NCT01737931

A Trial to Explore Symptomatic Therapy for Application Site Reaction to SPM962 in Healthy Subject

An Open-Label Trial to Explore Symptomatic Therapy for Application Site Reaction to SPM962 in Healthy Subject

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Otsuka Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

Summary

To investigate the efficacy of symptomatic therapy with topical steroids and antihistamines for application site reaction (ASR) after administration of SPM 962 in healthy subjects

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Topical steroid (Dexamethasone)	for SPM 962: 1 mg/24h patch for 48 hours as Acceleration period, then 2 mg/24h patch to the other site for 24 hours as Dose-escalation period, for steroid: twice daily administration of Dexamethasone (1 mg/g cream) to the application sites after the patch removal
DRUG	Topical antihistamine (Diphenhydramine)	for SPM 962: 1 mg/24h patch for 48 hours as Acceleration period, then 2 mg/24h patch to the other site for 24 hours as Dose-escalation period, for antihistamine: twice daily administration of Diphenhydramine (10 mg/g cream) to the application sites after the patch removal

Timeline

• Start date: 2012-08-01
• Primary completion: 2012-10-01
• Completion: 2012-11-01
• First posted: 2012-11-30
• Last updated: 2014-04-29
• Results posted: 2014-04-29

Locations

2 sites across 1 country: South Korea