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Trial record 75 of 154 for:    Dermatitis, Atopic, 8

A Study to Evaluate the Safety and Efficacy of PAC-14028 Cream in Adults With 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.
 
ClinicalTrials.gov Identifier: NCT02757729
Recruitment Status : Completed
First Posted : May 2, 2016
Last Update Posted : September 20, 2016
Sponsor:
Information provided by (Responsible Party):
Amorepacific Corporation

Brief Summary:
This is a phase 2 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 0.1% Drug: PAC-14028 cream 0.3% Drug: PAC-14028 cream 1.0% Drug: PAC-14028 cream vehicle Phase 2

Detailed Description:
PAC-14028 Cream (0.1%, 0.3%, 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 : 192 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 II Clinical Trial to Evaluate the Safety and Efficacy of PAC-14028 Cream in Mild to Moderate Atopic Dermatitis Patients
Study Start Date : October 2015
Actual Primary Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Experimental: PAC-14028 cream 0.1%
PAC-14028 cream 0.1%, Twice daily for 8 weeks
Drug: PAC-14028 cream 0.1%
Topical application

Experimental: PAC-14028 cream 0.3%
PAC-14028 cream 0.3%, Twice daily for 8 weeks
Drug: PAC-14028 cream 0.3%
Topical application

Experimental: PAC-14028 cream 1.0%
PAC-14028 cream 1.0%, Twice daily for 8 weeks
Drug: PAC-14028 cream 1.0%
Topical application

Placebo Comparator: PAC-14028 cream vehicle
PAC-14028 cream vehicle, 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. Success rate of Investigator's Global Assessment (IGA) [ Time Frame: 1, 3, 6 week(s) ]
    percent of patients with IGA score of 0 (clear) or 1 (almost clear)

  2. Change in SCORAD (Severity Score of Atopic Dermatitis) [ Time Frame: 1, 3, 6, 8 week(s) ]
  3. % Change in Eczema Area and Severity Index (EASI) [ Time Frame: 1, 3, 6, 8 week(s) ]
  4. Success rate of Pruritus Severity score [ Time Frame: 1, 3, 6, 8 week(s) ]


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Ages Eligible for Study:   19 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female patients aged 19 - 70 years.
  • Who was diagnosed with Atopic Dermatitis according to Haniffin and Rajka criteria.
  • Whose affected BSA is over 5% 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 photochemical therapy within 28 days before study drug administration.
  • Who has used topical steroids, immunosuppressants 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 ClinicalTrials.gov identifier (NCT number): NCT02757729


Locations
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Korea, Republic of
Chung-ang University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Amorepacific Corporation
Investigators
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Principal Investigator: Beomjoon Kim, MD, PhD Chung-Ang University Hosptial, Chung-Ang University College of Medicine

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Responsible Party: Amorepacific Corporation
ClinicalTrials.gov Identifier: NCT02757729     History of Changes
Other Study ID Numbers: AP-TRPV1-PII_04
First Posted: May 2, 2016    Key Record Dates
Last Update Posted: September 20, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases