NCT02338648

Safety and Efficacy Study of SUN 131 TDS as Compared to Placebo TDS in Adult Patients With a Chalazion

A Multi-Center, Double-Masked, Randomized, Placebo-Controlled Evaluation of the Safety and Efficacy of SUN 131 Transdermal System (TDS) as Compared to Placebo TDS in Adult Patients With a Chalazion

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Senju USA, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of SUN-131 1.5% TDS as compared with placebo TDS in the treatment of chalazion based on the proportion of subjects that have complete response. Complete response is defined as the absence of any significant clinical signs of a chalazion with possible scaring or skin defects resulting from healing of the chalazion allowed.

Detailed description

Subjects will be randomly assigned to receive one of the following treatments in the affected eyelid: * SUN-131 1.5% TDS (n=30) * Placebo TDS (n=30) At baseline prior to application of the TDS an assessment will be performed on both the subject's eyes including the chalazion site itself. All subjects will return to the site on Days 8±1, 15±2 and 23±2 for evaluations. During the the 23±2 visit, a clinical evaluation will be performed to determine if the chalazion is still present. There will also be follow up on Day 29±3, and on Day 50 visit (study days 47 to 60) to evaluate the safety and durability of the effect of the SUN-131 1.5% TDS. Data review and safety assessments will be conducted by the medical monitor periodically throughout the trial and at the conclusion of the study.

Conditions

• Chalazion

Interventions

Type	Name	Description
DRUG	SUN-131 1.5% TDS	Active transdermal patch
DRUG	Placebo TDS	Placebo transdermal patch for blinding

Timeline

• Start date: 2014-10-01
• Primary completion: 2016-01-01
• Completion: 2016-01-01
• First posted: 2015-01-14
• Last updated: 2017-08-11

Locations

6 sites across 1 country: United States