Angioma plans MedDRA version: 12.1 Level: LLT Classification code 10002461 Term: Angioma of skin
Conditions
Interventions
Trade Name: Timolol Gel 1 mg
Product Name: Nyogel LP 0,1%
Product Code: Timolol gel
Pharmaceutical Form: Gel
Sponsors
CHU de Nice
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Children from 6 months to 18 year-old with a port wine stain of the face - Signed agreement of the parents, and of the child if he is old enough to understand - Affiliation to the social health care program. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Port wine stain already treated with a laser or an intense pulsed light - Personal history of asthma or obstructive bronchitis - Severe allergic rhinitis - Sinusal bradycardia, second and third degree atrioventricular block - Cardiac decompensation - Untreated pheochromocytoma - Hypersensitivity to timolol or to one of its component, and/or to other beta-blocker - Concomitant treatment with floctafenine or with sultopride - Oral treatment with beta-blocker, or calcium-channel blocker, or amiodarone
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy one month after the end of the treatment, between the association of timolol gel and pulsed dye laser (PDL), and PDL alone in the treatment of port wine stains in children above 6 months.;Secondary Objective: To study the satisfaction of the parents of the children (and if possible also of the patients themselves depending on their age) on the efficacy and the tolerance of the treatments. To study the possible occurrence of side effects. ;Primary end point(s): The response or therapeutic success will be defined clinically as a marked improvement or a complete regression thanks to an investigator global assessment (IGA) score = 3 (cf. annex 1), one month after the last PDL session. The area treated will be located thanks to anatomical marks. Standardized pictures will be done before and at the end of the study. The evaluation will be blinded and performed by two independent physicians. In case of disagreement a third observer will be required. | — |
Countries
France
Outcome results
None listed