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

Hemangioma Clinical Trial

— NTDL980  

Official title:

Diode Laser 980-nm in Hemangioma Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04065217
• Other study ID #: 1477
• Status: Completed
• Phase: N/A
• Start date: October 14, 2018
• Est. completion date: August 15, 2019

Study information

• Verified date: August 2019
• Source: University of Baghdad
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: August 15, 2019
• Est. primary completion date: July 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 60 Years

Eligibility

Inclusion Criteria:

1. Comfortable.

2. Superficial lesion.

Exclusion Criteria:

1. Advanced case.

2. Deep lesion.

3. Uncomfortable.

Related Conditions & MeSH terms

• Hemangioma

Intervention

Procedure:
• Diode laser 980-nm
Before starting the laser session, cosmetics or makeup were removed and the skin was cleaned. The area was anesthetized by the application of as EMLA lotion (lidocaine 2.5% + prilocaine 2.5%) [ONLY MEDICAL; CAT No. R331/72394/P001] 20 minutes before the session. During the procedure, the laser probe was held perpendicular to the lesion and a guide beam was used to direct the application. The patient wore protective eye goggles [CE; DIR 8001100L4]. After the session, cool air was applied to the whole region. Each patient received a maximum of six sessions, delivered at two-week intervals. Patients reported itchiness and erythema during the session.

Locations

Country	Name	City	State
Iraq	Institute of Laser for Postgraduate Studies	Baghdad

Sponsors (1)

Lead Sponsor	Collaborator
Noor Taha Ismaeel

Country where clinical trial is conducted

Iraq, 

Outcome

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