NCT02748993

Brief Summary

This is a phase 1 and 2 study to assess the safety and efficacy of PAC-14028 cream in children with atopic dermatitis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2016

Typical duration for phase_1

Geographic Reach
1 country

3 active sites

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

March 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 20, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 22, 2016

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

November 20, 2018

Status Verified

November 1, 2018

Enrollment Period

2.5 years

First QC Date

April 20, 2016

Last Update Submit

November 18, 2018

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (2)

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

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

    4 weeks

  • Blood concentrations of PAC-14028

    Blood concentrations of PAC-14028

    Day 1, Day 28

Secondary Outcomes (4)

  • Change of IGA (Investigator's Global Assessment)

    1, 2, 4 week(s)

  • Change of SCORAD (Severity Scoring of Atopic Dermatitis)

    1, 2, 4 week(s)

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

    1, 2, 4 week(s)

  • Patient satisfaction measurement

    4 weeks

Study Arms (4)

PAC-14028 Cream 0.1%

EXPERIMENTAL

PAC-14028 Cream 0.1%, Twice daily for 4 weeks

Drug: PAC-14028 Cream 0.1%

PAC-14028 Cream 0.3%

EXPERIMENTAL

PAC-14028 Cream 0.3%, Twice daily for 4 weeks

Drug: PAC-14028 Cream 0.3%

PAC-14028 Cream 1.0%

EXPERIMENTAL

PAC-14028 Cream 1.0%, Twice daily for 4 weeks

Drug: PAC-14028 Cream 1.0%

PAC-14028 Cream Vehicle

PLACEBO COMPARATOR

PAC-14028 Cream Vehicle, twice daily for 4 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

Age24 Months - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Male and female patients aged 24 months - 12 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 has applied stable amount of emollients daily before baseline visit
  • 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, psychial 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 (3)

Chung-ang University Hospital

Seoul, South Korea

Location

Konkuk University Hospital

Seoul, South Korea

Location

Seoul National 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

  • Kyuhan Kim, MD, PhD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
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

April 22, 2016

Study Start

March 1, 2016

Primary Completion

September 1, 2018

Study Completion

October 1, 2018

Last Updated

November 20, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

KR(3)