Study in Infants With Infantile Hemangioma to Compare Pro... | NCT01512173

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

NCT01512173

Sponsor

Pierre Fabre Dermatology

Status

Completed

Last Update Posted

Oct 30, 2014Estimated

Enrollment

82Actual

Phase

Phase 2

Conditions

Infantile Hemangioma

Interventions

propranolol gel
Placebo

Countries

France
Poland
Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2011-003144-50	EudraCT Number

Status Module

Record Verification Date

Oct 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2012

Primary Completion Date

May 2013Actual

Completion Date

May 2013Actual

First Submitted Date

Jan 6, 2012

First Submission Date that Met QC Criteria

Jan 13, 2012

First Posted Date

Jan 19, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 29, 2014

Last Update Posted Date

Oct 30, 2014Estimated

Description Module

Brief Summary

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.

Detailed Description

Not provided

Conditions Module

Conditions

Infantile Hemangioma

Keywords

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

82Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
propranolol gel	Experimental		Drug: propranolol gel
Placebo	Placebo Comparator		Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
propranolol gel	Drug	Topical administration twice daily	propranolol gel

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Complete/nearly complete resolution of the Infantile Hemangioma at week 12.	Complete/nearly complete resolution of the Infantile Hemangioma at week 12 compared to baseline	week 12

Secondary Outcomes

Measure	Description	Time Frame
On-site parent(s) or guardian(s) qualitative assessments of efficacy	categorical endpoints for Infantile Hemangioma evolution (4-points scale)	week 2 , week 4, week 8, week 12 and week 24
Persistence of efficacy 12 weeks after the end of treatment

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

35 Days

Maximum Age

150 Days

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU Bordeaux Hôpital Pellegrin-Enfants - Unité de Dermatologie pédiatrique		Bordeaux		33076	France

Condition Browse Module

MeSH Terms

ID	Term
D018324	Hemangioma, Capillary
D006391	Hemangioma
D009369	Neoplasms

Ancestor Terms

ID	Term
D009383	Neoplasms, Vascular Tissue
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided