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

Amorepacific

Status and phase: Completed; Phase 2

Conditions: Seborrheic Dermatitis

Treatments: Drug: PAC-14028 cream 0.3%; Drug: PAC-14028 cream 1.0%; Drug: PAC-14028 cream vehicle

Study type: Interventional

Funder types: Industry

Identifiers

NCT02749383

TRPV1-SD_IIT

Details and patient eligibility

About

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.

Enrollment: 75 patients

Sex: All

Ages: 19 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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75 participants in 3 patient groups, including a placebo group

PAC-14028 cream 0.3%

Experimental group

Description:

Twice daily for 4 weeks

Treatment:

Drug: PAC-14028 cream 0.3%

PAC-14028 cream 1.0%

Experimental group

Description:

Twice daily for 4 weeks

Treatment:

Drug: PAC-14028 cream 1.0%

PAC-14028 cream vehicle

Placebo Comparator group

Description:

Twice daily for 4 weeks

Treatment:

Drug: PAC-14028 cream vehicle