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Completed

NCT Number: NCT01512173

Study in Infants With Infantile Hemangioma to Compare Propranolol Gel to Placebo

There is an unsatisfied medical need for a first-line treatment of localized uncomplicated proliferating Infantile Hemangioma with a good benefit/risk profile.

Pierre Fabre Dermatologie has developed a new formulation of propranolol (V0400 GL 01A) which is a topical gel adapted to paediatric use.

The objective of this study is to evaluate topical propranolol efficacy and safety in the management of localized hemangioma.

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Key information

Conditions

Infantile Hemangioma Hemangioma Hemangioma, Capillary Neoplasms Neoplasms by Histologic Type Neoplasms, Vascular Tissue

Age range

35 day–150 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CHU Bordeaux Hôpital Pellegrin-Enfants - Unité de Dermatologie pédiatrique, Bordeaux, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

propranolol gel

Drug

Topical administration twice daily

Placebo

Drug

Topical administration twice daily

Primary outcomes

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

    Time frame: week 12

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

Secondary outcomes

  1. On-site parent(s) or guardian(s) qualitative assessments of efficacy

    Time frame: week 2 , week 4, week 8, week 12 and week 24

    categorical endpoints for Infantile Hemangioma evolution (4-points scale)

  2. Persistence of efficacy 12 weeks after the end of treatment

    Time frame: Week 24

    Persistence of complete/nearly complete resolution of the Infantile Hemangioma at week 24 compared to week 12.

  3. Safety profile (descriptive analysis of AE)

    Time frame: Day 0, week 2, week 4, week 8, week 12 and week 24

  4. Local tolerance of the propranolol gel(description over time by treatment group)

    Time frame: week 2, week 4, week 8 and week 12

Sponsors and collaborators

Lead sponsor

Pierre Fabre Dermatology

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jan 19, 2012
Registry last updated
Oct 30, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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