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Cancer drug shows promise for rare skin disease

NCT ID NCT00479934

Disease control Sponsor: University Hospital, Bordeaux Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 whether imatinib, a drug used for certain cancers, can reduce skin hardening in people with severe scleroderma. 28 adults received either imatinib or a placebo for 6 months. The main goal was to see if the drug improved skin thickness and quality of life.

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

28 people

The number who actually took part.

Start date

Dec 2007

Finished

Dec 2010

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

18 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: * More than 18 years old * Documented diagnostic of scleroderma (systemic or cutaneous) * Severe cutaneous sclerodermia or systemic sclerodermia with m-Rodnan score \> 20/51 * Ejection fraction of more than 45 per cent at cardiac ultrasound pre-inclusion study * Woman with efficient contraceptive method during trail treatment and during 3 month after the end of trial treatment * All female patients with reproductive potential must have a negative pregnancy test (serum or urine) within the 7 days prior to enrolment * Affiliated or profit patient of a social security system * Signed informed consent Exclusion Criteria: * new systemic treatment, potentially interfering with disease progression, beginning 3 months prior the start trial treatment * Patient with isolated cutaneous scleroderma treated with a drug potentially interfering with the course of the disease 4 weeks before starting the trial (Systemic corticosteroids, methotrexate, cyclophosphamide, bosentan) * Scleroderma " en coup de sabre " * Severe organ failure or anomaly of blood chemistry/hematology (bilirubin, SGOT, SGPT, creatinine \> 1,5 ´ upper normal limit, polymorphonuclear granulocytes less than 1\*10\*9/l or platelets less than 50\*10\*9/l), * Ongoing cancer * Ejection fraction ≤ 45 per cent at cardiac ultrasound pre inclusion study * myocardial infarction of less than 6 mois at pre inclusion visit * Non controlled chronic illness (diabetes, chronic kidney failure, chronic hepatitis, HIV infection), * Major surgery less than two weeks before inclusion * Pregnancy or lactation * Absence of validated contraception in childbearing women. * Contraindication to imatinib mesylate treatment as specified in product specifications * Non observance anticipated and absence of informed consent

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Conditions

The condition(s) this trial relates to.

diffuse scleroderma localized scleroderma systemic sclerosis

As listed by the trial registrant

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

Scleroderma, localized Scleroderma, systemic

Contacts and locations

Locations

  • Néphrologie et Médecine interne - CH de Valenciennes

    Valenciennes, 59322, France

  • Service de Dermatologie - CHG Libourne

    Libourne, 33500, France

  • Service de Dermatologie - CHG Périgueux

    Périgueux, 24000, France

  • Service de Dermatologie - CHU de Toulouse - Hopital Purpan

    Toulouse, 31059 Toulouse Cedex, France

  • Service de Dermatologie - service de médecine interne et vasculaire - hopital haut Lévêque - av.de magellan

    Pessac, 33604, France

  • Service de Dermatologie et services de médecine interne et vasculaire - Hôpital St André - CHU de Bordeaux

    Bordeaux, 33076, France

  • Service de Médecin interne - Hôpital central

    Nancy, 54035, France

  • Service de Médecine interne - CHU de Tours

    Tours, 37044, France

  • Service de Médecine interne - Hôpital Saint Louis

    Paris, 75475, France

  • Service de Rhumatologie - CHU de Strasbourg

    Strasbourg, 67098, France

  • Service de Rhumatologie, Hôpital Pellegrin-Tondu CHU de Bordeaux

    Bordeaux, 33076, France

  • Service de dermatologie - CHU de Limoges

    Limoges, 87042, France

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