Study in Infants With Infantile Hemangioma to Compare Propranolol Gel to Placebo
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ClinicalTrials.gov Identifier: NCT01512173 |
Recruitment Status :
Completed
First Posted : January 19, 2012
Last Update Posted : October 30, 2014
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Infantile Hemangioma | Drug: propranolol gel Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 82 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Randomised, Double Blind, Controlled, Multicentre Study in Infants With Infantile Hemangioma to Compare Propranolol Gel to Placebo. |
Study Start Date : | January 2012 |
Actual Primary Completion Date : | May 2013 |
Actual Study Completion Date : | May 2013 |
Arm | Intervention/treatment |
---|---|
Experimental: propranolol gel |
Drug: propranolol gel
Topical administration twice daily |
Placebo Comparator: Placebo |
Drug: Placebo
Topical administration twice daily |
- 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
- 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)
- 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.
- Safety profile (descriptive analysis of AE) [ Time Frame: Day 0, week 2, week 4, week 8, week 12 and week 24 ]
- Local tolerance of the propranolol gel(description over time by treatment group) [ Time Frame: week 2, week 4, week 8 and week 12 ]

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Ages Eligible for Study: | 35 Days to 150 Days (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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): NCT01512173

Responsible Party: | Pierre Fabre Dermatology |
ClinicalTrials.gov Identifier: | NCT01512173 |
Other Study ID Numbers: |
V00400 GL 2 01 1A 2011-003144-50 ( EudraCT Number ) |
First Posted: | January 19, 2012 Key Record Dates |
Last Update Posted: | October 30, 2014 |
Last Verified: | October 2014 |
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 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 |