Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-25 @ 1:40 AM
NCT ID:
NCT02860494
Eligibility Criteria:
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 or pregnant women, or women on childbearing age without any effective method of contraception during treatment and up to 12 weeks after treatment discontinuation
* Subjects who, in the Investigator's opinion, are unable or unwilling to comply with the protocol.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
0 Years
Maximum Age:
2 Years
Study:
NCT02860494
Study Brief:
Protocol Section:
NCT02860494