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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-012740-17-NL

Enrollment

Registered

2009-05-25

Start date

2009-07-30

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Facial fibrofolliculomas in Birt-Hogg-Dubé syndrome

Interventions

Trade Name: Rapamune Product Name: Rapamune Product Code: 53123-88-9 Pharmaceutical Form: Cutaneous solution INN or Proposed INN: SIROLIMUS CAS Number: 53123889 Concentration unit: mg/ml milligram(s)/

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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. ;Secondary Objective: Tolerability and patient satisfaction. ;Primary end point(s): Significant regression of facial fibrofolliculoma in the treated area, due to topical rapamycin.	—

Countries

Netherlands

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026