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Completed

NCT Number: NCT02757729

A Study to Evaluate the Safety and Efficacy of PAC-14028 Cream in Adults With Atopic Dermatitis

This is a phase 2 study to investigate the safety and efficacy of PAC-14028 cream in Atopic Dermatitis patients.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PAC-14028 cream 0.1%

Drug

Topical application

PAC-14028 cream 0.3%

Drug

Topical application

PAC-14028 cream 1.0%

Drug

Topical application

PAC-14028 cream vehicle

Drug

Topical application

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Amorepacific Corporation

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2016
First posted
May 2, 2016
Registry last updated
Sep 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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