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

Atopic Dermatitis Clinical Trial

Official title:

A Randomized, Double-blind, Placebo-Controlled, Parallel Study to Investigate the Safety, Tolerability, Systemic Exposure and Efficacy of PAC-14028 in Children With Mild to Moderate Pediatric Atopic Dermatitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02748993
• Other study ID #: AP-TRPV1_PII-05
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: March 2016
• Est. completion date: October 2018

Study information

• Verified date: November 2018
• Source: Amorepacific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a phase 1 and 2 study to assess the safety and efficacy of PAC-14028 cream in children with atopic dermatitis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: October 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 24 Months to 12 Years

Eligibility

Inclusion Criteria:

• Male and female patients aged 24 months - 12 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 has applied stable amount of emollients daily before baseline visit

• 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, psychial 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.

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
Korea, Republic of	Konkuk University Hospital	Seoul
Korea, Republic of	Seoul National 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)	% of patients with IGA score of 0 (clear) or 1 (almost clear)	4 weeks
Primary	Blood concentrations of PAC-14028	Blood concentrations of PAC-14028	Day 1, Day 28
Secondary	Change of IGA (Investigator's Global Assessment)	Change of IGA score from baseline	1, 2, 4 week(s)
Secondary	Change of SCORAD (Severity Scoring of Atopic Dermatitis)	Change of SCORAD from baseline	1, 2, 4 week(s)
Secondary	% Change of EASI (Eczema Area and Severity Index)		1, 2, 4 week(s)
Secondary	Patient satisfaction measurement		4 weeks