A Phase 3 Trial of OPA-15406 Foam in Children and Infants With Atopic Dermatitis

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age3-14
SponsorOtsuka Pharmaceutical Co., Ltd.

About this trial

To investigate the superiority of 0.3% OPA-15406 foam to the vehicle in children with atopic dermatitis (AD)

Eligibility criteria

Qualifiers

Participants who have been diagnosed with AD based on the Diagnostic Criteria for Atopic Dermatitis (Criteria of the Japanese Dermatological Association)

Participants who have an affected area covering from 5% to 40% of their body surface area (excluding the scalp) at the screening and baseline examinations

Participants with an IGA score of 2 or 3 at the screening and baseline examinations

Disqualifiers

Participants who experienced an acute exacerbation of AD or contact dermatitis within 28 days prior to the baseline examination

Participants who have been treated with OPA-15406 ointment in the past

Trial design

Treatments tested in this trial

  • OPA-15406
  • Vehicle

Treatment groups

198 Participants
are divided into 2 treatment groups