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Completed

NCT Number: NCT04065217

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

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.

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Key information

Age range

5 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Laser for Postgraduate Studies

Baghdad, 10001, Iraq

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Comfortable.
  • Superficial lesion.

Exclusion criteria

  • Advanced case.
  • Deep lesion.
  • Uncomfortable.

Treatment and study plan

Diode laser 980-nm

Procedure

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.

Primary outcomes

  1. Area of Hemangioma lesions

    Time frame: 4th week

    Measured area of lesions by tape measure by centimeters

  2. Color of lesion

    Time frame: 4 weeks

    By inspection color of lesion change from dark red to bright red or disappear

  3. Shape of lesion

    Time frame: 4 weeks

    Clinical exam by inspection, we look to ugly shape of lesion, may be change for better or disappear

Sponsors and collaborators

Lead sponsor

Noor Taha Ismaeel

Other

Registry information

Official study title

Diode Laser 980-nm in Hemangioma Treatment

Acronym: NTDL980

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 22, 2019
Registry last updated
Aug 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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