- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06510829
Comparison Between Diode Laser and Bleomycin in Treatment of Hemangioma
July 15, 2024 updated by: Kerolos Fayez, Assiut University
Comparative Study Between Effect of Bleomycin Intralesional Injection And Application of Diode Laser on Infantile Hemangioma.
Assessment of the Effectiveness of Bleomycin Intralesional Injection and Diode Laser on Management of Infantile Hemangioma., with regard to :
- Clinically based on Change in the Size and Color of Hemangioma.
- Ultrasonography considering Vascularity ,Echogenicity , Height , and Morphology .
- Comparison of Complications associated with Bleomycin and Diode Laser.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
30
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample
Study Population
Comparative Study Between Effect of Bleomycin Intralesional Injection And Application of Diode Laser on Infantile Hemangioma .
Description
Inclusion Criteria:
- Age between 3 Months and 1 Year old.
- Non Complicated Infantile Hemangioma
Exclusion Criteria:
- Younger than 3 Months or older than 1 Year.
- Complicated Infantile Hemangioma
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Group A
Group will be treated with intralesional bleomycin injection
|
|
|
Group b
Group will be treated with application of diode laser
|
Application of laser waves on the lesion
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Effect of diode laser on hemangioma
Time Frame: 3 years
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
September 1, 2024
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
October 1, 2026
Study Registration Dates
First Submitted
July 15, 2024
First Submitted That Met QC Criteria
July 15, 2024
First Posted (Actual)
July 19, 2024
Study Record Updates
Last Update Posted (Actual)
July 19, 2024
Last Update Submitted That Met QC Criteria
July 15, 2024
Last Verified
July 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Diode laser hemangioma
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.