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A Randomised, Double Blind, Controlled, Multicentre Study in Infants With Infantile Hemangioma to Compare Propranolol Gel to Placebo.


Phase 2
35 Days
150 Days
Open (Enrolling)
Both
Infantile Hemangioma

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Trial Information

A Randomised, Double Blind, Controlled, Multicentre Study in Infants With Infantile Hemangioma to Compare Propranolol Gel to Placebo.


Main

Inclusion Criteria:



- only one proliferating Infantile Hemangioma present anywhere on the body except on
the head, the neck, the hands and on the diaper area, with largest diameter diameter
≥ 1cm and ≤ 5 cm.

Main Exclusion Criteria:

- more than one Infantile Hemangioma with largest diameter ≥ 1cm

- medically unstable health status that may interfere with his/her ability to complete
the study

- Infantile Hemangioma requires, according to Investigator's judgment, a systemic
treatment

- the patient has previously been administered treatment for IH or surgical and/or
medical procedures (e.g. laser therapy) have been performed to treat the IH

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Complete/nearly complete resolution of the Infantile Hemangioma at week 12.

Outcome Description:

Complete/nearly complete resolution of the Infantile Hemangioma at week 12 compared to baseline

Outcome Time Frame:

week 12

Safety Issue:

No

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

V00400 GL 2 01 1A

NCT ID:

NCT01512173

Start Date:

January 2012

Completion Date:

May 2013

Related Keywords:

  • Infantile Hemangioma
  • Propranolol gel
  • Hemangioma
  • capillary neoplasm
  • vascular tissue
  • neoplasm by histologic type
  • neoplasm
  • therapeutic uses
  • pharmacologic actions
  • adrenergic beta-antagonists
  • adrenergic antagonist
  • adrenergics agent
  • neurotransmitter agent
  • molecular mechanism of pharmacological action
  • physiological effects of drugs
  • Hemangioma
  • Hemangioma, Capillary

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