Treatment of Port Wine Stains in Children With Pulsed Dye Laser and Timolol Gel
2 other identifiers
interventional
44
1 country
10
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jan 2011
Shorter than P25 for phase_3
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 7, 2011
CompletedFirst Posted
Study publicly available on registry
January 10, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedMarch 26, 2012
January 1, 2011
Same day
January 7, 2011
March 23, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
IGA
* 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
one month after the third session
Secondary Outcomes (1)
Subjective evaluation of the patients on visual analogical scale
three months
Study Arms (2)
LCP + Timolol
EXPERIMENTALThree 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.
LCP
ACTIVE COMPARATORThree 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
CHU de Nice - 4 avenue Reine Victoria
Nice, Alpes-Maritimes, 06001, France
CHU de Bordeaux
Bordeaux, France
Hôpital Sévigné
Cesson-Sévigné, France
CHU de Dijon
Dijon, France
Clinique de Turin
Paris, France
CH de Quimper
Quimper, France
CHU de reims
Reims, France
Clinique Mathilde
Rouen, France
CHU de Touloluse
Toulouse, 31 0000, France
Clinique Saint-jean Languedoc
Toulouse, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 7, 2011
First Posted
January 10, 2011
Study Start
January 1, 2011
Primary Completion
January 1, 2011
Study Completion
May 1, 2012
Last Updated
March 26, 2012
Record last verified: 2011-01