Spots Global Cancer Trial Database for Clinical Study of NPC-12Y Gel in Patients With Skin Lesions Associated With TSC
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Trial Identification
Brief Title: Clinical Study of NPC-12Y Gel in Patients With Skin Lesions Associated With TSC
Official Title: Placebo-controlled Comparative Study of NPC-12Y Gel in Patients With Skin Lesions Associated With Tuberous Sclerosis Complex
Study ID: NCT05495425
Conditions
Study Description
Brief Summary: The purpose of this study is to investigate the efficacy and safety of NPC-12Y gel compared with placebo for skin lesions associated with tuberous sclerosis.
Detailed Description: This is a Phase 3, placebo-controlled comparative study of NPC-12Y gel in patients with skin lesions associated with tuberous sclerosis complex. Patients who meet all entry criteria for this study will apply NPC-12Y gel or placebo twice a day for 12 weeks. After the double-blind evaluation period, all patients will apply NPC-12Y gel twice a day for 52 weeks. Approximately 40 eligible patients will be enrolled
Eligibility
Minimum Age: 3 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Fujita Health University Hospital, Toyoake, Aichi, Japan
Gunma University Hospital, Maebashi, Gunma, Japan
Osaka University Hospital, Suita, Osaka, Japan
Seirei Hamamatsu General Hospital, Hamamatsu, Shizuoka, Japan
National Hospital Organization Nishi-Niigata Chuo Hospital, Niigata, , Japan
Contact Details
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