Anesthetic Effect Duration Assessment
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy Volunteers |
Drug: Lidocaine 7% + Tetracaine 7% cream |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Anesthetic Effect Duration Produced by Lidocaine 7% + Tetracaine 7% Cream on 2 Different Body Areas |
- Duration of anesthesia [ Time Frame: From product removal up to T8 hours after product removal ] [ Designated as safety issue: No ]Duration of anesthesia will be the difference between the onset and end of anesthesia.
- Adverse Events [ Time Frame: At Baseline, Day 2 and Day 4 (at each study visit) ] [ Designated as safety issue: Yes ]Incidence of adverse events will be reported
| Enrollment: | 30 |
| Study Start Date: | May 2012 |
| Study Completion Date: | May 2012 |
| Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: lidocaine 7% and tetracaine 7% |
Drug: Lidocaine 7% + Tetracaine 7% cream
Study drug will be applied with a different application time to one side of the face and anterior thigh according to the randomization list.
|
Detailed Description:
Subjects will have 4 target zones defined; 2 on the face and 2 on the anterior thighs. Upon inclusion into the study, subjects will have the study drug applied with a different application time to one side of the face and anterior thigh according to the randomization. After the completion of the application process, study drug on both sides of the face and on both anterior thighs will be removed by peeling.
After drug removal, the duration of anesthetic effect of the study drug will be tested using a pinprick test. Five (5) pinpricks using a 21-gauge needle will be performed at the 4 target zones (each side of the face and both anterior thighs). The pinprick test will be repeated up to 8 hours after drug removal. There will be a total of 20 post drug removal pinprick test completed.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations| United States, New Jersey | |
| Galderma Investigational center | |
| Rochelle Park, New Jersey, United States | |
| Principal Investigator: | Regina YAVEL, MD- Dermatologist | Galderma investigational center |
More Information
No publications provided
| Responsible Party: | Galderma |
| ClinicalTrials.gov Identifier: | NCT01545765 History of Changes |
| Other Study ID Numbers: | RD.03.SPR29103 |
| Study First Received: | February 24, 2012 |
| Last Updated: | June 14, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Galderma:
|
Healthy volunteers |
Additional relevant MeSH terms:
|
Anesthetics Tetracaine Lidocaine Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents |
Therapeutic Uses Anesthetics, Local Sensory System Agents Peripheral Nervous System Agents Anti-Arrhythmia Agents Cardiovascular Agents |
ClinicalTrials.gov processed this record on May 19, 2013