Infantile HemangiomaPhase 2NCT01512173
Study in Infants With Infantile Hemangioma to Compare Propranolol Gel to Placebo
A Phase 2 study testing propranolol gel in people with Infantile Hemangioma, run by Pierre Fabre Dermatology at 17 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 150 days
- Conditions the study is for
- Infantile Hemangioma
- What is being tested?
- propranolol gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 17 sitesin 3 countries
- Study dates
- Jan 2012to May 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 150 days
- All sexes
- No healthy volunteers
- Child
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 locations and contacts
17 sites in 3 countries.
17 sites in 3 countries
France9 sites
CHU Bordeaux Hôpital Pellegrin-Enfants - Unité de Dermatologie pédiatrique
Bordeaux, 33076
Hôpital Saint Vincent de Paul - Dermatologie Pédiatrique
Lille, 59020
CHU Lyon Est Hôpital mère enfant - Consultation des angiomes
Lyon Bron, 69677
CHU Timone - Service de dermatologie
Marseille, 13385
Hôpital Mère-Enfant - Service de Néonatologie et Réanimation Pédiatrique
Nantes, 44093
CHU Necker enfants malades - Service de dermatologie
Paris, 75517
CHU Saint-Etienne Hôpital Nord - Service de dermatologie
Saint-Etienne, 42055
CHU Toulouse Hôpital des enfants - Département cardio-pédiatrique
Toulouse, 31100
Hôpital de Clocheville - Centre de Pédiatrie Gatien
Tours, 37044
Spain5 sites
Hospital Sant Pau de Barcelona
Barcelona, 08025
Hospital Universitario Infantil Niño Jesús
Madrid, 28009
Hospital La Paz
Madrid, 28056
Hospital Universitario Virgen del Rocio
Seville, 41013
Hospital General Universitario de Valencia
Valencia, 46014
Poland3 sites
Pomorskie Centrum Traumatologii im. M. Kopernika w Gdańsku Klinika Chirurgii i Urologii Dzieci i Młodzieży GUMed
Gdansk, 80-803
Uniwersytet Medyczny w Łodzi Klinika Chirurgii i Onkologii Dziecięcej
Lodz, 91-738
Instytut "Pomnik-Centrum Zdrowia Dziecka", Klinika Onkologii
Warsaw, 04-730
About this study
Official title: A Randomised, Double Blind, Controlled, Multicentre 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.
- Conditions
- Infantile Hemangioma
- Being tested
- propranolol gel, Placebo
- 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
- Medical subject headings
- Hemangioma, Capillary, Hemangioma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
propranolol gelDrug
Topical administration twice daily
PlaceboDrug
Topical administration twice daily
| Study group | Role | What they receive |
|---|---|---|
| propranolol gel | Experimental | Not described Receives: Drug: propranolol gel |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: week 12
Secondary outcomes (4)
On-site parent(s) or guardian(s) qualitative assessments of efficacy
categorical endpoints for Infantile Hemangioma evolution (4-points scale)
Measured: week 2 , week 4, week 8, week 12 and week 24
Persistence of efficacy 12 weeks after the end of treatment
Persistence of complete/nearly complete resolution of the Infantile Hemangioma at week 24 compared to week 12.
Measured: Week 24
Safety profile (descriptive analysis of AE)
Measured: 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)
Measured: week 2, week 4, week 8 and week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infantile HemangiomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pierre Fabre Dermatology
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01512173
- Sponsor's protocol ID
- V00400 GL 2 01 1A
- Other IDs
- 2011-003144-50
- Status last verified
- Oct 2014
- First submitted
- 6 Jan 2012
- Last updated
- 30 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double Blind, Controlled, Multicentre Study in Infants With Infantile Hemangioma to Compare Propranolol Gel to Placebo.
- ClinicalTrials.gov ID
- NCT01512173
- Acronym / sponsor ID
- V00400 GL 2 01 1A
- Conditions
- Infantile Hemangioma
- Keywords
- Propranolol gel, Hemangioma, capillary neoplasm, vascular tissue, neoplasm by histologic type, neoplasm, therapeutic uses, pharmacologic actions
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Pierre Fabre DermatologyIndustry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 19 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| propranolol gel | Experimental | Drug: propranolol gel |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 35 to 150 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| propranolol gelTopical administration twice daily | Drug | propranolol gel |
| PlaceboTopical administration twice daily | Drug | Placebo |
Primary outcome
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
4 secondary outcomes
On-site parent(s) or guardian(s) qualitative assessments of efficacy
Time frame: week 2 , week 4, week 8, week 12 and week 24
Persistence of efficacy 12 weeks after the end of treatment
Time frame: Week 24
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
17 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing propranolol gel in people with Infantile Hemangioma, run by Pierre Fabre Dermatology at 17 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in France, Spain, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete/nearly complete resolution of the Infantile Hemangioma at week 12. (time frame: week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2014.