CAPTAIN-AD: Clinical Study of AmorePacific's TRPV1 Antagonist in Atopic Dermatitis

Amorepacific

Status and phase

Completed

Phase 3

Conditions

Atopic Dermatitis

Treatments

Drug: PAC-14028 cream 1.0%

Drug: PAC-14028 cream Vehicle

Study type

Interventional

Funder types

Industry

Identifiers

CAPTAIN-AD-301

Details and patient eligibility

About

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

Full description

PAC-14028 cream 1.0% or placebo will be treated to Mild to Moderate Atopic Dermatitis patients twice daily for 8 weeks.

Enrollment

240 patients

Sex

All

Ages

12 to 70 years old

Volunteers

No Healthy Volunteers

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.