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

• Status: Completed
• Trial end date: 2015-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amorepacific Corporation

Criteria

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