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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Centre Hospitalier Universitaire de Nice.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT01272609
First received: January 7, 2011
Last updated: March 23, 2012
Last verified: January 2011

January 7, 2011
March 23, 2012
January 2011
January 2011   (final data collection date for primary outcome measure)
IGA [ Time Frame: one month after the third session ] [ Designated as safety issue: No ]
  • 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
IGA [ Time Frame: one month after the third session ] [ Designated as safety issue: No ]
  • 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
Complete list of historical versions of study NCT01272609 on ClinicalTrials.gov Archive Site
Subjective evaluation of the patients on visual analogical scale [ Time Frame: three months ] [ Designated as safety issue: No ]
Subjective evaluation of the patients on visual analogical scale
Subjective evaluation of the patients (on visual analogical scale) [ Time Frame: once time ] [ Designated as safety issue: No ]
Subjective evaluation of the patients (on visual analogical scale)
Not Provided
Not Provided
 
Treatment of Port Wine Stains in Children With Pulsed Dye Laser and Timolol Gel
Treatment of Port Wine Stains in Children With Pulsed Dye Laser and Timolol Gel

Pulsed dye laser (PDL)is the gold standard treatment of port wine stains (PWS). However, many sessions are required and failure or relapses are not uncommon. It has been demonstrated that a neoangiogenesis occurs after PDL, explaining at least partially those failure. The objective of this study is to evaluate the use of a topical beta-blocker (timolol 1% gel) as a combination treatment with PDL for treating PWS.

Methods. Prospective multicenter study comparing PDL alone to PDL + timolol. Sessions of PDL will be performed once a month for 3 months. One group will be treated with PDL alone and the other will also applied timolol 1% gel twice a day during treatment. The evaluation will be done one month after the third session.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Melanoma
  • Drug: Timolol + LCP
    Three sessions of LCP in 595nm (diameter of spot 7mm; duration of shooting 1,5ms; Fluence 8 J / cm ² if LCP of Candela © or 7 J / cm ² if LCP of Cynosure ©) spaced out of 1 month. Twice-daily applications on the zone treated by the LCP of timolol frost and will be begun that very evening by the first session and will be pursued 15j after the 3rd session of LCP. The maximum surface of treatment will be 100 cms ².
  • Device: LCP
    Three sessions of LCP in 595nm (diameter of spot 7mm; duration of shooting 1,5ms; Fluence 8 J / cm ²if LCP of Candela © or 7 J / cm ²if LCP of Cynosure © spaced out of 1 month.
  • Experimental: LCP + Timolol
    Three sessions of LCP in 595 nm (diameter of spot 7mm; duration of shooting 1,5 ms; Fluence 8 J / cm ²if LCP of Candela © or 7 J / cm ² if LCP of Cynosure ©) spaced out of 1 month. Twice-daily applications on the zone treated by the LCP of timolol frost and will be begun that very evening by the first session and will be pursued 15j after the 3rd session of LCP. The maximum surface of treatment will be 100 cms ².
    Intervention: Drug: Timolol + LCP
  • Active Comparator: LCP
    Three sessions of LCP in 595 nm (diameter of spot 7mm; duration of shooting 1,5ms; Fluence 8 J / cm ² if LCP of Candela © or 7 J / cm ² if LCP of Cynosure © spaced out of 1 month.
    Intervention: Device: LCP
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
44
May 2012
January 2011   (final data collection date for primary outcome measure)

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 bétabloquants
  • 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
Both
6 Months to 18 Years
No
Contact: PASSERON Thierry, PU-PH +33492039224 passeron.t@chu-nice.fr
France
 
NCT01272609
10-PP-11, 2010-022440-20
No
Centre Hospitalier Universitaire de Nice
Centre Hospitalier Universitaire de Nice
Not Provided
Principal Investigator: PASSERON Thierry, Pu-Ph CHU de Nice - Service de Dermatologie - Hôpital de l'Archet - 151 Route de saint-antoine de ginestière 06200 Nice
Centre Hospitalier Universitaire de Nice
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP