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
Recruitment status was Recruiting
Sponsor:
Centre Hospitalier Universitaire de Nice
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
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Melanoma |
Drug: Timolol + LCP Device: LCP |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Treatment of Port Wine Stains in Children With Pulsed Dye Laser and Timolol Gel |
Resource links provided by NLM:
Further study details as provided by Centre Hospitalier Universitaire de Nice:
Primary Outcome Measures:
- 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
Secondary Outcome Measures:
- 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
| Estimated Enrollment: | 44 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | May 2012 |
| Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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.
|
|
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.
|
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.
|
Eligibility| Ages Eligible for Study: | 6 Months to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01272609
Contacts
| Contact: PASSERON Thierry, PU-PH | +33492039224 | passeron.t@chu-nice.fr |
Locations
| France | |
| CHU de Nice - 4 avenue Reine Victoria | Recruiting |
| Nice, Alpes-Maritimes, France, 06001 | |
| Contact: PASSERON Thierry, PU-PH +33492039224 passeron.t@chu-nice.fr | |
| Principal Investigator: Passeron Thierry, Pu-PH | |
| CHU de Bordeaux | Recruiting |
| Bordeaux, France | |
| Contact: Labreze Christine, pu-ph 'christine.labreze@chu-bordeaux.fr' | |
| Sub-Investigator: Labreze Christine, pu-ph | |
| Hôpital Sévigné | Recruiting |
| Cesson Sévigné, France | |
| Contact: Toubel Gérard, Phd 'gerard.toubel@wanadoo.fr' | |
| Sub-Investigator: TOUBEL Gérard, phd | |
| CHU de Dijon | Recruiting |
| Dijon, France | |
| Contact: Vabres Pierre, PhD pierre.vabres@chu-dijon.fr | |
| Sub-Investigator: Vabres Pierre, PhD | |
| Clinique de Turin | Recruiting |
| Paris, France | |
| Contact: Mazer Jean-Marc, Phd 'jmmazer@wanadoo.fr' | |
| Sub-Investigator: Mazer Jean-Marc, PhD | |
| CH de Quimper | Recruiting |
| Quimper, France | |
| Contact: Plantin Patrick, phd 'p.plantin@ch-cornouaille.fr' | |
| Sub-Investigator: Plantin Patrick, PhD | |
| CHU de reims | Recruiting |
| Reims, France | |
| Contact: ESCHARD Christine, Pu-Ph 'ceschard.chu-reims@medical51.apicrypt.org' | |
| Sub-Investigator: Eschard Christine, Pu-Ph | |
| Clinique Mathilde | Recruiting |
| Rouen, France | |
| Contact: Rossi Bernard, PHD 'bernard.rossi@clinique-clinique.orange.fr' | |
| Sub-Investigator: Rossi bernard, PHD | |
| Clinique Saint-jean Languedoc | Recruiting |
| Toulouse, France | |
| Contact: Dahan serge, phd 'dahan.serge@wanadoo.fr' | |
| Sub-Investigator: Dahan Serge, phd | |
| CHU de Touloluse | Recruiting |
| Toulouse, France, 31 0000 | |
| Contact: MAZEREEUW juliette, Pu-Ph 'mazereeuw-hautier.j@chu-toulouse.fr' | |
| Sub-Investigator: MAZEREEUW juliette, Pu-Ph | |
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Investigators
| 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 |
More Information
No publications provided
| Responsible Party: | Centre Hospitalier Universitaire de Nice |
| ClinicalTrials.gov Identifier: | NCT01272609 History of Changes |
| Other Study ID Numbers: | 10-PP-11, 2010-022440-20 |
| Study First Received: | January 7, 2011 |
| Last Updated: | March 23, 2012 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Additional relevant MeSH terms:
|
Melanoma Port-Wine Stain Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas Skin Abnormalities Congenital Abnormalities Skin Diseases |
Timolol Adrenergic beta-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Anti-Arrhythmia Agents Cardiovascular Agents Therapeutic Uses Antihypertensive Agents |
ClinicalTrials.gov processed this record on May 21, 2013