A Study to Evaluate the Safety and Efficacy of PAC-14028 Cream in Atopic Dermatitis
A Randomized, Open-label, Single Center, Investigator-initiated Clinical Study to Evaluate the Safety and Efficacy of PAC-14028 Cream in Subjects With Mild to Moderate Atopic Dermatitis
1 other identifier
interventional
74
0 countries
N/A
Brief Summary
The study is a Phase II, single center, randomized, open-label, placebo-controlled study in male and female subjects, aged ≥ 20 years with mild to moderate atopic dermatitis. All subjects will receive BID topical applications of PAC-14028 cream or vehicle or Elidel cream for up to 4 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jun 2013
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedFirst Submitted
Initial submission to the registry
September 30, 2015
CompletedFirst Posted
Study publicly available on registry
October 21, 2015
CompletedOctober 21, 2015
October 1, 2015
7 months
September 30, 2015
October 20, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
SCORing Atopic Dermatitis (SCORAD) index
Change from baseline at Day 28
Secondary Outcomes (6)
Visual Analogue Scale (VAS) score
Change from baseline at Day 7, 14 and 28
Success rate to pruritus treatment
Change from baseline at Day 7, 14 and 28
Eczema Area and Severity Index (EASI) score
Change from baseline at Day 7, 14 and 28
Each SCORAD index
Change from baseline at Day 7, 14 and 28
Transepidermal Water Loss (TEWL) level
Change from baseline at Day 7, 14 and 28
- +1 more secondary outcomes
Study Arms (3)
PAC-14028 cream 1.0%
EXPERIMENTALPAC-14028 cream 1.0%, Twice daily for 4 weeks
PAC-14028 cream vehicle
PLACEBO COMPARATORPAC-14028 cream vehicle, Twice daily for 4 weeks
Elidel cream 1%
ACTIVE COMPARATORElidel cream 1%, Twice daily for 4 weeks
Interventions
Eligibility Criteria
You may qualify if:
- Male or female patients aged between 20 and 65 years old
- Patients with atopic dermatitis, diagnosed according to Hanifin and Rajka diagnostic criteria
- SCORAD (SCORing Atopic Dermatitis) Score less than 40
You may not qualify if:
- Patients presenting symptoms of systemic infection at screening
- Patients who had been treated with oral steroids, oral antibiotics, systemic phototherapy, or immunosuppressants within the last 1 month prior to the investigational product administration
- Patients who had been treated with topical steroids or antibiotics within the last 2 weeks prior to the investigational product administration
- Pregnant women or breastfeeding women
- Women of childbearing potential or women who are planning a pregnancy during the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
BeomJoon Kim, Professor
Department of Dermatology, Chungang University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 30, 2015
First Posted
October 21, 2015
Study Start
June 1, 2013
Primary Completion
January 1, 2014
Study Completion
August 1, 2015
Last Updated
October 21, 2015
Record last verified: 2015-10