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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04288700
Other study ID # 257
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date October 1, 2019
Est. completion date October 1, 2021

Study information

Verified date February 2020
Source Ain Shams University
Contact Atta
Phone 01007276664
Email rana.mohamed.108@outlook.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Is to compare and evaluate the efficacy of oral captopril with oral propranolol, intralesional propranolol injection, and topical Timolol in the treatment of infantile hemangioma and their effect on vascular endothelial growth factor and CD 133.


Description:

Infantile hemangiomas are the most common benign tumor of infancy, affecting up to 10% of the pediatric population with a higher incidence in female (3:1), preterm infants, and Caucasian population. The molecular mechanisms underlying pathogenesis remain incompletely understood, but the clinical course follows a stereotyped pattern: a phase of early vascular proliferation over the first year of life followed by a gradual phase (1 to7 years in duration) of spontaneous involution and replacement of vascular channels by fibro-fatty tissue. Despite their benign nature,in certain cases IHs can cause severe morbidities and therefore sometimes require medical intervention.

Vascular endothelial growth factor A is the predominant growth factor associated with endothelial proliferation, migration, and survival. Vascular endothelial growth factor, being a potent inducer of vascular permeability, is known to cause edema and lead to formation of hemangiomas in high concentrations along with CD133 is a transmembrane glycoprotein which represents a cell surface marker for hemangioma-derived stem cells (HemSCs). CD133-positive HemSCs can still be diļ¬€erentiated into hemangiomas, suggesting that CD133-positive HemSCs have continuous ability to form hemangiomas. Targeted elimination of CD133-positive HemSCs could fundamentally inhibit the proliferation of hemangioma.

Aim of the study is to compare and evaluate the efficacy of oral captopril with oral propranolol, intralesional propranolol injection, and topical Timolol in the treatment of infantile hemangioma and their effect on vascular endothelial growth factor and CD 133.

Methodology : Open label Randomized Controlled trail will be carried out at Vascular malformation clinic of Pediatric Surgery department of Ain Shams University ,Patients of the study will be randomly allocated equally into 4 groups (A, B, C, D), 25 patients each.

- Group A: Subjected to oral propranolol therapy at a dose of 2 mg/kg/d in three divided doses.

- Group B: Oral Captopril will be administered as a test dose of 0.1 mg kg orally with pulse rate and blood pressure monitored at 0.5, 1 and 2 h and at each follow up. If the test dose is tolerated, captopril administration will start at 0.15 mg/ kg) per dose 8-hourly. Pulse rate and blood pressure will be monitored 4-hourly and doses will be withheld if hypotension is documented. After 24 h, the dose will be increased to 0.3 mg/ kg) per dose 8-hourly.

- Group C: Subjected to intralesional propranolol injection 1 mg/mL. The volume of injected drug depends on the size of the lesion (0.2 mL will be injected per cm of lesion diameter), with a maximum volume of 1 mL for a lesion of 5 cm diameter

- Group D: Subjected to topical Timolol maleate 0.5% eye drops on the surface of the lesions three times daily and gentamycin ointment will be applied around the lesions to prevent the timolol from leaking.

Following up: Venous blood samples will be withdrawn from all study participants at study entry and after 6 months of treatment for assessment of serum levels of VEGF and CD 133 by ELISA technique along with the size of the lesion.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date October 1, 2021
Est. primary completion date December 1, 2020
Accepts healthy volunteers No
Gender All
Age group 2 Months to 12 Years
Eligibility Inclusion Criteria:

- Pediatric patients younger than 12 years and older than 2 months of age with infantile hemangioma

Exclusion Criteria:

- Patient with ulcerated or infected hemangioma.

- Patient younger than 2 months and older than 12 years of age.

- Patients with multiple hemangiomas.

- Any Patient with cardiovascular problems, bronchial asthma, diabetes mellitus, bilateral renal stenosis, Electrolyte disturbance, or renal impairment was excluded.

- Patients with abnormal electrocardiogram, or echocardiogram should be excluded.

- Patients who have had previous treatment for hemangioma.

Study Design


Intervention

Drug:
oral propranolol
oral propranolol therapy at a dose of 1 mg/kg/d (Inderal 20 mg/5 mL) in three divided doses. If the child will tolerate the treatment with no side effects, therapy will continue in an outpatient clinic. Blood glucose level will be also measured in a periodic manner during therapy. The dose will be increased gradually to 2 mg/kg/d in three divided doses if there will be no adverse effects from the initial therapy.
Oral Captopril
A test dose of 0.1 mg kg) will be administered orally with pulse rate and blood pressure monitored at 0.5, 1 and 2 h and at each follow up. If the test dose is tolerated, captopril administration will start at 0.15 mg kg) per dose 8-hourly. Pulse rate and blood pressure will be monitored 4-hourly and doses will be withheld if hypotension is documented. After 24 h, the dose will be increased to 0.3 mg kg) per dose 8-hourly .
intralesional propranolol injection
intralesional propranolol injection 1 mg/mL
topical Timolol maleate 0.5% eye drops
To be Applied on the surface of the lesions three times daily

Locations

Country Name City State
Egypt Vascular malformation clinic of Pediatric Surgery department of Ain Shams University. Cairo

Sponsors (1)

Lead Sponsor Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Assessment of serum levels of Vascular endothelial growth factor 6 months
Primary Assessment of serum levels of CD 133 6 months
Primary Assessment of the size of the lesion. 6 months
See also
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Completed NCT01431326 - Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care
Completed NCT01010308 - Nadolol for Proliferating Infantile Hemangiomas Phase 2
Completed NCT02913612 - Efficacy, Safety and Pharmacokinetics of Topical Timolol in Infants With Infantile Hemangioma (IH) Phase 2
Completed NCT01673971 - Optical Tomographic Imaging of Infantile Hemangiomas
Recruiting NCT03237637 - Comparative Study to Evaluate the Effectiveness of Atenolol and Propranolol in the Treatment of Infantile Hemangiomas Phase 3
Recruiting NCT05479123 - Assessing the Impact of Dosage Frequency of Propranolol on Sleep Patterns in Patients With Infantile Hemangiomas Phase 4
Terminated NCT01434849 - Timolol for the Prevention of Proliferation of Infantile Hemangioma (TiPPIH Trial) Phase 1
Completed NCT04105517 - Hemangiol, Post Marketing Surveillance Study
Completed NCT01512173 - Study in Infants With Infantile Hemangioma to Compare Propranolol Gel to Placebo Phase 2
Completed NCT01056341 - Study to Demonstrate the Efficacy and Safety of Propranolol Oral Solution in Infants With Proliferating Infantile Hemangiomas Requiring Systemic Therapy Phase 2/Phase 3
Not yet recruiting NCT04684667 - ''Efficacy of Propranolol in the Treatment of Infantile Hemangioma" Phase 2
Recruiting NCT03842631 - Optimizing Timolol Maleate Treatment of Infantile Hemangioma by Doppler Ultrasound Examination
Recruiting NCT03173352 - A Prospective Study on the Incidence and Related Risk Factors of Infantile Hemangioma in China N/A