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

Kangstem Biotech

Status: Enrolling

Conditions: Atopic Dermatitis

Treatments: Other: Not applicable(observational study)

Study type: Observational

Funder types: Industry

Identifiers

NCT04087863

K0103

Details and patient eligibility

About

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

Enrollment: 99 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

99 participants in 1 patient group

Atopic Dermatitis

Treatment:

Other: Not applicable(observational study)