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CompletedNCT02965118Updated Nov 20, 2018

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

A Phase 3 interventional study of PAC-14028 cream 1.0% and PAC-14028 cream Vehicle in Atopic Dermatitis, sponsored by Amorepacific Corporation. Completed at 1 site in Korea, Republic of. Open to participants aged 12 Years to 70 Years. Per ClinicalTrials.gov, last updated 2018-11-20.

Sponsored by Amorepacific Corporation · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
240
Allocation
Randomized
Ages
12 Years to 70 Years
Sex
All
01

Study summary

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

Read the detailed description

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

02

Conditions studied

  • Atopic Dermatitis
03

In context

Dermatitis, Atopic

1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.

This study's enrollment of 240 is above the median of 83 across 1,125 interventional studies indexed under Dermatitis, Atopic.

Browse Dermatitis, Atopic studies →

Lead sponsor

Amorepacific Corporation is the lead sponsor of 22 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
240 participants (actual)

Study arms

  • Experimental
    PAC-14028 cream 1.0%

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

    Drug: PAC-14028 cream 1.0%

  • Placebo comparator
    PAC-14028 cream Vehicle

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

    Drug: PAC-14028 cream Vehicle

Interventions

  • DrugPAC-14028 cream 1.0%

    topical application

  • DrugPAC-14028 cream Vehicle

    topical application

06

What researchers measure

Primary outcomes

  1. Success rate of Investigator's Global Assessment (IGA)

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

    Time frame: 8 weeks

Secondary outcomes

  1. Change of Investigator's Global Assessment (IGA) score

    Change of IGA score from baseline

    Time frame: 8 weeks

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

    percent of patients with ≥2 grade reduction of IGA score

    Time frame: 8 weeks

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

    Time frame: 8 weeks

07

Study locations

1 site
  • Seoul National University Hospital
    Seoul, Korea, Republic of
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 20, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02965118
Lead sponsor
Amorepacific Corporation
Responsible party
Sponsor
First posted
Nov 16, 2016
Start date
Nov 2016
Primary completion
Nov 2018
Completion
Nov 2018
Last update
Nov 20, 2018

Study contacts

Kyuhan Kim, MD, PhD
principal investigator · Seoul National University Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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Amorepacific Corporation

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