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Safety and Efficacy of FURESTEM-AD Inj. in Patients With Moderate to Severe Chronic Atopic Dermatitis(AD)

NCT03269773 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 197

Last updated 2019-09-12

No results posted yet for this study

Summary

This is multi-center, randomized, double-blind, parallel, placebo-controlled phase III clinical trial to evaluate the efficacy and safety of FURESTEM-AD Inj. for moderate to severe chronic atopic dermatitis

Conditions

Interventions

BIOLOGICAL

FURESTEM-AD Inj.

0.3mL of the following study drug is injected respectively into both upper arms, both thighs, and abdomen (total of 5 regions) as a single dose (total 1.5 mL). Treatment group: FURESTEM-AD® inj. 5.0 X 107 cells/1.5 mL

OTHER

Placebo

0.3mL of the following study drug is injected respectively into both upper arms, both thighs, and abdomen (total of 5 regions) as a single dose (total 1.5mL)

Sponsors & Collaborators

  • Kang Stem Biotech Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-25
Primary Completion
2019-03-30
Completion
2019-06-20

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

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 NCT03269773 on ClinicalTrials.gov