Clinical trial NCT02748993: A Study to Evaluate the Safety and Efficacy of PAC-14028 Cream in Pediatric Atopic Dermatitis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Atopic Dermatitis
Lead sponsor: Amorepacific Corporation
Sponsor class: INDUSTRY
First posted: 2016-04-22
Enrollment: 56
Sex: ALL
Minimum age (years): 24
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Success rate of Investigator's Global Assessment (IGA)
timeFrame: 4 weeks
measure: Blood concentrations of PAC-14028
timeFrame: Day 1, Day 28
Secondary outcomes:
measure: Change of IGA (Investigator's Global Assessment)
timeFrame: 1, 2, 4 week(s)
measure: Change of SCORAD (Severity Scoring of Atopic Dermatitis)
timeFrame: 1, 2, 4 week(s)
measure: % Change of EASI (Eczema Area and Severity Index)
timeFrame: 1, 2, 4 week(s)
measure: Patient satisfaction measurement
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Chung-ang University Hospital
city: Seoul
country: Korea, Republic of
facility: Konkuk University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Kyuhan Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: