Phase III Trial of Topical Formulation of Sirolimus to Skin Lesions in Patients With Tuberous Scl… (NCT02635789) | Clinical Trial Compass
CompletedPhase 3
Phase III Trial of Topical Formulation of Sirolimus to Skin Lesions in Patients With Tuberous Sclerosis Complex (TSC)
Japan62 participantsStarted 2015-12
Plain-language summary
The purpose of this trial is to evaluate the efficacy and safety of NPC-12G gel (topical formulation of sirolimus) versus placebo gel to facial angiofibroma and other skin lesions in patients with tuberous sclerosis complex (TSC)
Who can participate
Age range3 Years
SexALL
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Inclusion criteria
✓. Male or female patients 3 years old or greater at the time of informed consent
✓. Patients who are diagnosed as definite diagnosis according to diagnostic criteria for tuberous sclerosis complex (International Tuberous Sclerosis Complex Consensus Conference 2012)
✓. Patients with three or more papules of angiofibroma ( \>= 2 mm in diameter with redness in each) on the face at screening tests
✓. Patients who are not suitable for therapy with laser or surgery, or who do not want therapy with laser or surgery
✓. Patients or his/her guardian who give a written informed consent in understanding and willingness after having received enough explanation of the test drug and the current trial plan
Exclusion criteria
✕. Patients who are hard to apply the test drug topically with keeping compliance
✕. 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
✕. Patients who are hard to be taken pictures of their lesions adequately in such cases that they may not follow instruction of stillness
✕. Patients with a history of hypersensitivity to alcohol or allergy to sirolimus
✕. Patients who have complications such as malignant tumor, infection, serious heart disease, hepatic function disorder, renal function disorder or blood disorders which severity are considered by investigator as grade 2 or more severe with reference to ''Concerning classification criteria for seriousness of adverse drug reactions of medical agents''
✕. Patients who have complications such as diseases unsuitable for the trial participation, for examples, uncontrolled diabetes (fasting blood glucose level \>140 mg/dL or postprandial blood glucose level \> 200 mg/dL), dyslipidemia (cholesterol level \> 300 mg/dL or \> 7.75 mmol/L, triglycerides level \> 300 mg/dL or \> 3.42 mmol/L), etc.
✕. Patients who have taken drugs with mTOR inhibitory action including sirolimus, everolimus or temsirolimus within 12 months before the initial registration
✕. Patients who have applied topical tacrolimus on the lesion of angiofibroma within 3 months before the initial registration