Atopic Dermatitis
Conditions
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.
Interventions
Topical application
Topical application
Topical application
Topical application
Sponsors
Amorepacific Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
24 Months to 12 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success rate of Investigator's Global Assessment (IGA) | 4 weeks | % of patients with IGA score of 0 (clear) or 1 (almost clear) |
| Blood concentrations of PAC-14028 | Day 1, Day 28 | Blood concentrations of PAC-14028 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of IGA (Investigator's Global Assessment) | 1, 2, 4 week(s) | Change of IGA score from baseline |
| Change of SCORAD (Severity Scoring of Atopic Dermatitis) | 1, 2, 4 week(s) | Change of SCORAD from baseline |
| % Change of EASI (Eczema Area and Severity Index) | 1, 2, 4 week(s) | — |
| Patient satisfaction measurement | 4 weeks | — |
Countries
South Korea
Outcome results
None listed