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Topical Rapamycin to Treat Fibrofolliculomas in Birt-Hogg-Dubé Syndrome

Phase 3
18 Years
Not Enrolling
Birt-Hogg-Dubé Syndrome

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Trial Information

Topical Rapamycin to Treat Fibrofolliculomas in Birt-Hogg-Dubé Syndrome

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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Significant regression of lesions (reduction of fibrofolliculoma size and count) in the treated area.

Outcome Time Frame:

3 and 6 months

Safety Issue:


Principal Investigator

Maurice van Steensel, Dr.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Dermatology


Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study ID:




Start Date:

January 2010

Completion Date:

August 2011

Related Keywords:

  • Birt-Hogg-Dubé Syndrome
  • Birt-Hogg-Dube Syndrome