To Demonstrate the Superiority of IMP (0.3% and 1% OPA-15406 Ointment) Versus the Vehicle in Pediatric Patients With AD

Launched by OTSUKA BEIJING RESEARCH INSTITUTE · Dec 6, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new ointment called OPA-15406 to see if it is more effective than a placebo (a cream without active ingredients) in treating atopic dermatitis (AD), a common skin condition that causes itchy and inflamed skin in children. The trial is for children aged 2 to 14 years who have been diagnosed with AD that covers between 5% and 40% of their body surface area, excluding the scalp. The trial will compare two different strengths of the ointment (0.3% and 1%) against the placebo to determine which is better at helping manage the symptoms of AD.

Participants in the trial can expect to receive either the ointment or the placebo for a four-week period. The study is currently recruiting participants, and both boys and girls are welcome to join. It's important to note that children who have had a rapid worsening of their skin condition in the 28 days before the trial may not be eligible to participate. This trial is significant because it aims to find a potentially more effective treatment option for children suffering from atopic dermatitis.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Sex: Either male or female. Age: 2 to 14 years, inclusive (at time of obtaining informed consent) (only for 4 weeks double blind treatment).
• • 2. Diagnosis of AD based on the criteria of Hanifin and Rajka (see Appendix 1).
• • 3. Atopic dermatitis affecting ≥5% to ≤40% of BSA (excluding scalp) at the screening and baseline visit(only for 4 weeks double blind treatment).
• Exclusion Criteria:
• • 1. Subjects who defined as AD or contact dermatitis rapid deterioration, within 28 days prior to the baseline visit.

Trial Officials