Overview

Topical Rapamycin for Fibrofolliculomas

Status:
Completed
Trial end date:
2011-08-01
Target enrollment:
0
Participant gender:
All
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 ones. Secondary we evaluate rapamycin safety, formula acceptance and patient satisfaction.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Maastricht University Medical Center
Collaborator:
Myrovlytis Trust
Treatments:
Everolimus
Sirolimus
Criteria
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.