A Study to Investigate the Tolerability and Effects on Epidermal Nerve Fiber Density of Multiple Low-Concentrations of NGX-1998 in Healthy Volunteers
NCT00912262 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36
Last updated 2009-06-03
Summary
The purpose of this single-blinded study in healthy volunteers is to select a Low-Concentration Capsaicin Topical Liquid (LC-CTL) to serve as a control formulation in the further clinical development of Capsaicin Topical Liquid, NGX-1998 (10% w/w). The goal is to identify a low concentration formulation that will not reduce ENFD in healthy normal volunteers when compared to NGX-1998 (10% w/w) but would still produce some local capsaicin-related application site responses (e.g. erythema, heat sensation or pain) when applied.
Conditions
Interventions
- DRUG
-
Capsaicin Topical Liquid
Sponsors & Collaborators
-
NeurogesX
lead INDUSTRY
Principal Investigators
-
Jeff Tobias, MD · NeurogesX
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 40 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2008-06-30
- Completion
- 2008-11-30
Countries
- United States
Study Locations
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