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Treatment of Port Wine Stains in Children With Pulsed Dye Laser and Timolol Gel

Phase 3
6 Months
18 Years
Open (Enrolling)

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Trial Information

Treatment of Port Wine Stains in Children With Pulsed Dye Laser and Timolol Gel

Inclusion Criteria:

- Children from 6 months to 18 year-old.

- PWS of the face

- No prior treatement with PDL

- Membership or beneficiary of a national insurance scheme.

- Consent signed by the parents and by the patient if he is old enough to understand

Exclusion Criteria:

- Child with whom the angioma plan was already handled by laser or pulsed lamp

- Histories of asthma or obstructive bronchitis

- severe allergic Rhinitis and hyper bronchial ability to react

- Bradycardie sinusale, block auriculo-ventriculaires of the second or third degree

- unchecked Cardiac insufficiency

- cardiogenic Shock

- untreated Phéochromocytome

- Sentimentality in the timolol or in one of these excipients, and\or in the other

- Taken by floctafénine or by sultopride

- Taken of bétabloquants by oral route, of inhibitors calcic or of amiodarone

- severe peripheral circulatory Disorders(Confusions of Raynaud)

- arterial Low blood pressure

- Pregnancy and feeding

- Absence of effective contraception at the girls old enough to procreate

- Contraindication in the use of cream with lidocaïne and with prilocaïne

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:


Outcome Description:

IGA (investigator global assessment) at 3 or 4 marked improvement or complete clearance one month after the third session. Blinded evaluation by two physicians on standardized photos Colorimetric analysis

Outcome Time Frame:

one month after the third session

Safety Issue:


Principal Investigator

PASSERON Thierry, Pu-Ph

Investigator Role:

Principal Investigator

Investigator Affiliation:

CHU de Nice - Service de Dermatologie - Hôpital de l'Archet - 151 Route de saint-antoine de ginestière 06200 Nice


France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:




Start Date:

January 2011

Completion Date:

May 2012

Related Keywords:

  • Melanoma
  • Melanoma
  • Port-Wine Stain