---
title: A Study to Evaluate the Safety and Efficacy of PAC-14028 Cream in Pediatric Atopic Dermatitis
nct_id: NCT02748993
overall_status: COMPLETED
phase: PHASE1, PHASE2
sponsor: Amorepacific Corporation
study_type: INTERVENTIONAL
primary_condition: Atopic Dermatitis
countries: South Korea
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02748993.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02748993"
ct_last_update_post_date: 2018-11-20
last_seen_at: "2026-05-12T07:26:38.985Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# A Study to Evaluate the Safety and Efficacy of PAC-14028 Cream in Pediatric Atopic Dermatitis

**Official Title:** A Randomized, Double-blind, Placebo-Controlled, Parallel Study to Investigate the Safety, Tolerability, Systemic Exposure and Efficacy of PAC-14028 in Children With Mild to Moderate Pediatric Atopic Dermatitis

**NCT ID:** [NCT02748993](https://clinicaltrials.gov/study/NCT02748993)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE1, PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 56
- **Lead Sponsor:** Amorepacific Corporation
- **Conditions:** Atopic Dermatitis
- **Start Date:** 2016-03
- **Completion Date:** 2018-10
- **CT.gov Last Update:** 2018-11-20

## Brief Summary

This is a phase 1 and 2 study to assess the safety and efficacy of PAC-14028 cream in children with atopic dermatitis.

## Eligibility

- **Minimum age:** 24 Months
- **Maximum age:** 12 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Male and female patients aged 24 months - 12 years
* Who was diagnosed with Atopic Dermatitis according to Haniffin and Rajka criteria, whose affected BSA is over 5% and IGA score is 2 (mild) to 3 (moderate).
* Who has applied stable amount of emollients daily before baseline visit
* Who voluntarily agreed to participate in the study and signed an informed consent form.

Exclusion Criteria:

* Who has skin diseases other than atopic dermatitis or scar in the affected area which can affect the study, determined by the study investigators.
* Who has clinically significant medical history or diseases involving liver, kidney, neurological system, psychial disorder that can affect study results.
* Who has used systemic steroids, antibiotics, immunosuppressants, or received photochemical therapy within 28 days before study drug administration.
* Who has used topical steroids, immunosuppressants or antibiotics to treat atopic dermatitis within 14 days before study drug administration.
* Who has used or is expected to inevitably use prohibited concomitant medications during the study.
* Women who is pregnant /breast-feeding, or who has childbearing potential and does not use available contraceptives.
* Who has dosed other study medications within 30 days before screening.
* Who is determined ineligible for study participation by investigators for any other reasons.
```

## Arms

- **PAC-14028 Cream 0.1%** (EXPERIMENTAL) — PAC-14028 Cream 0.1%, Twice daily for 4 weeks
- **PAC-14028 Cream 0.3%** (EXPERIMENTAL) — PAC-14028 Cream 0.3%, Twice daily for 4 weeks
- **PAC-14028 Cream 1.0%** (EXPERIMENTAL) — PAC-14028 Cream 1.0%, Twice daily for 4 weeks
- **PAC-14028 Cream Vehicle** (PLACEBO_COMPARATOR) — PAC-14028 Cream Vehicle, twice daily for 4 weeks

## Interventions

- **PAC-14028 Cream 0.1%** (DRUG) — Topical application
- **PAC-14028 Cream 0.3%** (DRUG) — Topical application
- **PAC-14028 Cream 1.0%** (DRUG) — Topical application
- **PAC-14028 Cream Vehicle** (DRUG) — Topical application

## Primary Outcomes

- **Success rate of Investigator's Global Assessment (IGA)** _(time frame: 4 weeks)_ — % of patients with IGA score of 0 (clear) or 1 (almost clear)
- **Blood concentrations of PAC-14028** _(time frame: Day 1, Day 28)_ — Blood concentrations of PAC-14028

## Secondary Outcomes

- **Change of IGA (Investigator's Global Assessment)** _(time frame: 1, 2, 4 week(s))_
- **Change of SCORAD (Severity Scoring of Atopic Dermatitis)** _(time frame: 1, 2, 4 week(s))_
- **% Change of EASI (Eczema Area and Severity Index)** _(time frame: 1, 2, 4 week(s))_
- **Patient satisfaction measurement** _(time frame: 4 weeks)_

## Locations (3)

- Chung-ang University Hospital, Seoul, South Korea
- Konkuk University Hospital, Seoul, South Korea
- Seoul National University Hospital, Seoul, South Korea

## Recent Field Changes (last 30 days)

- `locations.chung-ang university hospital|seoul||south korea` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `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.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — 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)_
- `locations.konkuk university hospital|seoul||south korea` — added _(2026-05-12)_
- `locations.seoul national university hospital|seoul||south korea` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT02748993.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT02748993*  
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