NCT04105517: postHemangiol

Hemangiol, Post Marketing Surveillance Study

Completed Last updated 2 December 2020

What this trial tests

trial in Infantile Hemangioma in 500 participants. Completed in 30 October 2019.

Timeline

1 July 2019

Primary endpoint
20 October 2019

30 October 2019

Quick facts

Lead sponsor	University Hospital, Montpellier
Status	Completed
Study type	OBSERVATIONAL
Enrollment	500
Start date	1 July 2019
Primary completion	20 October 2019
Estimated completion	30 October 2019
Sites	1 location across France

Conditions studied

• Infantile Hemangioma — all drugs for Infantile Hemangioma →

Sponsor

University Hospital, Montpellier

Who can join

Under 18, any sex, with Infantile Hemangioma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Infantile hemangioma is a benign tumor belonging to the group of vascular tumors in the ISSVA classification (International Society for the Study of Vascular Anomalies). The diagnosis is clinical and radiological. The hemangioma appears during the first weeks of life (70% classically within 2 weeks after birth) but can, when it develops in the subcutaneous tissue, appear until the age of 2 to 3 months .

Its evolution is characteristic and is divided into 3 phases with a proliferative phase characterized by a rapid increase in the size of the tumor (up to 6 to 12 months), a phase of stabilization (from 12 to 36 months) with a stopping of the growth of the hemangioma and a regression of its size and a phase of involution with the disappearance of the lesion which may give way to residual fibroadipose tissue, cutaneous telangiectases, scars … The usual complications of haemangiomas occur during the proliferative phase. It is necrosis, ulcerations that can be complicated by bleeding or infection and eventually indelible scarring. Other complications related to the site of development of hemangiomas (amblyopia, astigmatism, upper respiratory obstruction, nasal obstruction, sphincter disorders, eating disorders), hemangiomas destroying structures noble (breast hypodévelopment, alopecia). The aesthetic prognosis can be seriously compromised for facial locations.

Historically, when drug therapy was required, patient management was based on systemic corticosteroids (at doses of 3 to 5 mg / kg / day) in first-line therapy and vincristine as a second-line failure of corticosteroid therapy or when life-threatening is at stake.

In 2014, the high French health authority (HAS) gave Marketing Authorization for Hemangiol 3.75 mg / ml oral solution for the management of infantile proliferative hemangioma requiring first-line systemic treatment, evaluating the actual benefit as important.

The selected indication concerns children from 5 weeks to 5 months with:

* Hemangiomas leading to a vital or functional risk,
* Hemangiomas ulcerated painful and / or not responding to simple care,
* Hemangiomas with a risk of permanent scarring or disfigurement. The 2014 HAS Transparency Commission wishes in its report "to have follow-up data of prescriptions allowing to describe on a representative sample of patients, the characteristics of the treated patients, the indication, the doses and the durations of treatment of this specialty ".

The objective of our study is to describe the use of Hemangiol in current practice in our hospital from 2014 to 2018.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Propranolol: A "Pick and Roll" Team Player in Benign Tumors and Cancer Therapies.
   Albiñana V, Gallardo-Vara E, Casado-Vela J, Recio-Poveda L, et al · · 2022 · cited 14× · PMID 35956154 · DOI 10.3390/jcm11154539
2. Hemangiol in infantile haemangioma: A paediatric post-marketing surveillance drug study.
   Socchi F, Bigorre M, Normandin M, Captier G, et al · · 2021 · cited 5× · PMID 33118199 · DOI 10.1111/bcp.14593