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NCT Number: NCT02749383

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

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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Key information

Conditions

Seborrheic Dermatitis Dermatitis Dermatitis, Seborrheic Sebaceous Gland Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PAC-14028 cream 0.3%

Drug

Topical application

PAC-14028 cream 1.0%

Drug

Topical application

PAC-14028 cream vehicle

Drug

Topical application

Primary outcomes

  1. Treatment success rate in IGE(Investigator's Global Evaluation)

    Time frame: Change from Baseline at Day 14 and Day 28

    Treatment success rate in IGE on 28th day from the baseline

Secondary outcomes

  1. Change in Erythema severity score

    Time frame: Change from baseline at Day 14 and 28

  2. Change in Scale severity score

    Time frame: Baseline, Day 14 and Day 28

    Change from baseline at Day 14 and 28

  3. Change in Visual Analogue Scale(VAS) score

    Time frame: Change from baseline at Day 14 and 28

Sponsors and collaborators

Lead sponsor

Amorepacific Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Apr 25, 2016
Registry last updated
Apr 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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