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Trial record 7 of 116 for:    Atenolol

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

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ClinicalTrials.gov Identifier: NCT03237637
Recruitment Status : Recruiting
First Posted : August 2, 2017
Last Update Posted : August 28, 2018
Sponsor:
Information provided by (Responsible Party):
Raihan Ashraf, Postgraduate Institute of Medical Education and Research

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.

Condition or disease Intervention/treatment Phase
Infantile Hemangioma Drug: oral propranolol Drug: oral atenolol Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparative Study to Evaluate the Effectiveness of Atenolol and Propranolol in the Treatment of Infantile Hemangiomas
Actual Study Start Date : March 24, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birthmarks

Arm Intervention/treatment
Active Comparator: Group A- Propranolol
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
oral propranolol 1-2mg/kg/day as crushed tablets in two divided doses

Experimental: Group B- Atenolol
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
oral atenolol 0.5-1mg/kg/day as crushed tablets in a single dose




Primary Outcome Measures :
  1. Mean difference in number of patients achieving complete clinical clearance of lesion (PGA Score of 5) in the two groups [ Time Frame: 9 months ]

    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)


  2. Mean difference in number of days required to achieve complete clinical clearance of lesion (PGA Score of 5) in the two groups [ Time Frame: 9 months ]
  3. Mean difference in Hemangioma Activity Score in the two groups [ Time Frame: 9 months ]

    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


  4. Frequency of adverse effects (minor and serious) in the two groups [ Time Frame: 9 months ]

Secondary Outcome Measures :
  1. Mean difference in HIF-1α levels before and after treatment in Group A and Group B [ Time Frame: 9 months ]


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

Inclusion Criteria:

  1. Children diagnosed with problematic infantile hemangiomas

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

Exclusion Criteria:

  1. Infants with heart disease, cardiac arrhythmias
  2. Broncho -obstructive disease.
  3. Premature infants with corrected age less than 40 weeks.
  4. Known hypoglycemia
  5. Diabetes mellitus
  6. Hypertension
  7. Hypotension
  8. Liver failure
  9. Visceral hemangiomas
  10. PHACES syndrome

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): NCT03237637


Contacts
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Contact: Raihan Ashraf, MBBS 9980811682 ext +91 raihanash91@gmail.com
Contact: RAHUL MAHAJAN, MBBS, MD, MNAMS 1722756465 ext +91 drrahulpgi@yahoo.com

Locations
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India
PGIMER Recruiting
Chandigarh, India, 160012
Contact: Raihan Ashraf, MBBS    1722756564 ext +91    raihanash91@gmail.com   
Contact: Rahul Mahajan, MBBS, MD, MNAMS       drrahulpgi@yahoo.com   
Sponsors and Collaborators
Postgraduate Institute of Medical Education and Research

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Responsible Party: Raihan Ashraf, Junior Resident, Department of Dermatology, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier: NCT03237637     History of Changes
Other Study ID Numbers: INT/IEC/2017/322
First Posted: August 2, 2017    Key Record Dates
Last Update Posted: August 28, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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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Atenolol
Hemangioma
Hemangioma, Capillary
Port-Wine Stain
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Neoplasms
Skin Abnormalities
Congenital Abnormalities
Skin Diseases
Propranolol
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Vasodilator Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic beta-1 Receptor Antagonists