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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Drug: PAC-14028 cream 1.0%
* Drug: PAC-14028 cream vehicle
* Drug: Elidel cream 1%


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PAC-14028 cream 1.0%<br>PAC-14028 cream 1.0%, Twice daily for 4 weeks | Drug: PAC-14028 cream 1.0%<br>* Topical application<br>|
| Placebo Comparator: PAC-14028 cream vehicle<br>PAC-14028 cream vehicle, Twice daily for 4 weeks | Drug: PAC-14028 cream vehicle<br>* Topical application<br>|
| Active Comparator: Elidel cream 1%<br>Elidel cream 1%, Twice daily for 4 weeks | Drug: Elidel cream 1%<br>* Topical application<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SCORing Atopic Dermatitis (SCORAD) index |  | Change from baseline at Day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale (VAS) score |  | Change from baseline at Day 7, 14 and 28 | 
| Success rate to pruritus treatment |  | Change from baseline at Day 7, 14 and 28 | 
| Eczema Area and Severity Index (EASI) score |  | Change from baseline at Day 7, 14 and 28 | 
| Each SCORAD index |  | Change from baseline at Day 7, 14 and 28 | 
| Transepidermal Water Loss (TEWL) level |  | Change from baseline at Day 7, 14 and 28 | 
| Skin Hydration level | Skin hydration was measured using the Corneometer | Change from baseline at Day 7, 14 and 28 |