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NCT Number: NCT02583022

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

The study is a Phase II, single center, randomized, open-label, placebo-controlled study in male and female subjects, aged ≥ 20 years with mild to moderate atopic dermatitis. All subjects will receive BID topical applications of PAC-14028 cream or vehicle or Elidel cream for up to 4 weeks.

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or female patients aged between 20 and 65 years old
  • Patients with atopic dermatitis, diagnosed according to Hanifin and Rajka diagnostic criteria
  • SCORAD (SCORing Atopic Dermatitis) Score less than 40

Exclusion criteria

  • Patients presenting symptoms of systemic infection at screening
  • Patients who had been treated with oral steroids, oral antibiotics, systemic phototherapy, or immunosuppressants within the last 1 month prior to the investigational product administration
  • Patients who had been treated with topical steroids or antibiotics within the last 2 weeks prior to the investigational product administration
  • Pregnant women or breastfeeding women
  • Women of childbearing potential or women who are planning a pregnancy during the study

Treatment and study plan

PAC-14028 cream 1.0%

Drug

Topical application

PAC-14028 cream vehicle

Drug

Topical application

Elidel cream 1%

Drug

Topical application

Primary outcomes

  1. SCORing Atopic Dermatitis (SCORAD) index

    Time frame: Change from baseline at Day 28

Secondary outcomes

  1. Visual Analogue Scale (VAS) score

    Time frame: Change from baseline at Day 7, 14 and 28

  2. Success rate to pruritus treatment

    Time frame: Change from baseline at Day 7, 14 and 28

  3. Eczema Area and Severity Index (EASI) score

    Time frame: Change from baseline at Day 7, 14 and 28

  4. Each SCORAD index

    Time frame: Change from baseline at Day 7, 14 and 28

  5. Transepidermal Water Loss (TEWL) level

    Time frame: Change from baseline at Day 7, 14 and 28

  6. Skin Hydration level

    Time frame: Change from baseline at Day 7, 14 and 28

    Skin hydration was measured using the Corneometer

Sponsors and collaborators

Lead sponsor

Amorepacific Corporation

Industry

Registry information

Official study title

A Randomized, Open-label, Single Center, Investigator-initiated Clinical Study to Evaluate the Safety and Efficacy of PAC-14028 Cream in Subjects With Mild to Moderate Atopic Dermatitis

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Oct 21, 2015
Registry last updated
Oct 21, 2015

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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