Study in infants with infantile hemangioma to compare propranolol gel to placebo.

Phase 1

Active, not recruiting

• Conditions: Proliferating localised uncomplicated infantile hemangioma not requiring systemic therapy; MedDRA version: 14.0 Level: LLT Classification code 10019400 Term: Hemangioma of skin and subcutaneous tissue System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2011-003144-50-FR
• Lead Sponsor: Pierre Fabre Dermatologie, Represented by Institut de Recherche Pierre Fabre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09-20
• Study Completion: 2013-05-09
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: Not specified
• Target Recruitment: 80

Inclusion Criteria

A patient will be eligible if he/she meets all of the following criteria:
• Written informed consent(s) for study participation and the use of the patient’s images are obtained according to national regulations from the patient’s parent(s) or legal guardian(s) prior to performing any study procedures.
• The patient is 35 to 150 days old inclusive, at inclusion.
• Only one proliferating IH is present anywhere on the body except on the head, the neck, the hands and on the diaper area, with largest diameter = 1cm and = 3 cm.
• If required by national regulations, patient registered with a social security or health insurance system and/or whose parent(s) or legal guardian(s) is (are) registered with a social security or health insurance system.

Are the trial subjects under 18? yes
Number of subjects for this age range: 80
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

A patient will be ineligible if he/she meets any of the following criteria:
• The patient has got more than one IH with largest diameter = 1cm
• The patient has a medically unstable health status that may interfere with his/her ability to complete the study.
• IH requires, according to Investigator’s judgment, a systemic treatment.
• The patient is known to have one or more of the following medical conditions: bronchial asthma; bronchospasm; hypoglycaemia; untreated phaeochromocytoma; hypotension; second or third degree heart block; cardiogenic shock; metabolic acidosis; bradycardia; severe peripheral arterial circulatory disturbances; Raynaud’s phenomenon; sick sinus syndrome; uncontrolled heart failure or Prinzmetal’s angina.
• The patient has received at least one of the following prohibited medications within 14 days before randomisation:
- Cardiovascular treatments: anti-arrhythmics, calcium channel blockers, ACE inhibitors, inotropic agents, vasodilators (hydralazine hydrochloride…), clonidine…
- Hypoglycaemic agents or drugs able to induce hypoglycaemia.
- Non-steroid anti-inflammatory drugs (NSAIDs) at anti-inflammatory dose.
- Sympathomimetic agents and parenteral adrenaline.

• The patient has previously been administered systemic, intralesional or topical corticosteroids, vincristine, alfa-interferon, imiquimod, propranolol or other beta-blockers.
• 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.
• The patient’s mother has been breastfeeding the patient while she was also being treated with beta-blockers (including propranolol) or, she has been breastfeeding the patient within 14 days of randomisation while she was also being treated with systemic (oral, intra-venous or intra-muscular) corticosteroids, vincristine or alfa-interferon.
• The patient is known to have a hypersensitivity to propranolol and/or any other beta-blockers and/or any ingredient of the test product.
• Patient with congenital hemangioma
• Patient with ulcerated IH.
• Patient with heart rate < 80 bpm at inclusion
• Patient with blood pressure < 50/30 mmHg at inclusion
• Patient with known renal impairment.
• Patient with known cardiac conditions that may predispose to heart block.
• The patient is participating in another clinical study or has received treatment with known remnant effects or undergone investigation liable to interfere with the present clinical trial.
• The patient has sibling already participating to this clinical study
• Parent(s) or legal guardian(s) who cannot be contacted by telephone in case of emergency.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified