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

Phase 3

Completed

• Conditions: Atopic Dermatitis
• Interventions: Drug: PAC-14028 cream Vehicle; Drug: PAC-14028 cream 1.0%

• Registration Number: NCT02965118
• Lead Sponsor: Amorepacific Corporation

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.

Study Timeline

• Study Start: 2016-11
• Study First Submitted: 2016-11-14
• Study First Submitted QC: 2016-11-14
• Study First Posted: 2016-11-16
• Status Verified: 2018-11
• Primary Completion: 2018-11
• Study Completion: 2018-11
• Last Update Submitted: 2018-11-18
• Last Update Posted: 2018-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

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.

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 will be applied to treatment area twice daily for 8 weeks.
PAC-14028 cream 1.0%	PAC-14028 cream 1.0%	PAC-14028 cream 1.0% will be applied to treatment area twice daily for 8 weeks.

Primary Outcome Measures

Name	Time	Method
Success rate of Investigator's Global Assessment (IGA)	8 weeks	Percent of patients with IGA score of 0 (clear) or 1 (almost clear)

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of