Clinical Study of NPC-12Y Gel in Patients With Skin Lesions Associated With TSC

Exclusion Criteria

• •1. Patients who (or whose guardian) are hard to apply the investigational drug topically with keeping compliance
• •2. Patients who are hard to be taken pictures of their lesions adequately in such cases that they may not follow instruction of stillness
• •3. Patients with clinical findings such as erosion, ulcer and eruption on or around the lesion of angiofibroma, which may affect assessment of safety or efficacy
• •4. Patients with a history or complication of allergy to the component of the investigational drug (sirolimus)
• •5. Patients who have any infectious disease, cardiac disease, hepatic disease, pulmonary disease, renal disease, hematological disease, or malignant tumor that is considered inappropriate for participation in this clinical study.
• •6. Patients who have complications such as diseases unsuitable for the trial participation, for examples, uncontrolled diabetes, dyslipidemia, etc.
• •7. Patients who have participated in other clinical trial or clinical study, and have taken an investigational or clinical study drug within 6 months before the initial registration
• •8. Patients who used mTOR inhibitors (oral or injectable) other than everolimus within 4 weeks before the initial registration
• •9. Female patients who are pregnant, may be pregnant, or are lactating
• •10. Patients who cannot agree to use appropriate contraception after the date of consent to participate in the clinical study and for the duration of the clinical study (including male patients with a partner of childbearing potential)
• •11. Patients who have received therapy with laser or surgery (including liquid nitrogen therapy and phototherapy) to the lesion of angiofibroma within 6 months before the initial registration
• •12. Other patients who are considered by the investigator as unsuitable for participation in the clinical study