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

Atopic Dermatitis Clinical Trial

Official title:

Multi Center, Randomized, Double-blind, Placebo-controlled Parallel-group, Phase II Clinical Trial to Evaluate the Safety and Efficacy of PAC-14028 Cream in Mild to Moderate Atopic Dermatitis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02757729
• Other study ID #: AP-TRPV1-PII_04
• Status: Completed
• Phase: Phase 2
• First received: April 20, 2016
• Last updated: September 19, 2016
• Start date: October 2015

Study information

• Verified date: September 2016
• 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

This is a phase 2 study to investigate the safety and efficacy of PAC-14028 cream in Atopic Dermatitis patients.

Description:

PAC-14028 Cream (0.1%, 0.3%, 1.0%) or placebo will be treated to Mild to Moderate Atopic Dermatitis patients twice daily for 8 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 192
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 70 Years

Eligibility

Inclusion Criteria:

• Male and female patients aged 19 - 70 years.

• Who was diagnosed with Atopic Dermatitis according to Haniffin and Rajka criteria.

• Whose affected BSA is over 5% and IGA score is 2 (mild) to 3 (moderate).

• Who voluntarily agreed to participate in the study and signed an informed consent form.

Exclusion Criteria:

• Who has skin diseases other than atopic dermatitis or scar in the affected area which can affect the study, determined by the study investigators.

• Who has clinically significant medical history or diseases involving liver, kidney, neurological system, psychical disorder that can affect study results.

• Who has used systemic steroids, antibiotics, immunosuppressants, or received photochemical therapy within 28 days before study drug administration.

• Who has used topical steroids, immunosuppressants or antibiotics to treat atopic dermatitis within 14 days before study drug administration.

• Who has used or is expected to inevitably use prohibited concomitant medications during the study.

• Women who is pregnant /breast-feeding, or who has childbearing potential and does not use available contraceptives.

• Who has dosed other study medications within 30 days before screening.

• Who is determined ineligible for study participation by investigators for any other reasons.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• PAC-14028 cream 0.1%
Topical application
• PAC-14028 cream 0.3%
Topical application
• PAC-14028 cream 1.0%
Topical application
• PAC-14028 cream vehicle
Topical application

Locations

Country	Name	City	State
Korea, Republic of	Chung-ang University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Amorepacific Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success rate of Investigator's Global Assessment (IGA)	percent of patients with IGA score of 0 (clear) or 1 (almost clear)	8 weeks	No
Secondary	Success rate of Investigator's Global Assessment (IGA)	percent of patients with IGA score of 0 (clear) or 1 (almost clear)	1, 3, 6 week(s)	No
Secondary	Change in SCORAD (Severity Score of Atopic Dermatitis)		1, 3, 6, 8 week(s)	No
Secondary	% Change in Eczema Area and Severity Index (EASI)		1, 3, 6, 8 week(s)	No
Secondary	Success rate of Pruritus Severity score		1, 3, 6, 8 week(s)	No