Dose-Ranging Efficacy and Safety Study of Topical Rapamycin Cream for Facial Angiofibroma Associated With Tuberous Sclerosis Complex

Exclusion Criteria

• •1. Patients who cannot carry out the treatment plan or follow-up assessment
• •2. Patients with serious skin lesions such as erosions or ulcers
• •3. Patients with known hypersensitivity to any component of the study product
• •4. Patients who have received rapamycin/sirolimus, everolimus, or temsirolimus within 3 months of enrolment
• •5. Patients who received laser therapy or surgical therapy within 6 months prior to trial enrolment
• •6. Patients who participated in any other clinical trial within 3 months prior to the day of enrolment
• •7. Patients judged unsuitable for this clinical trial by the investigator or sub-investigator
• •8. Pregnant or lactating females
• •9. Sexually active females of childbearing potential not using adequate contraception and sexually active males not using adequate contraception
• •10. Patients with immune dysfunction or receiving any form of immunosuppression
• •11. Patients with severe FA, with a score of 4 on the IGA scale
• •12. Patients with an FA severity score of less than 2 on the IGA scale