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

Last updated: November 18, 2018
Sponsor: Amorepacific Corporation
Overall Status: Completed

Phase

3

Condition

Atopic Dermatitis

Allergy

Dermatitis, Atopic

Treatment

N/A

Clinical Study ID

NCT02965118
CAPTAIN-AD-301
  • Ages 12-70
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 consentform.

Exclusion

Exclusion Criteria:

  • Who has skin diseases other than atopic dermatitis or scar in the affected area whichcan 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 receivedphototherapy within 28 days before study drug administration.

  • Who has used topical steroids, topical calcineurin inhibitors or antibiotics to treatatopic dermatitis within 14 days before study drug administration.

  • Who has used or is expected to inevitably use prohibited concomitant medicationsduring the study.

  • Women who is pregnant /breast-feeding, or who has childbearing potential and does notuse available contraceptives.

  • Who has dosed other study medications within 30 days before screening.

  • Who is determined ineligible for study participation by investigators for any otherreasons.

Study Design

Total Participants: 240
Study Start date:
November 01, 2016
Estimated Completion Date:
November 30, 2018

Study Description

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

Connect with a study center

  • Seoul National University Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

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