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Clinical Study of NPC-12Y Gel in Patients With Skin Lesions Associated With TSC

Tuberous Sclerosis Complex Clinical Trial

Official title:
Placebo-controlled Comparative Study of NPC-12Y Gel in Patients With Skin Lesions Associated With Tuberous Sclerosis Complex

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05495425
Study type Interventional
Source Nobelpharma
Contact
Status Active, not recruiting
Phase Phase 3
Start date June 1, 2022
Completion date October 31, 2024
View Details
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