Clinical Trials

Inclusion Criteria:

• Male and female patients aged ≥ 6 years and ≤ 65 years on the day informed consent is obtained.
• Patients diagnosed with TSC based on the clinical diagnostic criteria of International Tuberous Sclerosis Complex Consensus Conference 2012 and presenting visible facial angiofibroma.
• An FA severity score of 2 or 3 on the IGA scale.
• Patients or their legal representatives capable of understanding the explanation of the clinical trial and who give written informed consent for participation.
• Patients or their legal representatives able to maintain patient diaries following the instructions of the investigator or sub-investigator.

Exclusion Criteria:

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