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

A

Amorepacific

Status and phase

Completed
Phase 2

Conditions

Atopic Dermatitis

Treatments

Drug: PAC-14028 cream 0.1%
Drug: PAC-14028 cream 1.0%
Drug: PAC-14028 cream vehicle
Drug: PAC-14028 cream 0.3%

Study type

Interventional

Funder types

Industry

Identifiers

NCT02757729
AP-TRPV1-PII_04

Details and patient eligibility

About

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

Full description

PAC-14028 Cream (0.1%, 0.3%, 1.0%) or placebo will be treated to Mild to Moderate Atopic Dermatitis patients twice daily for 8 weeks.

Enrollment

192 patients

Sex

All

Ages

19 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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.

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, 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

192 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 8 weeks
Treatment:
Drug: PAC-14028 cream 0.1%
PAC-14028 cream 0.3%
Experimental group
Description:
PAC-14028 cream 0.3%, Twice daily for 8 weeks
Treatment:
Drug: PAC-14028 cream 0.3%
PAC-14028 cream 1.0%
Experimental group
Description:
PAC-14028 cream 1.0%, Twice daily for 8 weeks
Treatment:
Drug: PAC-14028 cream 1.0%
PAC-14028 cream vehicle
Placebo Comparator group
Description:
PAC-14028 cream vehicle, Twice daily for 8 weeks
Treatment:
Drug: PAC-14028 cream vehicle

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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