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

Atopic Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02583022
• Other study ID #: TRPV1-AD_IIT
• Status: Completed
• Phase: Phase 2
• First received: September 30, 2015
• Last updated: October 20, 2015
• Start date: June 2013
• Est. completion date: August 2015

Study information

• Verified date: October 2015
• Source: Amorepacific Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: August 2015
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• PAC-14028 cream 1.0%
Topical application
• PAC-14028 cream vehicle
Topical application
• Elidel cream 1%
Topical application

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Amorepacific Corporation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SCORing Atopic Dermatitis (SCORAD) index		Change from baseline at Day 28	No
Secondary	Visual Analogue Scale (VAS) score		Change from baseline at Day 7, 14 and 28	No
Secondary	Success rate to pruritus treatment		Change from baseline at Day 7, 14 and 28	No
Secondary	Eczema Area and Severity Index (EASI) score		Change from baseline at Day 7, 14 and 28	No
Secondary	Each SCORAD index		Change from baseline at Day 7, 14 and 28	No
Secondary	Transepidermal Water Loss (TEWL) level		Change from baseline at Day 7, 14 and 28	No
Secondary	Skin Hydration level	Skin hydration was measured using the Corneometer	Change from baseline at Day 7, 14 and 28	No