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A Study to Evaluate the Safety and Efficacy of PAC-14028 Cream in Atopic Dermatitis

A Randomized, Open-label, Single Center, Investigator-initiated Clinical Study to Evaluate the Safety and Efficacy of PAC-14028 Cream in Subjects With Mild to Moderate Atopic Dermatitis

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02583022
Enrollment
74
Registered
2015-10-21
Start date
2013-06-30
Completion date
2015-08-31
Last updated
2015-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis

Brief summary

The study is a Phase II, single center, randomized, open-label, placebo-controlled study in male and female subjects, aged ≥ 20 years with mild to moderate atopic dermatitis. All subjects will receive BID topical applications of PAC-14028 cream or vehicle or Elidel cream for up to 4 weeks.

Interventions

DRUGPAC-14028 cream 1.0%

Topical application

DRUGPAC-14028 cream vehicle

Topical application

DRUGElidel cream 1%

Topical application

Sponsors

Amorepacific Corporation
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Male or female patients aged between 20 and 65 years old * Patients with atopic dermatitis, diagnosed according to Hanifin and Rajka diagnostic criteria * SCORAD (SCORing Atopic Dermatitis) Score less than 40

Exclusion criteria

* Patients presenting symptoms of systemic infection at screening * Patients who had been treated with oral steroids, oral antibiotics, systemic phototherapy, or immunosuppressants within the last 1 month prior to the investigational product administration * Patients who had been treated with topical steroids or antibiotics within the last 2 weeks prior to the investigational product administration * Pregnant women or breastfeeding women * Women of childbearing potential or women who are planning a pregnancy during the study

Design outcomes

Primary

MeasureTime frame
SCORing Atopic Dermatitis (SCORAD) indexChange from baseline at Day 28

Secondary

MeasureTime frameDescription
Visual Analogue Scale (VAS) scoreChange from baseline at Day 7, 14 and 28—
Each SCORAD indexChange from baseline at Day 7, 14 and 28—
Transepidermal Water Loss (TEWL) levelChange from baseline at Day 7, 14 and 28—
Eczema Area and Severity Index (EASI) scoreChange from baseline at Day 7, 14 and 28—
Skin Hydration levelChange from baseline at Day 7, 14 and 28Skin hydration was measured using the Corneometer
Success rate to pruritus treatmentChange from baseline at Day 7, 14 and 28—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026