CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 120 enrolled
Drug / intervention
Topical steroid (Dexamethasone) +1 moredrug
Likely dose
Topical steroid (Dexamethasone) 1 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01737931
NCT01737931Phase 1Completed
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An Open-Label Trial to Explore Symptomatic Therapy for Application Site Reaction to SPM962 in Healthy Subject

Otsuka Pharmaceutical Co., Ltd.·interventional·Posted Nov 30, 2012·Updated Apr 29, 2014

In Brief

A Phase 1 clinical trial evaluating Topical steroid (Dexamethasone) and Topical antihistamine (Diphenhydramine) for Healthy. Completed, enrolled 120 participants across 2 sites.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesSouth Korea
Collaborators--

Timeline

Phase 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedNov 30, 2012
Enrollment StartAug 1, 2012
Primary CompletionOct 1, 2012
Study CompletionNov 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 13.6 years ago

Interventions

Topical steroid (Dexamethasone)drug

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

Topical antihistamine (Diphenhydramine)drug

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