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

Amorepacific

Status and phase: Completed; Phase 2; Phase 1

Conditions: Atopic Dermatitis

Treatments: Drug: PAC-14028 Cream 0.1%; Drug: PAC-14028 Cream Vehicle; Drug: PAC-14028 Cream 0.3%; Drug: PAC-14028 Cream 1.0%

Study type: Interventional

Funder types: Industry

Identifiers

NCT02748993

AP-TRPV1_PII-05

Details and patient eligibility

About

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

Enrollment: 56 patients

Sex: All

Ages: 24 months to 12 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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56 participants in 4 patient groups, including a placebo group

PAC-14028 Cream 0.1%

Experimental group

Description:

PAC-14028 Cream 0.1%, Twice daily for 4 weeks

Treatment:

Drug: PAC-14028 Cream 0.1%

PAC-14028 Cream 0.3%

Experimental group

Description:

PAC-14028 Cream 0.3%, Twice daily for 4 weeks

Treatment:

Drug: PAC-14028 Cream 0.3%

PAC-14028 Cream 1.0%

Experimental group

Description:

PAC-14028 Cream 1.0%, Twice daily for 4 weeks

Treatment:

Drug: PAC-14028 Cream 1.0%

PAC-14028 Cream Vehicle

Placebo Comparator group

Description:

PAC-14028 Cream Vehicle, twice daily for 4 weeks

Treatment:

Drug: PAC-14028 Cream Vehicle