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

NCT04065217 | Completed DMC

• 1 other identifier: 1477
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemangioma

Keywords

Hemangioma; Randomized within patient; Diode laser; Histogram

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

Iraqi patients with face hemangioma

OTHER

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

Interventions

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.

Iraqi patients with face hemangioma

Eligibility Criteria

• Age: 5 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Comfortable.
• Superficial lesion.

You may not qualify if:

• Advanced case.
• Deep lesion.
• Uncomfortable.

Sponsors & Collaborators

• Noor Taha Ismaeel: lead

Study Sites (1)

Institute of Laser for Postgraduate Studies

Baghdad, 10001, Iraq

Location

MeSH Terms

Conditions

Hemangioma

Interventions

Lasers, Semiconductor

Condition Hierarchy (Ancestors)

Neoplasms, Vascular Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Lecturer

Model Details: uni-center, government clinic, randomized within patient trial

Study Record Dates

• First Submitted: August 16, 2019
• First Posted: August 22, 2019
• Study Start: October 14, 2018
• Primary Completion: July 30, 2019
• Study Completion: August 15, 2019
• Last Updated: August 22, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: one year
• Access Criteria: Open

Locations

IR (1)