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

A

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

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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