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Trial record 1 of 1 for:    NCT02965118
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CAPTAIN-AD: Clinical Study of AmorePacific's TRPV1 Antagonist in Atopic Dermatitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02965118
Recruitment Status : Completed
First Posted : November 16, 2016
Last Update Posted : November 20, 2018
Information provided by (Responsible Party):
Amorepacific Corporation

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

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: PAC-14028 cream 1.0% Drug: PAC-14028 cream Vehicle Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : November 2016
Actual Primary Completion Date : November 2018
Actual Study Completion Date : November 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
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%
topical application

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
topical application

Primary Outcome Measures :
  1. Success rate of Investigator's Global Assessment (IGA) [ Time Frame: 8 weeks ]
    Percent of patients with IGA score of 0 (clear) or 1 (almost clear)

Secondary Outcome Measures :
  1. Change of Investigator's Global Assessment (IGA) score [ Time Frame: 8 weeks ]
    Change of IGA score from baseline

  2. Success rate of ≥2-grade Investigator's Global Assessment (IGA) [ Time Frame: 8 weeks ]
    percent of patients with ≥2 grade reduction of IGA score

  3. Percent of change in Eczema Area and Severity Index (EASI) [ Time Frame: 8 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   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:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02965118

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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Amorepacific Corporation
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Principal Investigator: Kyuhan Kim, MD, PhD Seoul National University Hospital
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Responsible Party: Amorepacific Corporation Identifier: NCT02965118    
Other Study ID Numbers: CAPTAIN-AD-301
First Posted: November 16, 2016    Key Record Dates
Last Update Posted: November 20, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Immune System Diseases