Topical Rapamycin for Fibrofolliculomas

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2011-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Birt-Hogg-Dubé Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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rapamycin

one facial side rapamycin and one facial side placebo

Group Type EXPERIMENTAL

Rapamycin

Intervention Type DRUG

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.

placebo

Intervention Type DRUG

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

Interventions

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Rapamycin

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.

Intervention Type DRUG

placebo

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

Intervention Type DRUG

Other Intervention Names

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Rapamune Sirolimus

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No