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

Pierre Fabre

Status and phase: Completed; Phase 2

Conditions: Infantile Hemangioma

Treatments: Drug: propranolol gel; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01512173

V00400 GL 2 01 1A

2011-003144-50 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 82 patients

Sex: All

Ages: 35 to 150 days old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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82 participants in 2 patient groups, including a placebo group

propranolol gel

Experimental group

Treatment:

Drug: propranolol gel

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo