Topical Everolimus in Patients With Tuberous Sclerosis Complex

Inclusion Criteria: * Patients over the age of 2 years * With definite or possible diagnosis of TSC * With at least 3 FA, diagnosed by a dermatologist * Patients (or parents or legal guardians) who have provided written informed consent prior to participation in the study * Willing and able to comply with study requirements * With negative blood pregnancy test at the screening visit and using effective contraceptive methods for women of childbearing potential, up to 12 weeks after treatment discontinuation * Covered by national health insurance Exclusion Criteria: * Systemic treatment by sirolimus, everolimus, or any other immunosuppressive drug, during the previous 6 months * Use of topical tacrolimus or sirolimus on the face, during the previous 6 months * Destructive treatment (laser therapy, surgery, cryotherapy) of facial angiofibromas during the previous 6 months * Concomitant use of topical treatments that could affect facial erythema (e.g. Brimonidine) * Known internal organ involvement requiring systemic mTOR inhibitor in the next 6 months * Immunosuppression (immunosuppressive disease or immunosuppressive treatment) * Known chronic infectious disease Known hypersensitivity to mTOR inhibitor * Neutropenia \< 1000/mm3 * Thrombopenia \< 75,000/mm3 * Chronic renal insufficiency (estimated Glomerular Filtration Rate \< 60 mls/min) * Chronic liver disease (SGOT or SGPT \> 3 times upper normal limit) * Uncontrolled dyslipidaemia * Uncontrolled diabetes * Brest feeding o…