Skip to content

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

Diode Laser 980-nm in Hemangioma Treatment

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04065217
Acronym
NTDL980
Enrollment
15
Registered
2019-08-22
Start date
2018-10-14
Completion date
2019-08-15
Last updated
2019-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemangioma

Keywords

Hemangioma, Randomized within patient, Diode laser, Histogram

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.

Interventions

PROCEDUREDiode 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.

Sponsors

Noor Taha Ismaeel
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

uni-center, government clinic, randomized within patient trial

Eligibility

Sex/Gender
ALL
Age
5 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

1. Comfortable. 2. Superficial lesion.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Area of Hemangioma lesions4th weekMeasured area of lesions by tape measure by centimeters
Color of lesion4 weeksBy inspection color of lesion change from dark red to bright red or disappear
Shape of lesion4 weeksClinical exam by inspection, we look to ugly shape of lesion, may be change for better or disappear

Countries

Iraq

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026