Placebo-controlled comparative study of NPC-12Y oily gel in patients with skin lesions associated with tuberous sclerosis complex

INTERVENTION: Either NPC‐12Y gel or placebo gel was evenly applied to skin lesions on the face or head twice daily. CONDITION: Tuberous Sclerosis Complex PRIMARY OUTCOME: Improvements in angiofibroma assessed by IRC at 12 weeks after the start of administration SECONDARY OUTCOME: Assessment of efficacy; 1) Improvements and improvement rate in angiofibroma assessed by IRC (except the primary outcome); 2) Improvements and improvement rate in the color (reddishness) of angiofibroma assessed by IRC; 3) Improvements and improvement rate in the size of angiofibroma assessed by IRC; 4) Changes in Inde Xof Facial Angiofibromas (IFA) score over time by investigators; 5) Changes in shagreen Patch surface and volume over time; 6) Changes in Ungual fibromas surface over time ; 7) Patient satisfaction; ; Assessment of safety; 1)Incidence of adverse events and adverse drug reactions; 2)Serious adverse events and adverse drug reactions; 3)Significant adverse events and adverse drug reactions; 4)Laboratory findings and vital signs; 5)Sirolimus / everolimus blood concentration INCLUSION CRITERIA: (1) Male or female patients 3 years old or greater at the time of informed consent (2) Patients who are diagnosed as definite diagnosis according to diagnostic criteria for tuberous sclerosis comple X(International Tuberous Sclerosis Comple XConsensus Conference 2012) (3) Patients with three or more reddish papules of angiofibroma ( >= 2 mm in diameter) on the face at screening tests (4) Patients who are not suitable for therapy with laser or surgery (including liquid nitrogen therapy and phototherapy) for angiofibroma, or who do not want therapy with laser or surgery (5) Patients who are being treated with Rapalimus gel 0.2% (NPC‐12G Gel 0.2%) and who are able to and agree to a withdrawal of at least 4 weeks prior to enrollment in this study. (6) Patients who (or whose guardian) give a written informed consent in understanding and willingness after having received enough explanation regarding the study participation.