Phase 4
Completed N=31
Anesthetic Effect Duration Assessment
Healthy Volunteers
Source: ClinicalTrials.gov NCT01545765 ↗
Enrolled (actual)
31
Serious AEs
0.0%
Results posted
Sep 2013
Primary outcomePrimary: Duration of Anesthesia(Minutes) — 80; 140; 0; 400 Minutes
Summary
The purpose of this study is to evaluate the duration of anesthetic effect produced , Lidocaine7% + Tetracaine 7% cream when applied with 2 different application times on the face and thigh.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Duration of Anesthesia(Minutes) |
80; 140; 0; 400 | — |
| SECONDARY Adverse Events |
2; 2; 2; 2 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy male of female subjects aged 18 or older with a normal not excessive hairy skin,
Exclusion Criteria
- Female subjects who are pregnant or breast-feeding; or plan to become pregnant,
- Subjects who have a known allergy to one of the components of the test drug lidocaine, tetracaine or other local anesthetics,
- Subjects who are at risk in terms of precautions, warnings, and contra-indication with the study product.
Data sourced from ClinicalTrials.gov (NCT01545765). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.