''Efficacy of Propranolol in the Treatment of Infantile Hemangioma"

NCT04684667 | Unknown Phase 2

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

Brief Summary

''Evaluation of the Efficacy of Propranolol in the Treatment of Infantile Hemangioma"

Conditions

Infantile Hemangioma

Keywords

Hemangioma; Propranolol; Beta Blockers

Outcome Measures

Primary Outcomes (1)

• Complete clinical clearance of hemangioma or reduction of hemangioma's volume.

  The efficacy of the treatment will be evaluated by complete clinical clearance of lesion (defined arbitrarily as \>90% reduction in the size of Infantile Hemangioma as assessed by Physician Global Assessment) or after 9 months of treatment (primary end point) whichever is earlier for cutaneous infantile hemangiomas and by volume reduction of hemangiomas as evaluated by the proper imaging modalities ( Ultrasound, CT, or MRI) for non cutaneous hemangiomas.

  within 9 months

Study Arms (1)

Propranolol Therapy

OTHER

This arm will involve patients with infantile hemangiomas who will be admitted at the Assiut University Children Hospital between January 2021 and December 2021.

Drug: Propranolol Therapy for Infantile Hemangioma

Interventions

Propranolol Therapy for Infantile Hemangioma DRUG

If there are no contraindications to propranolol, it will be given at initial dose of 0.5 mg /kg/day in 2-3 divided doses with feeds and the patients will be observed for clinical signs of serious adverse reactions. If the dose is tolerated, it will be maintained for four to seven days, and then it will be increased by 0.5mg/kg/day every four days to the target dose of 2mg/kg/day. The patients will be observed for 2 hours after each dose increase for the clinical signs of severe side effects.

Also known as: Propranolol Treatment for Infantile Hemangioma

Propranolol Therapy

Eligibility Criteria

• Age: 1 Day - 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children diagnosed with problematic infantile hemangiomas:
• A-Large hemangiomas at increased risk of scarring or disfigurement at any site. B-Hemangiomas carrying functional risks near the eyes, nose, natural orifices, limbs, genitalia.
• C-Ulcerated infantile hemangiomas. D-Uncomplicated progressive infantile hemangiomas with unpredictable future course.
• E-Life-threatening hemangiomas.
• Multiple hemangiomas

You may not qualify if:

• Patients older than 1 year of age.
• Patients with heart diseases.
• Patients with history of bronchspasm or wheezing.
• Patients with Hypotension.
• Patients with Hypertension.
• Premature infants with corrected age less than 5 weeks.
• Patients with conditions affecting blood glucose maintenance.
• Patients with liver failure.
• Patients with PHACES syndrome.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University Teaching Hospital

Asyut, 71526, Egypt

Location

Related Publications (20)

• Darrow DH, Greene AK, Mancini AJ, Nopper AJ; SECTION ON DERMATOLOGY, SECTION ON OTOLARYNGOLOGY-HEAD AND NECK SURGERY, and SECTION ON PLASTIC SURGERY. Diagnosis and Management of Infantile Hemangioma. Pediatrics. 2015 Oct;136(4):e1060-104. doi: 10.1542/peds.2015-2485.

  PMID: 26416931 BACKGROUND

• Darrow DH, Greene AK, Mancini AJ, Nopper AJ; SECTION ON DERMATOLOGY, SECTION ON OTOLARYNGOLOGY-HEAD & NECK SURGERY, AND SECTION ON PLASTIC SURGERY. Diagnosis and Management of Infantile Hemangioma: Executive Summary. Pediatrics. 2015 Oct;136(4):786-91. doi: 10.1542/peds.2015-2482. No abstract available.

  PMID: 26416928 BACKGROUND

• Leaute-Labreze C, Harper JI, Hoeger PH. Infantile haemangioma. Lancet. 2017 Jul 1;390(10089):85-94. doi: 10.1016/S0140-6736(16)00645-0. Epub 2017 Jan 13.

  PMID: 28089471 BACKGROUND

• HOLMDAHL K. Cutaneous hemangiomas in premature and mature infants. Acta Paediatr (Stockh). 1955 Jul;44(4):370-9. doi: 10.1111/j.1651-2227.1955.tb04151.x. No abstract available.

  PMID: 13292246 BACKGROUND

• Amir J, Metzker A, Krikler R, Reisner SH. Strawberry hemangioma in preterm infants. Pediatr Dermatol. 1986 Sep;3(4):331-2. doi: 10.1111/j.1525-1470.1986.tb00535.x.

  PMID: 3774653 BACKGROUND

• Hemangioma Investigator Group; Haggstrom AN, Drolet BA, Baselga E, Chamlin SL, Garzon MC, Horii KA, Lucky AW, Mancini AJ, Metry DW, Newell B, Nopper AJ, Frieden IJ. Prospective study of infantile hemangiomas: demographic, prenatal, and perinatal characteristics. J Pediatr. 2007 Mar;150(3):291-4. doi: 10.1016/j.jpeds.2006.12.003.

  PMID: 17307549 BACKGROUND

• Margileth AM, Museles M. Cutaneous hemangiomas in children. Diagnosis and conservative management. JAMA. 1965 Nov 1;194(5):523-6. No abstract available.

  PMID: 5897362 BACKGROUND

• Bennett ML, Fleischer AB Jr, Chamlin SL, Frieden IJ. Oral corticosteroid use is effective for cutaneous hemangiomas: an evidence-based evaluation. Arch Dermatol. 2001 Sep;137(9):1208-13. doi: 10.1001/archderm.137.9.1208.

  PMID: 11559219 BACKGROUND

• Greenberger S, Boscolo E, Adini I, Mulliken JB, Bischoff J. Corticosteroid suppression of VEGF-A in infantile hemangioma-derived stem cells. N Engl J Med. 2010 Mar 18;362(11):1005-13. doi: 10.1056/NEJMoa0903036.

  PMID: 20237346 BACKGROUND

• Crum R, Szabo S, Folkman J. A new class of steroids inhibits angiogenesis in the presence of heparin or a heparin fragment. Science. 1985 Dec 20;230(4732):1375-8. doi: 10.1126/science.2416056.

  PMID: 2416056 BACKGROUND

• Boon LM, MacDonald DM, Mulliken JB. Complications of systemic corticosteroid therapy for problematic hemangioma. Plast Reconstr Surg. 1999 Nov;104(6):1616-23. doi: 10.1097/00006534-199911000-00002.

  PMID: 10541160 BACKGROUND

• Barlow CF, Priebe CJ, Mulliken JB, Barnes PD, Mac Donald D, Folkman J, Ezekowitz RA. Spastic diplegia as a complication of interferon Alfa-2a treatment of hemangiomas of infancy. J Pediatr. 1998 Mar;132(3 Pt 1):527-30. doi: 10.1016/s0022-3476(98)70034-4.

  PMID: 9544915 BACKGROUND

• Deb G, Jenkner A, Donfrancesco A. Spastic diplegia and interferon. J Pediatr. 1999 Mar;134(3):382. doi: 10.1016/s0022-3476(99)70474-9. No abstract available.

  PMID: 10064684 BACKGROUND

• Leaute-Labreze C, Dumas de la Roque E, Hubiche T, Boralevi F, Thambo JB, Taieb A. Propranolol for severe hemangiomas of infancy. N Engl J Med. 2008 Jun 12;358(24):2649-51. doi: 10.1056/NEJMc0708819. No abstract available.

  PMID: 18550886 BACKGROUND

• Sans V, de la Roque ED, Berge J, Grenier N, Boralevi F, Mazereeuw-Hautier J, Lipsker D, Dupuis E, Ezzedine K, Vergnes P, Taieb A, Leaute-Labreze C. Propranolol for severe infantile hemangiomas: follow-up report. Pediatrics. 2009 Sep;124(3):e423-31. doi: 10.1542/peds.2008-3458. Epub 2009 Aug 10.

  PMID: 19706583 BACKGROUND

• Buckmiller LM, Munson PD, Dyamenahalli U, Dai Y, Richter GT. Propranolol for infantile hemangiomas: early experience at a tertiary vascular anomalies center. Laryngoscope. 2010 Apr;120(4):676-81. doi: 10.1002/lary.20807.

  PMID: 20112413 BACKGROUND

• Bagazgoitia L, Torrelo A, Gutierrez JC, Hernandez-Martin A, Luna P, Gutierrez M, Bano A, Tamariz A, Larralde M, Alvarez R, Pardo N, Baselga E. Propranolol for infantile hemangiomas. Pediatr Dermatol. 2011 Mar-Apr;28(2):108-14. doi: 10.1111/j.1525-1470.2011.01345.x. Epub 2011 Mar 8.

  PMID: 21385205 BACKGROUND

• Cushing SL, Boucek RJ, Manning SC, Sidbury R, Perkins JA. Initial experience with a multidisciplinary strategy for initiation of propranolol therapy for infantile hemangiomas. Otolaryngol Head Neck Surg. 2011 Jan;144(1):78-84. doi: 10.1177/0194599810390445.

  PMID: 21493392 BACKGROUND

• Holland KE, Frieden IJ, Frommelt PC, Mancini AJ, Wyatt D, Drolet BA. Hypoglycemia in children taking propranolol for the treatment of infantile hemangioma. Arch Dermatol. 2010 Jul;146(7):775-8. doi: 10.1001/archdermatol.2010.158.

  PMID: 20644039 BACKGROUND

• Harrison DC, Meffin PJ, Winkle RA. Clinical pharmacokinetics of antiarrhythmic drugs. Prog Cardiovasc Dis. 1977 Nov-Dec;20(3):217-42. doi: 10.1016/0033-0620(77)90022-6. No abstract available.

  PMID: 335439 BACKGROUND

MeSH Terms

Conditions

Hemangioma, Capillary; Hemangioma

Condition Hierarchy (Ancestors)

Neoplasms, Vascular Tissue; Neoplasms by Histologic Type; Neoplasms

Central Study Contacts

Essam EA Mowannas, MD

CONTACT

+201285289188; essamezzat81@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This study will involve patients with infantile hemangiomas who will be admitted at the Assiut University Children Hospital between January 2021 and December 2021.

Study Record Dates

• First Submitted: April 29, 2020
• First Posted: December 24, 2020
• Study Start: January 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: December 24, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The data is anticipated to become available on or after August 2022 and it will remain available for 5 years.
• Access Criteria: will be provided later

Locations

EG (1)