Role of Propranolol as Compared to Bleomycin in Management of Hemangioma

NCT05327309 | Completed DMC

• 1 other identifier: 166SZABMU
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

Infantile hemangiomas are widespread vascular tumours having incidence of 10% and most of them involute spontaneously. However, they are known to be located in proximity of vital organs and can have poor cosmetic and functional sequel if left untreated. A wide range of treatment options are available from expectant therapy to radical surgical excision. Propanolol has also been shown to be effective in treating infantile cutaneous hemangiomas. Similarly, anti-metabolite drugs as bleomycin has also shown promising results. Efficacy in terms of reduction in size of both treatments has been scarcely studied especially in Pakistan. OBJECTIVE: To assess the efficacy of oral propranolol and intraleisonal bleomycin in the treatment of infantile cutaneous hemangioma in terms of size regression

Conditions

Hemangioma; Propranolol

Keywords

Infantile Cutaneous hemangioma; Propranolol treatment; Bleomycin treatment; Efficacy

Outcome Measures

Primary Outcomes (2)

• Size change

  Size change: It is defined as change in size at three or six months compared to baseline size of hemangioma and represented in terms of percentage. Percentage size change = Size of hemangioma at 3 or 6 months x 100 Initial Size Left over Signs after treatment: defined as development of scar, hyperpigmentation or change in texture of skin at the location where hemangioma was previously present. Efficacy: The efficacy of propranolol and bleomycin will be evaluated for change in the size of the lesion, change in the colour of the lesion, epithelialisation in case of ulceration, complications following therapy, and signs of relapse after therapy. The outcome based on change in size will be graded as follows: I Complete involution, implying greater than 90percent response. II Response of change in size of 75 to 90percent III Response of change in size of 50 to 75percent. IV Response of change in size of 25 to 50 percent

  02 years

• Size Regression Efficacy Complications:

  Objective To evaluate the efficacy of oral propranolol as compared to intralesional Bleomycin in management of cutaneous infantile hemangioma in terms of size change. Operational Definition Infantile Hemangiomas: These are vascular neoplasms which are lesions characterized by abnormal proliferation of endothelial cells and aberrant blood vessel architecture which proliferate after birth and are diagnosed clinically as cherry red vascular lesions. Complications: Propranolol: The known complications which could be present in group taking propranolol were hypotension, pulmonary symptoms as wheeze and precipitation of asthma and hypoglycemia. These findings were carefully looked for in the group taking propranolol. Bleomycin: The known complications which could be present in group taking bleomycin were Pulmonary symptoms as shortness of breath, bleeding and ulceration of lesions. These symptoms and signs were monitored in patients who were give intra-lesional bleomycin.

  2 years

Study Arms (2)

Propranolol

ACTIVE COMPARATOR

propranolol with a mean dose of 2mg/kg/day in 2 divided doses for a period of 6 months

Drug: Bleomycin

Bleomycin

EXPERIMENTAL

Bleomycin 15mg diluted in 15 ml of Normal Saline along with a dosage of 0.5 mg/kg for a period of 6 months.

Drug: Bleomycin

Interventions

Bleomycin DRUG

Also known as: Propranolol

Bleomycin; Propranolol

Eligibility Criteria

• Age: 6 Months - 12 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• \. 6 month to 12 yr. of age presenting with infantile hemangioma anywhere on body 2. Both sex included 3. Previously not treated

You may not qualify if:

• On the basis of history and clinical assessment;
• Patients with previous treatment of hemangioma.
• Patients who will be lost to follow up
• Patients who refused to be enrolled in this study
• Patients who experienced hypersensitivity to propranolol/Bleomycin during treatment or had previous known allergy to the drugs.
• Patients who had diagnosed Cardiac disease such as heart failure or AV block.
• Patients with diagnosed Pulmonary disease such as asthma or bronchiolitis.
• History of impaired renal or liver functions.
• Diabetes mellitus

Sponsors & Collaborators

• Shaheed Zulfiqar Ali Bhutto Medical University: lead

Related Publications (1)

• Thayal PK, Bhandari PS, Sarin YK. Comparison of efficacy of intralesional bleomycin and oral propanolol in management of hemangiomas. Plast Reconstr Surg. 2012 Apr;129(4):733e-735e. doi: 10.1097/PRS.0b013e318245e739. No abstract available.

  PMID: 22456397 RESULT

Related Links

• Related Info

MeSH Terms

Conditions

Hemangioma

Interventions

Bleomycin; Propranolol

Condition Hierarchy (Ancestors)

Neoplasms, Vascular Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins; Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Registrar as principal investigator

Study Record Dates

• First Submitted: March 12, 2022
• First Posted: April 14, 2022
• Study Start: May 8, 2015
• Primary Completion: May 9, 2017
• Study Completion: January 1, 2018
• Last Updated: September 13, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Its available