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

NCT05495425 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2024-11-22

No results posted yet for this study

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.

Conditions

  • Tuberous Sclerosis Complex

Interventions

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.

Sponsors & Collaborators

  • Nobelpharma

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-01
Primary Completion
2024-10-30
Completion
2024-10-30

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05495425 on ClinicalTrials.gov