The Effectiveness of Diode Laser 980-nm in Iraqi Face Hemangioma: a Randomized Within Patients Trial (NTDL980)

Noor Taha Ismaeel

Status: Completed

Conditions: Hemangioma

Treatments: Procedure: Diode laser 980-nm

Study type: Interventional

Funder types: Other

Identifiers

NCT04065217

1477

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 5 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Comfortable.
2. Superficial lesion.

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Iraqi patients with face hemangioma

Other group

Description:

Diode laser 980-nm in the diseased group only while we no need the comparator group because we compared between lesion before and after. The administration of laser is scheduled to start treatment. Patients will take laser therapy as a 12 session at two week-interval. In case of intolerance, session number reduction by 10, 8, 6, 4 allowed. Adherence to treatment will be assessed at each interval for undesired side effects or complications. The intervention should continue also after complete session, or during temporary interval withdrawal due to reached maximal cumulative response or side effects from laser therapy.

Treatment:

Procedure: Diode laser 980-nm