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.