---
title: Administration for Placebo Group and Evalution the Safety and Efficacy in Atopic Dermatitis Patients
nct_id: NCT04087863
overall_status: UNKNOWN
sponsor: Kang Stem Biotech Co., Ltd.
study_type: OBSERVATIONAL
primary_condition: Atopic Dermatitis
countries: South Korea
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04087863.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04087863"
ct_last_update_post_date: 2019-09-12
last_seen_at: "2026-05-12T06:38:26.713Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Administration for Placebo Group and Evalution the Safety and Efficacy in Atopic Dermatitis Patients

**Official Title:** 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

**NCT ID:** [NCT04087863](https://clinicaltrials.gov/study/NCT04087863)

## Key Facts

- **Status:** UNKNOWN
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 99
- **Lead Sponsor:** Kang Stem Biotech Co., Ltd.
- **Conditions:** Atopic Dermatitis
- **Start Date:** 2019-08-29
- **Completion Date:** 2024-12-31
- **CT.gov Last Update:** 2019-09-12

## Brief Summary

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

## Eligibility

- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **Atopic Dermatitis**

## Interventions

- **Not applicable(observational study)** (OTHER) — Not applicable(observational study)

## Primary Outcomes

- **Safety Assessment (Rate of Adverse Event, Number of Participants with Adverse Event)** _(time frame: 5 years)_

## Secondary Outcomes

- **Percentage of subjects whose Eczema Area and Severity Index (EASI) was decreased from baseline by more than 75% at each visit (EASI-75)** _(time frame: 3 years)_
- **Percentage of subjects whose Eczema Area and Severity Index (EASI) was decreased from baseline by more than 50% at each visit (EASI-50)** _(time frame: 3 years)_
- **Rate of change in EASI from baseline** _(time frame: 3 years)_
- **Change in EASI from baseline** _(time frame: 3 years)_
- **Percentage of subjects whose Investigator's Global Assessment (IGA) score at each visit is 0 or 1** _(time frame: 3 years)_
- **Percentage of subjects whose IGA at each visit is 0 or 1, or improved to 2 or higher** _(time frame: 3 years)_
- **Percentage of subjects whose SCORing Atopic Dermatitis (SCORAD) INDEX was decreased from baseline by more than 50% at each visit (SCORAD-50)** _(time frame: 3 years)_
- **Rate of change in SCORAD index from baseline at each visit** _(time frame: 3 years)_
- **Change in SCORAD index from baseline at each visit** _(time frame: 3 years)_
- **Rate of change in Extent, Intensity of lesions and subject symptoms for SCORAD index from baseline at each visit** _(time frame: 3 years)_
- **Change in Extent, Intensity of lesions and subject symptoms for SCORAD index from baseline at each visit** _(time frame: 3 years)_
- **Change in total serum Immunoglobulin E(IgE) from baseline** _(time frame: 3 years)_
- **Rate of change in total serum Immunoglobulin E(IgE) from baseline** _(time frame: 3 years)_

## Locations (1)

- The Catholic University of Korea, Seoul ST. Mary's Hospital, Seoul, South Korea — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.the catholic university of korea, seoul st. mary's hospital|seoul||south korea` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT04087863.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT04087863*  
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