A Study to Evaluate the Safety and Efficacy of PAC-14028 Cream in Pediatric Atopic Dermatitis
Phase 1
Completed
- Conditions
- Atopic Dermatitis
- Interventions
- Registration Number
- NCT02748993
- Lead Sponsor
- Amorepacific Corporation
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 56
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PAC-14028 Cream Vehicle PAC-14028 Cream Vehicle PAC-14028 Cream Vehicle, twice daily for 4 weeks PAC-14028 Cream 0.3% PAC-14028 Cream 0.3% PAC-14028 Cream 0.3%, Twice daily for 4 weeks PAC-14028 Cream 1.0% PAC-14028 Cream 1.0% PAC-14028 Cream 1.0%, Twice daily for 4 weeks PAC-14028 Cream 0.1% PAC-14028 Cream 0.1% PAC-14028 Cream 0.1%, Twice daily for 4 weeks
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Patient satisfaction measurement 4 weeks 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)
Trial Locations
- Locations (3)
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Konkuk University Hospital
🇰🇷Seoul, Korea, Republic of
Chung-ang University Hospital
🇰🇷Seoul, Korea, Republic of