search
Back to results

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

Primary Purpose

Hemangioma

Status
Completed
Phase
Not Applicable
Locations
Iraq
Study Type
Interventional
Intervention
Diode laser 980-nm
Sponsored by
Noor Taha Ismaeel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemangioma focused on measuring Hemangioma, Randomized within patient, Diode laser, Histogram

Eligibility Criteria

5 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Comfortable.
  2. Superficial lesion.

Exclusion Criteria:

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

Sites / Locations

  • Institute of Laser for Postgraduate Studies

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Iraqi patients with face hemangioma

Arm 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.

Outcomes

Primary Outcome Measures

Area of Hemangioma lesions
Measured area of lesions by tape measure by centimeters
Color of lesion
By inspection color of lesion change from dark red to bright red or disappear
Shape of lesion
Clinical exam by inspection, we look to ugly shape of lesion, may be change for better or disappear

Secondary Outcome Measures

Full Information

First Posted
August 16, 2019
Last Updated
August 20, 2019
Sponsor
Noor Taha Ismaeel
search

1. Study Identification

Unique Protocol Identification Number
NCT04065217
Brief Title
The Effectiveness of Diode Laser 980-nm in Iraqi Face Hemangioma: a Randomized Within Patients Trial
Acronym
NTDL980
Official Title
Diode Laser 980-nm in Hemangioma Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
October 14, 2018 (Actual)
Primary Completion Date
July 30, 2019 (Actual)
Study Completion Date
August 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Noor Taha Ismaeel

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemangioma
Keywords
Hemangioma, Randomized within patient, Diode laser, Histogram

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
uni-center, government clinic, randomized within patient trial
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Iraqi patients with face hemangioma
Arm Type
Other
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Diode laser 980-nm
Intervention Description
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 Outcome Measure Information:
Title
Area of Hemangioma lesions
Description
Measured area of lesions by tape measure by centimeters
Time Frame
4th week
Title
Color of lesion
Description
By inspection color of lesion change from dark red to bright red or disappear
Time Frame
4 weeks
Title
Shape of lesion
Description
Clinical exam by inspection, we look to ugly shape of lesion, may be change for better or disappear
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Comfortable. Superficial lesion. Exclusion Criteria: Advanced case. Deep lesion. Uncomfortable.
Facility Information:
Facility Name
Institute of Laser for Postgraduate Studies
City
Baghdad
ZIP/Postal Code
10001
Country
Iraq

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data availability
IPD Sharing Time Frame
one year
IPD Sharing Access Criteria
Open
IPD Sharing URL
http://doi.org/10.5281/zenodo.3338657

Learn more about this trial

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

We'll reach out to this number within 24 hrs