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

NCT02749383 | Completed Phase 2 DMC

• 1 other identifier: TRPV1-SD_IIT
• Study Type: interventional
• Target: 75
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Seborrheic Dermatitis

Outcome Measures

Primary Outcomes (1)

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

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

  Change from Baseline at Day 14 and Day 28

Secondary Outcomes (3)

• Change in Erythema severity score

  Change from baseline at Day 14 and 28

• Change in Scale severity score

  Baseline, Day 14 and Day 28

• Change in Visual Analogue Scale(VAS) score

  Change from baseline at Day 14 and 28

Study Arms (3)

PAC-14028 cream 0.3%

EXPERIMENTAL

Twice daily for 4 weeks

Drug: PAC-14028 cream 0.3%

PAC-14028 cream 1.0%

EXPERIMENTAL

Twice daily for 4 weeks

Drug: PAC-14028 cream 1.0%

PAC-14028 cream vehicle

PLACEBO COMPARATOR

Twice daily for 4 weeks

Drug: PAC-14028 cream vehicle

Interventions

PAC-14028 cream 0.3% DRUG

Topical application

PAC-14028 cream 0.3%

PAC-14028 cream 1.0% DRUG

Topical application

PAC-14028 cream 1.0%

PAC-14028 cream vehicle DRUG

Topical application

PAC-14028 cream vehicle

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Amorepacific Corporation: lead

MeSH Terms

Conditions

Dermatitis, Seborrheic

Condition Hierarchy (Ancestors)

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

Study Officials

• BeomJoon Kim, Professor

  Department of Dermatology, Chungang University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2015
• First Posted: April 25, 2016
• Study Start: February 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: October 1, 2015
• Last Updated: April 25, 2016

Record last verified: 2016-04