Atopic Dermatitis
Conditions
Brief summary
This is a phase III study to investigate the safety and efficacy of PAC-14028 cream in Atopic Dermatitis patients.
Detailed description
PAC-14028 cream 1.0% or placebo will be treated to Mild to Moderate Atopic Dermatitis patients twice daily for 8 weeks.
Interventions
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
12 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Male and female patients aged 12 - 70 years. * Who was diagnosed with Atopic Dermatitis according to Haniffin and Rajka criteria. * Whose affected TBSA is over 5% and below 30%, 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 phototherapy within 28 days before study drug administration. * Who has used topical steroids, topical calcineurin inhibitors 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) | 8 weeks | Percent of patients with IGA score of 0 (clear) or 1 (almost clear) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of Investigator's Global Assessment (IGA) score | 8 weeks | Change of IGA score from baseline |
| Success rate of ≥2-grade Investigator's Global Assessment (IGA) | 8 weeks | percent of patients with ≥2 grade reduction of IGA score |
| Percent of change in Eczema Area and Severity Index (EASI) | 8 weeks | — |
Countries
South Korea
Outcome results
None listed