Topical rapamycin to treat fibrofolliculomas in Birt-Hogg-Dubé syndrome.

• Conditions: Facial fibrofolliculomas in Birt-Hogg-Dubé syndrome

• Registration Number: EUCTR2009-012740-17-NL
• Lead Sponsor: MUMC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05-25
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine whether topical application of rapamycin can lead to reduction in size and/or number of fibrofolliculomas in BHD patients and may prevent the growth of new ones. <br>;Secondary Objective: Tolerability and patient satisfaction. ;Primary end point(s): Significant regression of facial fibrofolliculoma in the treated area, due to topical rapamycin.