Phase 4
N=31
Anesthetic Effect Duration Assessment
Healthy Volunteers
Bottom Line
View on ClinicalTrials.gov: NCT01545765 ↗Enrolled (actual)
31
Serious AEs
0.0%
Results posted
Sep 2013
Primary outcome: Primary: Duration of Anesthesia(Minutes) — 80; 140; 0; 400 Minutes
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Lidocaine 7% + Tetracaine 7% cream (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Galderma R&D
- Primary completion
- May 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Duration of Anesthesia(Minutes) |
80; 140; 0; 400 | — |
| SECONDARY Adverse Events |
2; 2; 2; 2 | — |
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.
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.