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

NCT02965118 | Completed Phase 3 DMC

• 1 other identifier: CAPTAIN-AD-301
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• Success rate of Investigator's Global Assessment (IGA)

  Percent of patients with IGA score of 0 (clear) or 1 (almost clear)

  8 weeks

Secondary Outcomes (3)

• Change of Investigator's Global Assessment (IGA) score

  8 weeks

• Success rate of ≥2-grade Investigator's Global Assessment (IGA)

  8 weeks

• Percent of change in Eczema Area and Severity Index (EASI)

  8 weeks

Study Arms (2)

PAC-14028 cream 1.0%

EXPERIMENTAL

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

Drug: PAC-14028 cream 1.0%

PAC-14028 cream Vehicle

PLACEBO COMPARATOR

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

Drug: PAC-14028 cream Vehicle

Interventions

PAC-14028 cream 1.0% DRUG

topical application

PAC-14028 cream 1.0%

PAC-14028 cream Vehicle DRUG

topical application

PAC-14028 cream Vehicle

Eligibility Criteria

• Age: 12 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Amorepacific Corporation: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Kyuhan Kim, MD, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2016
• First Posted: November 16, 2016
• Study Start: November 1, 2016
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2018
• Last Updated: November 20, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)