Topical rapamycin to treat fibrofolliculomas in Birt-Hogg-Dubé syndrome - Topical rapamycin

niversiteit Maastricht0 个研究点目标入组 20 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

暂无简介。

•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.

•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 during the trial or within 30 days before start of therapy.
•Concomitant disease requiring facial topical immunosuppressive treatment or facial topical drugs that interfere with rapamycin during trial period or within 30 days before start of therapy.
•Tendency to form keloids or hypertrophic scars.
•Drug or alcohol abuse.

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