- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00928798
Topical Rapamycin for Fibrofolliculomas
March 7, 2012 updated by: Maastricht University Medical Center
Topical Rapamycin to Treat Fibrofolliculomas in Birt-Hogg-Dubé Syndrome
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 ones.
Secondary we evaluate rapamycin safety, formula acceptance and patient satisfaction.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
19
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Amsterdam, Netherlands, 1081 HV
- VU Medical Centre Amsterdam
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Maastricht, Netherlands, 6229 HX
- Maastricht University Medical Centre
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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 Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: rapamycin
one facial side rapamycin and one facial side placebo
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Application of rapamycin 1 mg/ml oral solution to one predefined skin area on one facial half, twice daily 0,25 ml, during 6 months.
The other facial half will be similarly treated with a placebo.
Other Names:
Application of placebo to one predefined skin area on one facial half, during 6 months.
The other facial half will be similarly treated with rapamycin 1 mg/ml oral solution
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Significant regression of lesions (reduction of fibrofolliculoma size and count) in the treated area.
Time Frame: 3 and 6 months
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3 and 6 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Side effects
Time Frame: 3 and 6 months
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3 and 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Maurice van Steensel, Dr., Department of Dermatology
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2010
Primary Completion (Actual)
February 1, 2011
Study Completion (Actual)
August 1, 2011
Study Registration Dates
First Submitted
June 25, 2009
First Submitted That Met QC Criteria
June 25, 2009
First Posted (Estimate)
June 26, 2009
Study Record Updates
Last Update Posted (Estimate)
March 8, 2012
Last Update Submitted That Met QC Criteria
March 7, 2012
Last Verified
March 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms
- Disease
- Genetic Diseases, Inborn
- Neoplastic Syndromes, Hereditary
- Syndrome
- Birt-Hogg-Dube Syndrome
- Physiological Effects of Drugs
- Anti-Infective Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Anti-Bacterial Agents
- Antibiotics, Antineoplastic
- Antifungal Agents
- Sirolimus
Other Study ID Numbers
- 09-2-058
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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