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

Phase 2

Completed

• Conditions: Seborrheic Dermatitis
• Interventions: Drug: PAC-14028 cream vehicle; Drug: PAC-14028 cream 1.0%; Drug: PAC-14028 cream 0.3%

• Registration Number: NCT02749383
• Lead Sponsor: Amorepacific Corporation

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02
• Primary Completion: 2014-12
• Study First Submitted: 2015-09-30
• Study Completion: 2015-10
• Status Verified: 2016-04
• Study First Submitted QC: 2016-04-20
• Last Update Submitted: 2016-04-20
• Study First Posted: 2016-04-25
• Last Update Posted: 2016-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PAC-14028 cream vehicle	PAC-14028 cream vehicle	Twice daily for 4 weeks
PAC-14028 cream 1.0%	PAC-14028 cream 1.0%	Twice daily for 4 weeks
PAC-14028 cream 0.3%	PAC-14028 cream 0.3%	Twice daily for 4 weeks

Primary Outcome Measures

Name	Time	Method
Treatment success rate in IGE(Investigator's Global Evaluation)	Change from Baseline at Day 14 and Day 28	Treatment success rate in IGE on 28th day from the baseline

Secondary Outcome Measures

Name	Time	Method
Change in Visual Analogue Scale(VAS) score	Change from baseline at Day 14 and 28
Change in Erythema severity score	Change from baseline at Day 14 and 28
Change in Scale severity score	Baseline, Day 14 and Day 28	Change from baseline at Day 14 and 28