NCT06510829

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
5mo left

Started Sep 2024

Typical duration for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress81%
Sep 2024Oct 2026

First Submitted

Initial submission to the registry

July 15, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 19, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

July 19, 2024

Status Verified

July 1, 2024

Enrollment Period

2 years

First QC Date

July 15, 2024

Last Update Submit

July 15, 2024

Conditions

Bleomycin Adverse Reaction

Outcome Measures

Primary Outcomes (1)

  • Effect of diode laser on hemangioma

    3 years

Study Arms (2)

Group A

Group will be treated with intralesional bleomycin injection

Group b

Group will be treated with application of diode laser

Device: Diode laser

Interventions

Diode laserDEVICE

Application of laser waves on the lesion

Group b

Eligibility Criteria

Age3 Months - 12 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Comparative Study Between Effect of Bleomycin Intralesional Injection And Application of Diode Laser on Infantile Hemangioma .

You may qualify if:

  • Age between 3 Months and 1 Year old.
  • Non Complicated Infantile Hemangioma

You may not qualify if:

  • Younger than 3 Months or older than 1 Year.
  • Complicated Infantile Hemangioma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Lasers, Semiconductor

Intervention Hierarchy (Ancestors)

LasersOptical DevicesEquipment and SuppliesRadiation Equipment and Supplies

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Kerolos Fayez Youakeem

Study Record Dates

First Submitted

July 15, 2024

First Posted

July 19, 2024

Study Start

September 1, 2024

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

July 19, 2024

Record last verified: 2024-07