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CompletedNCT02749383Updated Apr 25, 2016

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

A Phase 2 interventional study of PAC-14028 cream 0.3% and PAC-14028 cream 1.0% in Seborrheic Dermatitis, sponsored by Amorepacific Corporation. Completed. Open to participants aged 19 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-04-25.

Sponsored by Amorepacific Corporation · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
75
Allocation
Randomized
Ages
19 Years to 65 Years
Sex
All
01

Study 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.

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Conditions studied

  • Seborrheic Dermatitis
03

In context

Dermatitis

1,435 studies on the registry are indexed under Dermatitis; 131 are open to participants now.

This study's enrollment of 75 is above the median of 64 across 1,131 interventional studies indexed under Dermatitis.

Browse Dermatitis studies →

Lead sponsor

Amorepacific Corporation is the lead sponsor of 22 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
75 participants (actual)

Study arms

  • Experimental
    PAC-14028 cream 0.3%

    Twice daily for 4 weeks

    Drug: PAC-14028 cream 0.3%

  • Experimental
    PAC-14028 cream 1.0%

    Twice daily for 4 weeks

    Drug: PAC-14028 cream 1.0%

  • Placebo comparator
    PAC-14028 cream vehicle

    Twice daily for 4 weeks

    Drug: PAC-14028 cream vehicle

Interventions

  • DrugPAC-14028 cream 0.3%

    Topical application

  • DrugPAC-14028 cream 1.0%

    Topical application

  • DrugPAC-14028 cream vehicle

    Topical application

06

What researchers measure

Primary outcomes

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

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

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

Secondary outcomes

  1. Change in Erythema severity score

    Time frame: Change from baseline at Day 14 and 28

  2. Change in Scale severity score

    Change from baseline at Day 14 and 28

    Time frame: Baseline, Day 14 and Day 28

  3. Change in Visual Analogue Scale(VAS) score

    Time frame: Change from baseline at Day 14 and 28

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 25, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02749383
Lead sponsor
Amorepacific Corporation
Responsible party
Sponsor
First posted
Apr 25, 2016
Start date
Feb 2014
Primary completion
Dec 2014
Completion
Oct 2015
Last update
Apr 25, 2016

Study contacts

BeomJoon Kim, Professor
principal investigator · Department of Dermatology, Chungang University Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.

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Discussion

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