Status:
COMPLETED
Topical Rapamycin for Fibrofolliculomas
Lead Sponsor:
Maastricht University Medical Center
Collaborating Sponsors:
Myrovlytis Trust
Conditions:
Birt-Hogg-Dubé Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of the study is 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 one...
Eligibility Criteria
Inclusion
- Minimum age of 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.
Exclusion
- Not capable of informed consent.
- Age under 18 years.
- Pregnancy or failure to comply with contraceptive measures.
- Proven or suspected malignancy of skin or other organs.
- No histological confirmation.
- Skin lesions other than fibrofolliculoma that might worsen under sirolimus such as active infections.
- Not able to comprehend instructions.
- No proven mutation.
- Less than 10 fibrofolliculomas.
- Planned facial surgery in the treatment period.
- Concomitant disease requiring systemic immunosuppressive treatment
- Concomitant disease requiring facial topical immunosuppressive treatment or facial topical drugs that interfere with rapamycin during trail period or in the 30 days before start trial.
- Tendency to form keloids or hypertrophic scars.
- Drug or alcohol abuse.
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00928798
Start Date
January 1 2010
End Date
August 1 2011
Last Update
March 8 2012
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
VU Medical Centre Amsterdam
Amsterdam, Netherlands, 1081 HV
2
Maastricht University Medical Centre
Maastricht, Netherlands, 6229 HX