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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2015-10-31

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.

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Detailed Description

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Conditions

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Seborrheic Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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PAC-14028 cream 0.3%

Twice daily for 4 weeks

Group Type EXPERIMENTAL

PAC-14028 cream 0.3%

Intervention Type DRUG

Topical application

PAC-14028 cream 1.0%

Twice daily for 4 weeks

Group Type EXPERIMENTAL

PAC-14028 cream 1.0%

Intervention Type DRUG

Topical application

PAC-14028 cream vehicle

Twice daily for 4 weeks

Group Type PLACEBO_COMPARATOR

PAC-14028 cream vehicle

Intervention Type DRUG

Topical application

Interventions

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PAC-14028 cream 0.3%

Topical application

Intervention Type DRUG

PAC-14028 cream 1.0%

Topical application

Intervention Type DRUG

PAC-14028 cream vehicle

Topical application

Intervention Type DRUG

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

Minimum Eligible Age

19 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No