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

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

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.

Study Overview

• Status: Completed
• Conditions: Seborrheic Dermatitis
• Intervention / Treatment: Drug: PAC-14028 cream 0.3%; Drug: PAC-14028 cream 1.0%; Drug: PAC-14028 cream vehicle

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: PAC-14028 cream 0.3%; Twice daily for 4 weeks	Drug: PAC-14028 cream 0.3%; Topical application
EXPERIMENTAL: PAC-14028 cream 1.0%; Twice daily for 4 weeks	Drug: PAC-14028 cream 1.0%; Topical application
PLACEBO_COMPARATOR: PAC-14028 cream vehicle; Twice daily for 4 weeks	Drug: PAC-14028 cream vehicle; Topical application

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Amorepacific Corporation

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (ACTUAL): December 1, 2014
• Study Completion (ACTUAL): October 1, 2015

Study Registration Dates

• First Submitted: September 30, 2015
• First Submitted That Met QC Criteria: April 20, 2016
• First Posted (ESTIMATE): April 25, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): April 25, 2016
• Last Update Submitted That Met QC Criteria: April 20, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Skin Diseases, Eczematous; Sebaceous Gland Diseases; Dermatitis; Dermatitis, Seborrheic
• Other Study ID Numbers: TRPV1-SD_IIT