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

Amorepacific Corporation74 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Atopic Dermatitis

Interventions

PAC-14028 cream 1.0%DRUG

Topical application

PAC-14028 cream vehicleDRUG

Topical application

Elidel cream 1%DRUG

Topical application

Eligibility

Sex: ALLMin age: 20 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

SCORing Atopic Dermatitis (SCORAD) index

Time frame: Change from baseline at Day 28