EUCTR2009-012740-17-NLActive, not recruitingNot Applicable
Topical rapamycin to treat fibrofolliculomas in Birt-Hogg-Dubé syndrome.
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- MUMC
- Enrollment
- 20
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Age over 18 years.
- •At least 10 facial fibrofolliculomas, histologically confirmed.
- •Entered in a screening program and free of malignancy as determined during screening (already had a baseline MRI or CT-scan).
- •Being able to understand instructions.
- •Mutation status must be known.
- •For females: not pregnant and willing to use both oral and barrier contraceptives during the treatment period.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •Niet in staat tot informed consent.
- •Leeftijd onder 18.
- •Zwangerschap of niet bereid tot gebruik van anticonceptiva.
- •Bewezen of verdachte maligniteit van de huid of andere organen.
- •Geen histologische bevestiging.
- •Huidafwijkingen (andere dan fibrofolliculomen) die kunnen verergeren bij rapamycine zoals infectieuze huidaandoeningen.
- •Niet in staat intructies te begrijpen/op te volgen.
- •Geen bewezen mutatie.
- •Minder dan 10 fibrofolliculomen.
- •Geplande aangezichtschirurgie in behandelperiode.
- •Noodzaak tot gebruiken van topische of systemische middelen die interactie hebben met rapamycine gedurende de trial of in de laatste 30 dagen hiervoor.
- •Lever- en nierfunctiestoornissen, verhoogd cholesterol/triglyceriden
- •Drugs- en/of alcohol misbruik
Investigators
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