NCT03622463

A Trial of Antroquinonol in Patients With Atopic Dermatitis

A Randomized, Double-Blind, Placebo-controlled Trial of Antroquinonol in Patients With Atopic Dermatitis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Golden Biotechnology Corporation · Industry
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-centers, phase IIa, double blind, randomized, placebo-controlled trial of Antroquinonol in patients with atopic dermatitis.Duration of treatment is 12 week in total. Study visits will occur every 4 weeks. AEs/SAEs, changes to concomitant medications will be noted, vital signs will be taken, and efficacy evaluations will be performed as well. The last estimation of variable scores will occur for all subjects.

Detailed description

This is a multi-centers, phase IIa, double blind, randomized, placebo-controlled trial of Antroquinonol in patients with atopic dermatitis.Duration of treatment is 12 week in total. Study visits will occur every 4 weeks. During these visits study drug will be administered at the site, new AEs/SAEs as well as follow-up for AEs and SAEs that have not been resolved will be recorded, changes to concomitant medications will be noted, vital signs will be taken, and efficacy evaluations will be performed as well. The study includes collection of cytokines samples. The end-of-treatment visit and the last estimation of variable scores will occur at week 13 (visit 5) for all subjects. The final visit will be at week 15 (visit 6). Subjects will be encouraged to complete all planned visits regardless of their adherence to study drug administration.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	Antroquinonol	Antroquinonol will be provided as a capsule-shaped which contain 50 mg Antroquinonol.
OTHER	Placebo	The matching placebo will be packaged as Antroquinonol with appearance identical in all aspects

Timeline

• Start date: 2018-07-17
• Primary completion: 2019-07-09
• Completion: 2019-07-09
• First posted: 2018-08-09
• Last updated: 2019-08-29

Locations

1 site across 1 country: Taiwan