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

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 Overview

• Status: Completed
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: PAC-14028 cream 1.0%; Drug: PAC-14028 cream vehicle; Drug: Elidel cream 1%

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PAC-14028 cream 1.0%; PAC-14028 cream 1.0%, Twice daily for 4 weeks	Drug: PAC-14028 cream 1.0%; Topical application
Placebo Comparator: PAC-14028 cream vehicle; PAC-14028 cream vehicle, Twice daily for 4 weeks	Drug: PAC-14028 cream vehicle; Topical application
Active Comparator: Elidel cream 1%; Elidel cream 1%, Twice daily for 4 weeks	Drug: Elidel cream 1%; Topical application

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
SCORing Atopic Dermatitis (SCORAD) index	Change from baseline at Day 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Each SCORAD index		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	Skin hydration was measured using the Corneometer	Change from baseline at Day 7, 14 and 28

Collaborators and Investigators

• Sponsor: Amorepacific Corporation

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: September 30, 2015
• First Submitted That Met QC Criteria: October 20, 2015
• First Posted (Estimate): October 21, 2015

Study Record Updates

• Last Update Posted (Estimate): October 21, 2015
• Last Update Submitted That Met QC Criteria: October 20, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Immunosuppressive Agents; Immunologic Factors; Dermatologic Agents; Calcineurin Inhibitors; Pimecrolimus
• Other Study ID Numbers: TRPV1-AD_IIT