Comparative Study to Evaluate the Effectiveness of Atenolol and Propranolol in the Treatment of Infantile Hemangiomas

NCT03237637 | Unknown Phase 3

• 1 other identifier: INT/IEC/2017/322
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Through this study, the investigators shall compare the effectiveness of atenolol with propranolol in the treatment of IH. In addition, the investigators shall try to elucidate the mechanism of action of beta blockers by assessing their action on triggers such as hypoxia. The study design will be a parallel group comparative study wherein patients of IH will be randomized into two groups. One group will receive propranolol and the other atenolol for a maximum period of 9 months. The patients will then be followed up regularly for regression of the IH based on Physician global assessment, hemangioma activity score(HAS), serial photography and lesional ultrasonography. Any side effects encountered during the treatment period will also be noted. Also serial measurements of hypoxia inducible factor 1 alpha(HIF-1α) will be made to ascertain the mechanism of action of the drugs.

Conditions

Infantile Hemangioma

Outcome Measures

Primary Outcomes (4)

• Mean difference in number of patients achieving complete clinical clearance of lesion (PGA Score of 5) in the two groups

  Physician Global Assessment Responses to therapy (change of thickness, color, and area) will be recorded on each follow up.The therapeutic responses will be evaluated on a score of 1-5 as follows by an independent dermatologist who will not know the therapies: Score 5: \>90% improvement or complete clinical involution Score 4: excellent improvement(75-90% decrease) Score 3: good improvement(50-74% decrease) Score 2: minimal improvement( 25-49% decrease) Score 1: poor improvement(1-24% decrease) Score 0: failure (no difference or regrowth)

  9 months

• Mean difference in number of days required to achieve complete clinical clearance of lesion (PGA Score of 5) in the two groups

  9 months

• Mean difference in Hemangioma Activity Score in the two groups

  Hemangioma Activity score Patient name: Age: Location of infantile hemangioma: ("Bright red edge" should only be scored when the HOI is not totally "bright red" Skin colored after activity". Do not score in deep HOI (deep swelling) unless the HOI has changed into it after activity) Date Deep swelling: tense HOI(6) 'neutral' HOI at t=0 or less than 50% reduction at follow up(4) \>=50% reduction at follow up (2) No more swelling at follow up (0) Bright red/ shining red HOI(5) OR bright red edge(4) Matt red/reddish purple HOI/ matt red edge(3) Blue HOI or Blue shining through in deep HOI(2) Grey HOI(1) Skin colored after activity(0) Total score: Number of items scored Preliminary HAS= total score/number of items scored Ulcer=\<1cm2 (+0.5) Ulcer 1-25cm2(+1) Ulcer \>=25cm2(+2) HAS= preliminary HAS + ulcer score

  9 months

• Frequency of adverse effects (minor and serious) in the two groups

  9 months

Secondary Outcomes (1)

• Mean difference in HIF-1α levels before and after treatment in Group A and Group B

  9 months

Study Arms (2)

Group A- Propranolol

ACTIVE COMPARATOR

Oral propranolol 1mg/kg/day as crushed tablets, in two divided doses, increased to 2mg/kg/day in two divided doses after 24 hours if tolerated well. Treatment will be stopped at 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.

Drug: oral propranolol

Group B- Atenolol

EXPERIMENTAL

Oral atenolol 0.5mg/kg as a single dose, increased to 1mg/kg as a single dose after 24 hours if tolerated well. Treatment will be stopped at 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.

Drug: oral atenolol

Interventions

oral propranolol DRUG

oral propranolol 1-2mg/kg/day as crushed tablets in two divided doses

Group A- Propranolol

oral atenolol DRUG

oral atenolol 0.5-1mg/kg/day as crushed tablets in a single dose

Group B- Atenolol

Eligibility Criteria

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

You may qualify if:

• Children diagnosed with problematic infantile hemangiomas
• Potentially disfiguring infantile hemangiomas at any site.
• Functionally threatening infantile hemangiomas near the eyes, nose, natural orifices, limbs, genitalia.
• Ulcerated infantile hemangiomas.
• Segmental infantile hemangiomas.
• Uncomplicated progressive infantile hemangiomas with unpredictable future course.
• Age group: less than 1 year of age.
• Either sex
• Multiple hemangiomas

You may not qualify if:

• Infants with heart disease, cardiac arrhythmias
• Broncho -obstructive disease.
• Premature infants with corrected age less than 40 weeks.
• Known hypoglycemia
• Diabetes mellitus
• Hypertension
• Hypotension
• Liver failure
• Visceral hemangiomas
• PHACES syndrome

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

Study Sites (1)

PGIMER

Chandigarh, 160012, India

RECRUITING

MeSH Terms

Conditions

Hemangioma, Capillary

Interventions

Propranolol; Atenolol

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

Central Study Contacts

Raihan Ashraf, MBBS

CONTACT

9980811682; raihanash91@gmail.com

RAHUL MAHAJAN, MBBS, MD, MNAMS

CONTACT

1722756465; drrahulpgi@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Junior Resident, Department of Dermatology

Study Record Dates

• First Submitted: July 18, 2017
• First Posted: August 2, 2017
• Study Start: March 24, 2017
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: August 28, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)