Anesthetic Effect Duration Assessment
Anesthetic Effect Duration Produced by Lidocaine 7% + Tetracaine 7% Cream on 2 Different Body Areas
1 other identifier
interventional
30
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 healthy-volunteers
Started May 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 24, 2012
CompletedFirst Posted
Study publicly available on registry
March 7, 2012
CompletedStudy Start
First participant enrolled
May 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedResults Posted
Study results publicly available
September 4, 2013
CompletedSeptember 2, 2021
June 1, 2013
Same day
February 24, 2012
June 25, 2013
August 31, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Duration of Anesthesia(Minutes)
Onset and end of anesthesia are evaluated by Pinprick tests. Duration of anesthesia is calculated as: difference between onset and end of anesthesia (minutes).
From T0 (product removal) up to T8 hours after product removal
Secondary Outcomes (1)
Adverse Events
During the study
Study Arms (1)
lidocaine 7% and tetracaine 7%
EXPERIMENTALInterventions
Study drug will be applied with a different application time to one side of the face and anterior thigh according to the randomization list.
Eligibility Criteria
You may qualify if:
- Healthy male of female subjects aged 18 or older with a normal not excessive hairy skin,
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Galderma R&Dlead
Study Sites (1)
Galderma Investigational center
Rochelle Park, New Jersey, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Limitations and Caveats
No limitation or caveat on this study
Results Point of Contact
- Title
- Farzaneh Sidou Clinical Project Manager)
- Organization
- Galderma
Study Officials
- PRINCIPAL INVESTIGATOR
Regina YAVEL, MD- Dermatologist
Galderma investigational center
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 24, 2012
First Posted
March 7, 2012
Study Start
May 1, 2012
Primary Completion
May 1, 2012
Study Completion
May 1, 2012
Last Updated
September 2, 2021
Results First Posted
September 4, 2013
Record last verified: 2013-06