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Laser plus gel: new hope for port wine stains?

NCT ID NCT01272609

Disease control Sponsor: Centre Hospitalier Universitaire de Nice Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether adding timolol gel to pulsed dye laser treatment could improve results for port wine stains on children's faces. Twenty-five children aged 6 months to 18 years were enrolled, but the study was stopped early. The goal was to see if the combination led to better clearing of the stain compared to laser alone.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
timolol 1% gel (topical beta-blocker)
What this could lead to
If it worked, this could point toward a more effective treatment for port wine stains in children, reducing the number of laser sessions needed.
What could go wrong
The study was terminated early and only enrolled 25 children, so results are limited. It is unclear if adding timolol gel provides real benefit over laser alone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

25 people

The number who actually took part.

Started

Feb 2011

Finished

Sep 2012

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 months to 18 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

familial multiple nevi flammei melanoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Melanoma

Contacts and locations

Locations

  • CH de Quimper

    Quimper, France

  • CHU de Bordeaux

    Bordeaux, France

  • CHU de Dijon

    Dijon, France

  • CHU de Nice - 4 avenue Reine Victoria

    Nice, Alpes-Maritimes, 06001, France

  • CHU de Touloluse

    Toulouse, 31 0000, France

  • CHU de reims

    Reims, France

  • Clinique Mathilde

    Rouen, France

  • Clinique Saint-jean Languedoc

    Toulouse, France

  • Clinique de Turin

    Paris, France

  • Hôpital Sévigné

    Cesson-Sévigné, France

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