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

Last updated: September 10, 2019
Sponsor: Kang Stem Biotech Co., Ltd.
Overall Status: Completed

Phase

3

Condition

Atopic Dermatitis

Rosacea

Allergies & Asthma

Treatment

N/A

Clinical Study ID

NCT03269773
K0102
  • Ages > 19
  • All Genders

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Of either gender, aged >=19

  2. Atopic Dermatitis subjects who are coincident with Hanifin and Rajka diagnosiscriteria

  3. Chronic Atopic Dermatitis that has been present for at least 3 years

  4. EASI>=12 at screening and baseline visit

  5. IGA>=3, SCORAD index>=25, BSA >=10% of AD involvement at screegning and baseline visit

  6. Subjects with documented record of inadequate response to the stable use of topicalatopic dermatitis treatment within 24 weeks before participating in the study, or whomare inadvisable due to safety risks

  7. Subjects who understand and voluntarily sign an informed consent form

Exclusion

Exclusion Criteria:

  1. Subjects with medical history or surgery/procedure history

  2. Subjects with diseases at the time of participation in this study (systemic infection,other serious skin disorders, pigmentation or extensive scarring in atopic dermatitissymptom region)

  3. Subjects who need prohibited medication during clinical period

  4. Pregnant, breast-feeding women or women who plan to become pregnant during this study

  5. Subjects who currently participate in other clinical trial or participated in otherclinical trial within 4 weeks

  6. Any other condition which the investigator judges would make patient unsuitable forstudy participation

Study Design

Total Participants: 197
Study Start date:
April 25, 2018
Estimated Completion Date:
June 20, 2019

Connect with a study center

  • Pusan National University Hospital

    Busan,
    Korea, Republic of

    Site Not Available

  • Chonnam National University Hospital

    Gwangju,
    Korea, Republic of

    Site Not Available

  • Dongguk University Medical Center

    Ilsan,
    Korea, Republic of

    Site Not Available

  • Gachon University Gil Medical Center

    Incheon,
    Korea, Republic of

    Site Not Available

  • Asan Medical Center

    Seoul,
    Korea, Republic of

    Site Not Available

  • Catholic Medical Center

    Seoul, 137-701
    Korea, Republic of

    Site Not Available

  • Chung-Ang University Healthcare System

    Seoul,
    Korea, Republic of

    Site Not Available

  • Hanyang University Medical Center

    Seoul,
    Korea, Republic of

    Site Not Available

  • Samsung Medical Center

    Seoul,
    Korea, Republic of

    Site Not Available

  • Seoul National University Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

  • Ajou University Hospital

    Suwon,
    Korea, Republic of

    Site Not Available

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