Comparison Trial of OPA-15406 Ointment in Adult Patients With Atopic DermatitisSyndrome

Last updated: January 21, 2021
Sponsor: Otsuka Pharmaceutical Co., Ltd.
Overall Status: Completed

Phase

3

Condition

Atopic Dermatitis

Hives (Urticaria)

Scalp Disorders

Treatment

N/A

Clinical Study ID

NCT03908970
271-102-00007
  • Ages 15-70
  • All Genders

Study Summary

To demonstrate the superiority of IMP (1% OPA-15406 ointment or vehicle) to the vehicle when administered twice daily for 4 weeks using success rate in Investigator's Global Assessment (IGA) at Week 4 as the primary endpoint in adult patients with AD.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of AD based on the Japanese Dermatological Association's criteria
  • History of AD for at least 3 years
  • Atopic dermatitis affecting more than or equal to 5%, to less than or equal to 40% ofbody surface area (BSA, excluding scalp) at the screening and baseline examinations
  • IGA score of 2 or 3 at the screening and baseline examinations

Exclusion

Exclusion Criteria:

  • Subjects who have an AD or contact dermatitis flare-up defined as a rapidintensification of AD, within 28 days prior to the baseline examination

Study Design

Total Participants: 364
Study Start date:
March 25, 2019
Estimated Completion Date:
December 28, 2019

Connect with a study center

  • Kitago Hifuka Clinic

    Sapporo,
    Japan

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.