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Completed

NCT Number: NCT02748993

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

This is a phase 1 and 2 study to assess the safety and efficacy of PAC-14028 cream in children with atopic dermatitis.

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Key information

Age range

24 month–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Chung-ang University Hospital, Seoul, South Korea

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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 24 months - 12 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 has applied stable amount of emollients daily before baseline visit
  • 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, psychial 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: 4 weeks

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

  2. Blood concentrations of PAC-14028

    Time frame: Day 1, Day 28

    Blood concentrations of PAC-14028

Secondary outcomes

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

    Time frame: 1, 2, 4 week(s)

    Change of IGA score from baseline

  2. Change of SCORAD (Severity Scoring of Atopic Dermatitis)

    Time frame: 1, 2, 4 week(s)

    Change of SCORAD from baseline

  3. % Change of EASI (Eczema Area and Severity Index)

    Time frame: 1, 2, 4 week(s)

  4. Patient satisfaction measurement

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Amorepacific Corporation

Industry

Registry information

Official study title

A Randomized, Double-blind, Placebo-Controlled, Parallel Study to Investigate the Safety, Tolerability, Systemic Exposure and Efficacy of PAC-14028 in Children With Mild to Moderate Pediatric Atopic Dermatitis

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Apr 22, 2016
Registry last updated
Nov 20, 2018

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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