Administration for Placebo Group and Evalution the Safety and Efficacy in Atopic Dermatitis Patients

NCT ID: NCT04087863

Last Updated: 2019-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

99 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-08-29

Study Completion Date

2024-12-31

Brief Summary

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A Multi-center, Open, Single-arm Clinical Trial to Evaluate the Safety and Efficacy of FURESTEM-AD inj. in Patients with Moderate to Severe Chronic Atopic Dermatitis Who Participated in a Placebo Group in K0102 Clinical Trial: 2nd Extension Study of K0102

Detailed Description

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Conditions

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Atopic Dermatitis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Atopic Dermatitis

Not applicable(observational study)

Intervention Type OTHER

Not applicable(observational study)

Interventions

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Not applicable(observational study)

Not applicable(observational study)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Subject who enrolled K0102 Clinical Trial(parent study) and be assigned to a placebo group
2. Subjects who understand and voluntarily sign an informed consent form

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 dermatitis symptom region)
3. Pregnant, breast-feeding women or women who plan to become pregnant during six months after administering the clinical trial medication
4. Subjects who participate in other clinical trial or participated in other clinical trial within 4 weeks
5. In case follow-up is not possible to end of this study period
6. Any other condition which the investigator judges would make patient unsuitable for study participation
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kang Stem Biotech Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The Catholic University of Korea, Seoul ST. Mary's Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Seulbi Lee

Role: CONTACT

+82-2-888-1592

Jeong-hyang Woo

Role: CONTACT

+82-2-888-1592

Facility Contacts

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Sukyung Park

Role: primary

+82-2-2258-8196

Other Identifiers

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K0103

Identifier Type: -

Identifier Source: org_study_id

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