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New cream shows promise for rare skin condition

NCT ID NCT03972592

Disease control Sponsor: University Hospital, Tours 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 This study
The trial has finished. Results may not be published yet.
Stopped early
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This status has not been confirmed recently, so it may be out of date.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 a cream containing sirolimus on rare skin growths called microcystic lymphatic malformations, which can ooze, bleed, and cause pain. 55 children and adults applied the cream to one area and a placebo cream to another for 12 weeks. The goal was to see if the sirolimus cream improves the appearance and symptoms better than the placebo.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

55 people

The number who actually took part.

Started

Jun 2019

Finished

Aug 2024

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 years and older

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: * Patients ≥ 6 years * Updated immunization schedule * Diagnosis of primary cutaneous microcystic lymphatic malformation (CMLM) confirmed by histopathological or dermoscopic examination, with or without an underlying malformation or a syndromic malformation (Protée syndrome for instance), responsible for impairment (oozing, bleeding and/or pain) * CMLM ≥ 20 cm2, that can be divided into 2 parts of similar severity * Informed, written consent of the subject and his/her parents if \< 18 years * Rights to French social security (including CMU) Exclusion Criteria: * Patients with lymphatic malformation requiring a continued background therapy (involving deep organs) * Secondary lymphatic malformations (lymphangiectasia post-radiotherapy, etc) * Previous treatment with oral or topical mTOR inhibitors within 12 months before inclusion * Previous treatment with oral or topical steroids within 10 days before inclusion * Immunosuppression (immunosuppressive disease or immunosuppressive treatment) * Ongoing neoplasia * Active chronic infectious disease (Hepatitis B Virus, Hepatitis C Virus, Human Immunodeficiency Virus, etc) * Local fungal, viral (Herpes Simplex Virus, Varicella Zoster Virus, etc) or bacterial infection on the site of the CMLM (based on clinical examination) * Skin necrosis * Known allergy to one of the components of the topical sirolimus preparation or vehicle * Women of child-bearing potential (including teenagers) not using a reliable contraceptive method until the end of the study * Pregnant or breastfeeding women * Subject already involved in another therapeutic trial

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Conditions

The condition(s) this trial relates to.

Lymphatic Abnormalities lymphatic malformation microcystic lymphatic malformation vascular malformation

As listed by the trial registrant

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

Lymphatic malformation Vascular malformations

Contacts and locations

Locations

  • ANGERS

    Angers, France

  • BORDEAUX

    Bordeaux, France

  • CAEN

    Caen, France

  • DIJON

    Dijon, France

  • LYON AD

    Bron, France

  • LYON PED

    Bron, France

  • Lariboisiere

    Paris, France

  • Marseille

    Marseille, France

  • Montpellier

    Montpellier, France

  • NANCY

    Vandœuvre-lès-Nancy, France

  • NANTES

    Nantes, France

  • NECKER

    Paris, France

  • NICE

    Nice, France

  • QUIMPER

    Quimper, France

  • RENNES

    Rennes, France

  • TOULOUSE

    Toulouse, France

  • TOURS

    Tours, France

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