drugset / Trial / NCT00912262
A Study to Investigate the Tolerability and Effects on Epidermal Nerve Fiber Density of Multiple Low-Concentrations of NGX-1998 in Healthy Volunteers
RandomizedSingle-groupSingle-blindTreatment
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.
Timeline
- Start
- 2008-06
- Primary completion
- —
- Completion
- 2008-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Capsaicin | Small molecule | 0.001 % | Topical |
| Comparator | Capsaicin | Small molecule | 0.003 % | Topical |
| Comparator | Capsaicin | Small molecule | 0.1 % | Topical |
| Comparator | Capsaicin | Small molecule | 0.3 % | Topical |
| Comparator | Capsaicin | Small molecule | 1 % | Topical |
| Comparator | Capsaicin | Small molecule | 10 % | Topical |
Indications
No indication recorded.