Bleomycin Adverse ReactionNCT06510829
Comparison Between Diode Laser and Bleomycin in Treatment of Hemangioma
An observational study of Bleomycin Adverse Reaction, run by Assiut University.
Trial 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 . Read more about this study
- Who is it for?
- Ages 3 to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- Bleomycin Adverse Reaction
- What is being tested?
- Diode laser
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2024to Oct 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 12 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Comparative Study Between Effect of Bleomycin Intralesional Injection And Application of Diode Laser on Infantile Hemangioma .
Who may be able to join
- Age between 3 Months and 1 Year old.
- Non Complicated Infantile Hemangioma
Who cannot join
- Younger than 3 Months or older than 1 Year.
- Complicated Infantile Hemangioma
About this study
Official title: 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.
- Conditions
- Bleomycin Adverse Reaction
- Being tested
- Diode laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diode laserDevice
Application of laser waves on the lesion
| Study group | Role | What they receive |
|---|---|---|
| Group A | Group will be treated with intralesional bleomycin injection | |
| Group b | Group will be treated with application of diode laser Receives: Device: Diode laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of diode laser on hemangioma
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2024
- Study start1 Sep 2024 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bleomycin Adverse ReactionStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kerolos Fayez, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06510829
- Sponsor's protocol ID
- Diode laser hemangioma
- Status last verified
- Jul 2024
- First submitted
- 15 Jul 2024
- Last updated
- 19 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Effect of Bleomycin Intralesional Injection And Application of Diode Laser on Infantile Hemangioma.
- ClinicalTrials.gov ID
- NCT06510829
- Acronym / sponsor ID
- Diode laser hemangioma
- Conditions
- Bleomycin Adverse Reaction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 19 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | –Group will be treated with intralesional bleomycin injection |
| Group b | – | Device: Diode laserGroup will be treated with application of diode laser |
Who may qualify
- Ages
- 3 to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Comparative Study Between Effect of Bleomycin Intralesional Injection And Application of Diode Laser on Infantile Hemangioma .
Key inclusion criteria (2 listed)
- Age between 3 Months and 1 Year old.
- Non Complicated Infantile Hemangioma
Key exclusion criteria (2 listed)
- Younger than 3 Months or older than 1 Year.
- Complicated Infantile Hemangioma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diode laserApplication of laser waves on the lesion | Device | Group b |
Primary outcome
Effect of diode laser on hemangioma
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Bleomycin Adverse Reaction, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of diode laser on hemangioma (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2024.