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

Diode Laser 980-nm in Hemangioma Treatment

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.

Study Overview

• Status: Completed
• Conditions: Hemangioma
• Intervention / Treatment: Procedure: Diode laser 980-nm

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iraq
  • Baghdad, Iraq, 10001
    • Institute of Laser for Postgraduate Studies

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 60 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Comfortable.
2. Superficial lesion.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Iraqi patients with face hemangioma; 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.

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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Noor Taha Ismaeel

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2018
• Primary Completion (Actual): July 30, 2019
• Study Completion (Actual): August 15, 2019

Study Registration Dates

• First Submitted: August 16, 2019
• First Submitted That Met QC Criteria: August 20, 2019
• First Posted (Actual): August 22, 2019

Study Record Updates

• Last Update Posted (Actual): August 22, 2019
• Last Update Submitted That Met QC Criteria: August 20, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Diode laser; Hemangioma; Randomized within patient; Histogram
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Vascular Tissue; Hemangioma
• Other Study ID Numbers: 1477

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Data availability
• IPD Sharing Time Frame: one year
• IPD Sharing Access Criteria: Open
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No