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MelanomaPhase 3NCT01272609

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

A Phase 3 study testing Timolol + LCP and LCP in people with Melanoma, run by Centre Hospitalier Universitaire de Nice at 10 sites in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 6 months to 18 years
Conditions the study is for
Melanoma
What is being tested?
Timolol + LCP and LCP
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
10 sitesFrance
Study dates
16 Feb 2011to 24 Sep 2012
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 months to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 15Show fewer
  • 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

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

France10 sites

  • CHU de Bordeaux

    Bordeaux

  • Hôpital Sévigné

    Cesson-Sévigné

  • CHU de Dijon

    Dijon

  • CHU de Nice - 4 avenue Reine Victoria

    Nice, Alpes-Maritimes, 06001

  • Clinique de Turin

    Paris

  • CH de Quimper

    Quimper

  • CHU de reims

    Reims

  • Clinique Mathilde

    Rouen

  • CHU de Touloluse

    Toulouse, 31 0000

  • Clinique Saint-jean Languedoc

    Toulouse

Other trials in France

About this study

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.

Conditions
Melanoma
Being tested
Timolol + LCP, LCP
Medical subject headings
Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Timolol + LCPDrug

    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.

  • LCPDevice

    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.

Study groups in NCT01272609
Study groupRoleWhat they receive
LCP + TimololExperimentalThree 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.
Receives: Drug: Timolol + LCP
LCPActive 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.
Receives: Device: LCP

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: one month after the third session

Secondary outcomes (1)

  1. Subjective evaluation of the patients on visual analogical scale

    Subjective evaluation of the patients on visual analogical scale

    Measured: three months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jan 2011 (estimated)
  2. Study start16 Feb 2011
  3. Primary completion24 Sep 2012
  4. Study completion24 Sep 2012

Why it stopped: Rupture du traitement

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01272609
Sponsor's protocol ID
10-PP-11
Other IDs
2010-022440-20
Status last verified
Jun 2014
First submitted
7 Jan 2011
Last updated
17 Jun 2026
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Timolol + LCP and LCP in people with Melanoma, run by Centre Hospitalier Universitaire de Nice at 10 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Rupture du traitement). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

IGA (time frame: one month after the third session). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01272609.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.

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