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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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02749383
Enrollment
75
Registered
2016-04-25
Start date
2014-02-28
Completion date
2015-10-31
Last updated
2016-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Seborrheic Dermatitis

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.

Interventions

DRUGPAC-14028 cream 0.3%

Topical application

DRUGPAC-14028 cream 1.0%

Topical application

DRUGPAC-14028 cream vehicle

Topical application

Sponsors

Amorepacific Corporation
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
19 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
Change in Erythema severity scoreChange from baseline at Day 14 and 28—
Change in Scale severity scoreBaseline, Day 14 and Day 28Change from baseline at Day 14 and 28
Change in Visual Analogue Scale(VAS) scoreChange from baseline at Day 14 and 28—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026