that were not suitable for removal using traditional methods. The study was carried out at the University of Baghdad/Institute of Laser for Postgraduate Studies/Laser Medicine Research Clinics from 15 October 2018 to 15 April 2019. Primary end-point is improvement of conditions at 6 months. Secondary end-points are quality of life, disappear lesions and safety administration of diode laser. Each patient received 12 sessions at two-week intervals. Lesions were photographed before and after laser treatment and digital image histograms were generated as a graphical representation of the tonal distribution.

Following treatment, the lesions were less elevated, smoother in texture, and the color changed from dark red to light pink.

There is a need to improve the treatment of face hemangiomas. Results from this randomized within patient trial will serve as preliminary evidence of the future role of diode laser in hemangioma treatment and a basis for design and power estimations of future studies. Based on the skin texture, color and elevation of the hemangioma as well as patient satisfaction, this type of laser is a safe and effective modality for the treatment of facial hemangioma in Iraqi patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-14
• Primary Completion: 2019-07-30
• Status Verified: 2019-08
• Study Completion: 2019-08-15
• Study First Submitted: 2019-08-16
• Study First Submitted QC: 2019-08-20
• Last Update Submitted: 2019-08-20
• Study First Posted: 2019-08-22
• Last Update Posted: 2019-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

1. Comfortable.
2. Superficial lesion.

Exclusion Criteria

1. Advanced case.
2. Deep lesion.
3. Uncomfortable.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Area of Hemangioma lesions	4th week	Measured area of lesions by tape measure by centimeters
Color of lesion	4 weeks	By inspection color of lesion change from dark red to bright red or disappear
Shape of lesion	4 weeks	Clinical exam by inspection, we look to ugly shape of lesion, may be change for better or disappear

Trial Locations

Locations (1)

Institute of Laser for Postgraduate Studies; 🇮🇶 Baghdad, Iraq