NCT02757729

Brief Summary

This is a phase 2 study to investigate the safety and efficacy of PAC-14028 cream in Atopic Dermatitis patients.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
192

participants targeted

Target at P75+ for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 20, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 2, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Last Updated

September 20, 2016

Status Verified

September 1, 2016

Enrollment Period

10 months

First QC Date

April 20, 2016

Last Update Submit

September 19, 2016

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

  • Success rate of Investigator's Global Assessment (IGA)

    percent of patients with IGA score of 0 (clear) or 1 (almost clear)

    8 weeks

Secondary Outcomes (4)

  • Success rate of Investigator's Global Assessment (IGA)

    1, 3, 6 week(s)

  • Change in SCORAD (Severity Score of Atopic Dermatitis)

    1, 3, 6, 8 week(s)

  • % Change in Eczema Area and Severity Index (EASI)

    1, 3, 6, 8 week(s)

  • Success rate of Pruritus Severity score

    1, 3, 6, 8 week(s)

Study Arms (4)

PAC-14028 cream 0.1%

EXPERIMENTAL

PAC-14028 cream 0.1%, Twice daily for 8 weeks

Drug: PAC-14028 cream 0.1%

PAC-14028 cream 0.3%

EXPERIMENTAL

PAC-14028 cream 0.3%, Twice daily for 8 weeks

Drug: PAC-14028 cream 0.3%

PAC-14028 cream 1.0%

EXPERIMENTAL

PAC-14028 cream 1.0%, Twice daily for 8 weeks

Drug: PAC-14028 cream 1.0%

PAC-14028 cream vehicle

PLACEBO COMPARATOR

PAC-14028 cream vehicle, Twice daily for 8 weeks

Drug: PAC-14028 cream vehicle

Interventions

PAC-14028 cream 0.1%DRUG

Topical application

PAC-14028 cream 0.1%
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 vehicleDRUG

Topical application

PAC-14028 cream vehicle

Eligibility Criteria

Age19 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female patients aged 19 - 70 years.
  • Who was diagnosed with Atopic Dermatitis according to Haniffin and Rajka criteria.
  • Whose affected BSA is over 5% and IGA score is 2 (mild) to 3 (moderate).
  • Who voluntarily agreed to participate in the study and signed an informed consent form.

You may not qualify if:

  • Who has skin diseases other than atopic dermatitis or scar in the affected area which can affect the study, determined by the study investigators.
  • Who has clinically significant medical history or diseases involving liver, kidney, neurological system, psychical disorder that can affect study results.
  • Who has used systemic steroids, antibiotics, immunosuppressants, or received photochemical therapy within 28 days before study drug administration.
  • Who has used topical steroids, immunosuppressants or antibiotics to treat atopic dermatitis within 14 days before study drug administration.
  • Who has used or is expected to inevitably use prohibited concomitant medications during the study.
  • Women who is pregnant /breast-feeding, or who has childbearing potential and does not use available contraceptives.
  • Who has dosed other study medications within 30 days before screening.
  • Who is determined ineligible for study participation by investigators for any other reasons.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chung-ang University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Beomjoon Kim, MD, PhD

    Chung-Ang University Hosptial, Chung-Ang University College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2016

First Posted

May 2, 2016

Study Start

October 1, 2015

Primary Completion

August 1, 2016

Last Updated

September 20, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)