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

Atopic Dermatitis Clinical Trial

Official title:

Multi Center, Randomized, Double-blind, Placebo-controlled Parallel-group, Phase III Clinical Trial to Evaluate the Safety and Efficacy of PAC-14028 Cream in Mild to Moderate Atopic Dermatitis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02965118
• Other study ID #: CAPTAIN-AD-301
• Status: Completed
• Phase: Phase 3
• Start date: November 2016
• Est. completion date: November 2018

Study information

• Verified date: November 2018
• Source: Amorepacific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: November 2018
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• PAC-14028 cream 1.0%
topical application
• PAC-14028 cream Vehicle
topical application

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Amorepacific Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success rate of Investigator's Global Assessment (IGA)	Percent of patients with IGA score of 0 (clear) or 1 (almost clear)	8 weeks
Secondary	Change of Investigator's Global Assessment (IGA) score	Change of IGA score from baseline	8 weeks
Secondary	Success rate of =2-grade Investigator's Global Assessment (IGA)	percent of patients with =2 grade reduction of IGA score	8 weeks
Secondary	Percent of change in Eczema Area and Severity Index (EASI)		8 weeks