NCT05495425

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Nobelpharma · Industry
• Sex: All
• Age: 3 Years
• Healthy volunteers: Not accepted

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

Conditions

• Tuberous Sclerosis Complex

Interventions

Type	Name	Description
DRUG	NPC-12Y gel	NPC-12Y gel is applied twice a day for 12 weeks. After the double-blind evaluation period, NPC-12Y gel is applied twice a day for 52 weeks.
DRUG	NPC-12Y placebo gel	NPC-12Y placebo gel is applied twice a day for 12 weeks. After the double-blind evaluation period, NPC-12Y gel is applied twice a day for 52 weeks.

Timeline

• Start date: 2022-06-01
• Primary completion: 2024-10-30
• Completion: 2024-10-30
• First posted: 2022-08-10
• Last updated: 2024-11-22

Locations

5 sites across 1 country: Japan