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

Amorepacific

Status and phase: Completed; Phase 2

Conditions: Atopic Dermatitis

Treatments: Drug: PAC-14028 cream 0.1%; Drug: PAC-14028 cream 1.0%; Drug: PAC-14028 cream vehicle; Drug: PAC-14028 cream 0.3%

Study type: Interventional

Funder types: Industry

Identifiers

NCT02757729

AP-TRPV1-PII_04

Details and patient eligibility

About

This is a phase 2 study to investigate the safety and efficacy of PAC-14028 cream in Atopic Dermatitis patients.

Full description

PAC-14028 Cream (0.1%, 0.3%, 1.0%) or placebo will be treated to Mild to Moderate Atopic Dermatitis patients twice daily for 8 weeks.

Enrollment: 192 patients

Sex: All

Ages: 19 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and female patients aged 19 - 70 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 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 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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192 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 8 weeks

Treatment:

Drug: PAC-14028 cream 0.1%

PAC-14028 cream 0.3%

Experimental group

Description:

PAC-14028 cream 0.3%, Twice daily for 8 weeks

Treatment:

Drug: PAC-14028 cream 0.3%

PAC-14028 cream 1.0%

Experimental group

Description:

PAC-14028 cream 1.0%, Twice daily for 8 weeks

Treatment:

Drug: PAC-14028 cream 1.0%

PAC-14028 cream vehicle

Placebo Comparator group

Description:

PAC-14028 cream vehicle, Twice daily for 8 weeks

Treatment:

Drug: PAC-14028 cream vehicle