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

NCT04288700 | Unknown Phase 4

• 1 other identifier: 257
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Infantile Hemangioma

Outcome Measures

Primary Outcomes (3)

• Assessment of serum levels of Vascular endothelial growth factor

  6 months

• Assessment of serum levels of CD 133

  6 months

• Assessment of the size of the lesion.

  6 months

Study Arms (4)

Group A

ACTIVE COMPARATOR

Drug: oral propranolol

Group B

ACTIVE COMPARATOR

Drug: Oral Captopril

Group C

ACTIVE COMPARATOR

Drug: intralesional propranolol injection

Group D

ACTIVE COMPARATOR

Drug: topical Timolol maleate 0.5% eye drops

Interventions

oral propranolol DRUG

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.

Group A

Oral Captopril DRUG

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 .

Group B

intralesional propranolol injection DRUG

intralesional propranolol injection 1 mg/mL

Group C

topical Timolol maleate 0.5% eye drops DRUG

To be Applied on the surface of the lesions three times daily

Group D

Eligibility Criteria

• Age: 2 Months - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Vascular malformation clinic of Pediatric Surgery department of Ain Shams University.

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Hemangioma, Capillary

Interventions

Propranolol; Captopril; Timolol; Ophthalmic Solutions

Condition Hierarchy (Ancestors)

Hemangioma; Neoplasms, Vascular Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Proline; Imino Acids; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Thiadiazoles; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morpholines; Oxazines; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Study Officials

• Rana Atta, BSc

  Future University in Egypt

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Atta

CONTACT

01007276664; rana.mohamed.108@outlook.com

Ayman El-Baghdadi, MD

CONTACT

01001223773; aymanalbaghdady@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching Assistant, Pharmacy Practice and Clinical Pharmacy Department

Study Record Dates

• First Submitted: February 26, 2020
• First Posted: February 28, 2020
• Study Start: October 1, 2019
• Primary Completion: December 1, 2020
• Study Completion: October 1, 2021
• Last Updated: February 28, 2020

Record last verified: 2020-02

Locations

EG (1)