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Search / Trial NCT05650320

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

Trial Information

Current as of January 14, 2025

Recruiting

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

Lin Ma

Principal Investigator

Beijing Children's Hospital

About Otsuka Beijing Research Institute

Otsuka Beijing Research Institute is a leading clinical research organization dedicated to advancing innovative healthcare solutions through rigorous scientific inquiry and collaboration. As a subsidiary of Otsuka Pharmaceutical Company, the institute focuses on the development of novel therapeutics and medical advancements, leveraging cutting-edge research methodologies and a commitment to improving patient outcomes. With a robust portfolio of clinical trials, Otsuka Beijing Research Institute is at the forefront of translating research into tangible health benefits, fostering partnerships with academic institutions and healthcare professionals to drive progress in the pharmaceutical industry.

Locations

Beijing, Beijing, China

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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