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

Phase 2

Completed

• Conditions: Atopic Dermatitis
• Interventions: Drug: Elidel cream 1%; Drug: PAC-14028 cream vehicle; Drug: PAC-14028 cream 1.0%

• Registration Number: NCT02583022
• Lead Sponsor: Amorepacific Corporation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Primary Completion: 2014-01
• Study Completion: 2015-08
• Study First Submitted: 2015-09-30
• Status Verified: 2015-10
• Study First Submitted QC: 2015-10-20
• Last Update Submitted: 2015-10-20
• Study First Posted: 2015-10-21
• Last Update Posted: 2015-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Elidel cream 1%	Elidel cream 1%	Elidel cream 1%, Twice daily for 4 weeks
PAC-14028 cream vehicle	PAC-14028 cream vehicle	PAC-14028 cream vehicle, Twice daily for 4 weeks
PAC-14028 cream 1.0%	PAC-14028 cream 1.0%	PAC-14028 cream 1.0%, Twice daily for 4 weeks

Primary Outcome Measures

Name	Time	Method
SCORing Atopic Dermatitis (SCORAD) index	Change from baseline at Day 28

Secondary Outcome Measures

Name	Time	Method
Each SCORAD index	Change from baseline at Day 7, 14 and 28
Visual Analogue Scale (VAS) score	Change from baseline at Day 7, 14 and 28
Success rate to pruritus treatment	Change from baseline at Day 7, 14 and 28
Eczema Area and Severity Index (EASI) score	Change from baseline at Day 7, 14 and 28
Transepidermal Water Loss (TEWL) level	Change from baseline at Day 7, 14 and 28
Skin Hydration level	Change from baseline at Day 7, 14 and 28	Skin hydration was measured using the Corneometer