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

A

Amorepacific

Status and phase

Completed
Phase 2
Phase 1

Conditions

Atopic Dermatitis

Treatments

Drug: PAC-14028 Cream 0.1%
Drug: PAC-14028 Cream Vehicle
Drug: PAC-14028 Cream 0.3%
Drug: PAC-14028 Cream 1.0%

Study type

Interventional

Funder types

Industry

Identifiers

NCT02748993
AP-TRPV1_PII-05

Details and patient eligibility

About

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

Enrollment

56 patients

Sex

All

Ages

24 months to 12 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

56 participants in 4 patient groups, including a placebo group

PAC-14028 Cream 0.1%
Experimental group
Description:
PAC-14028 Cream 0.1%, Twice daily for 4 weeks
Treatment:
Drug: PAC-14028 Cream 0.1%
PAC-14028 Cream 0.3%
Experimental group
Description:
PAC-14028 Cream 0.3%, Twice daily for 4 weeks
Treatment:
Drug: PAC-14028 Cream 0.3%
PAC-14028 Cream 1.0%
Experimental group
Description:
PAC-14028 Cream 1.0%, Twice daily for 4 weeks
Treatment:
Drug: PAC-14028 Cream 1.0%
PAC-14028 Cream Vehicle
Placebo Comparator group
Description:
PAC-14028 Cream Vehicle, twice daily for 4 weeks
Treatment:
Drug: PAC-14028 Cream Vehicle

Trial contacts and locations

3

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems