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Evaluation of the Efficacy of Captopril Versus Propranolol and Timolol as a Treatment of Infantile Capillary Hemangioma

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ClinicalTrials.gov Identifier: NCT04288700
Recruitment Status : Recruiting
First Posted : February 28, 2020
Last Update Posted : February 28, 2020
Sponsor:
Information provided by (Responsible Party):
Rana Mohamed El-Sayed Ibrahim Atta, Ain Shams University

Brief 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.

Condition or disease Intervention/treatment Phase
Infantile Hemangioma Drug: oral propranolol Drug: Oral Captopril Drug: intralesional propranolol injection Drug: topical Timolol maleate 0.5% eye drops Phase 4

Detailed 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 differentiated 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Efficacy of Captopril Versus Propranolol and Timolol as a Treatment of Infantile Capillary Hemangioma
Actual Study Start Date : October 1, 2019
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : October 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birthmarks

Arm Intervention/treatment
Active Comparator: Group A 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.

Active Comparator: Group B Drug: 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 .

Active Comparator: Group C Drug: intralesional propranolol injection
intralesional propranolol injection 1 mg/mL

Active Comparator: Group D Drug: topical Timolol maleate 0.5% eye drops
To be Applied on the surface of the lesions three times daily




Primary Outcome Measures :
  1. Assessment of serum levels of Vascular endothelial growth factor [ Time Frame: 6 months ]
  2. Assessment of serum levels of CD 133 [ Time Frame: 6 months ]
  3. Assessment of the size of the lesion. [ Time Frame: 6 months ]


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Ages Eligible for Study:   2 Months to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04288700


Contacts
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Contact: Atta 01007276664 rana.mohamed.108@outlook.com
Contact: Ayman El-Baghdadi, MD 01001223773 aymanalbaghdady@yahoo.com

Locations
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Egypt
Vascular malformation clinic of Pediatric Surgery department of Ain Shams University. Recruiting
Cairo, Egypt
Contact: Ayman El-Boghdadi, MD    01001223773    aymanalboghdady@yahoo.com   
Sponsors and Collaborators
Ain Shams University
Investigators
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Principal Investigator: Rana Atta, BSc Future University in Egypt
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Responsible Party: Rana Mohamed El-Sayed Ibrahim Atta, Teaching Assistant, Pharmacy Practice and Clinical Pharmacy Department, Ain Shams University
ClinicalTrials.gov Identifier: NCT04288700    
Other Study ID Numbers: 257
First Posted: February 28, 2020    Key Record Dates
Last Update Posted: February 28, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hemangioma
Hemangioma, Capillary
Port-Wine Stain
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Neoplasms
Skin Abnormalities
Congenital Abnormalities
Skin Diseases
Timolol
Propranolol
Captopril
Ophthalmic Solutions
Pharmaceutical Solutions
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Enzyme Inhibitors
Vasodilator Agents
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors