NCT01737931 - A Trial to Explore Symptomatic Therapy for Application Site Reaction to SPM962 in Healthy Subject | Biotech Hunter

Enrollment

120

Participants

Timeline

Start Date

August 31, 2012

Primary Completion Date

October 31, 2012

Study Completion Date

November 30, 2012

Conditions

Healthy

Interventions

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

Trial Locations (2)

Unknown

Seoul National University Bundang Hospital, Kyeonggi-do

Seoul National University Hospital, Seoul