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

Study Overview
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Brief Summary
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This study is a Phase II, single center, randomized, double-blind, placebo-controlled study in male and female subjects, aged ≥ 19 years with mild to moderate seborrheic dermatitis of the face. All subjects will receive BID topical applications of PAC-14028 cream or vehicle for up to 4 weeks.

Official Title
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A Randomized, Double-blind, Single Center, Investigator-initiated Clinical Study to Evaluate the Safety and Efficacy of PAC-14028 Cream in Subjects With Mild to Moderate Seborrheic Dermatitis of the Face

Conditions
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Seborrheic Dermatitis

Intervention / Treatment
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* Drug: PAC-14028 cream 0.3%
* Drug: PAC-14028 cream 1.0%
* Drug: PAC-14028 cream vehicle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female patients aged between 19 and 65 years old Clinical diagnosis of seborrheic dermatitis in the facial area with Erythema severity ≥ 2 and Scaling severity ≥ 2 IGE (Investigator's Global Evaluation) Score 2 or 3 Exclusion Criteria: Patients with psoriasis, atopic dermatitis, facial acne, rosacea or perioral dermatitis Patients who have been infected with bacteria, fungi, virus and animal infectious disease on the facial area Patients who were administered topical antifungal agents, steroids, retinoids, or calcineurin suppressants for the treatment of seborrheic dermatitis within the last 2 weeks Patients who were administered systemic antifungal agents, steroids, retinoids, or immunosuppressants for the treatment of seborrheic dermatitis within the last 4 weeks Patients who were administered local antibiotics for the treatment of seborrheic dermatitis within the last 4 weeks Pregnant women, breastfeeding women or women of childbearing potential or women who are planning a pregnancy during the study

Ages Eligible for Study
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Minimum Age: 19 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PAC-14028 cream 0.3%<br>Twice daily for 4 weeks | Drug: PAC-14028 cream 0.3%<br>* Topical application<br>|
| Experimental: PAC-14028 cream 1.0%<br>Twice daily for 4 weeks | Drug: PAC-14028 cream 1.0%<br>* Topical application<br>|
| Placebo Comparator: PAC-14028 cream vehicle<br>Twice daily for 4 weeks | Drug: PAC-14028 cream vehicle<br>* Topical application<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment success rate in IGE(Investigator's Global Evaluation) | Treatment success rate in IGE on 28th day from the baseline | Change from Baseline at Day 14 and Day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Erythema severity score |  | Change from baseline at Day 14 and 28 | 
| Change in Scale severity score | Change from baseline at Day 14 and 28 | Baseline, Day 14 and Day 28 | 
| Change in Visual Analogue Scale(VAS) score |  | Change from baseline at Day 14 and 28 |