Duration of Skin Numbing Effect Created by the S-Caine™ Peel
A Randomized, Double-Blind, Paired, Placebo Controlled Study Evaluating the Duration of Anesthetic Effect Produced by the S-Caine™ Peel (Lidocaine 7% and Tetracaine 7% Cream) When Applied for 30 and 60 Minutes
1 other identifier
interventional
40
1 country
1
Brief Summary
S-Caine™ Peel (lidocaine 7% and tetracaine 7% cream) is a new skin numbing cream made of lidocaine and tetracaine. The purpose of this study is to evaluate and measure the length of time the S-Caine Peel numbs the skin, when applied for 30 and 60 minutes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 pain
Started Jun 2005
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
May 4, 2005
CompletedFirst Posted
Study publicly available on registry
May 5, 2005
CompletedStudy Start
First participant enrolled
June 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2005
CompletedJune 5, 2012
June 1, 2012
Same day
May 4, 2005
June 4, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Duration of anesthetic effect
The duration of anesthesia was defined as the difference between the onset and end of anesthesia. If there was no onset of anesthesia, the duration was defined as zero. Onset of anesthesia was defined as the first time that the number of painful pinpricks was 2 or less (out of 5) for 2 consecutive time points. For subjects/treatments with onset of anesthesia, the end of anesthesia was defined as the first time after onset when the number of painful pinpricks was 3 or more for 2 consecutive time points
first time after onset when the number of painful pinpricks was 3 or more for 2 consecutive time points
Secondary Outcomes (1)
Number of participants with adverse events
72 hours
Study Arms (1)
S-Caine Peel
EXPERIMENTALInterventions
S-Caine Peel is composed of a 1:1 eutectic mixture of 7% lidocaine, and 7% tetracaine, which was applied topically. The S Caine Peel was applied at approximately 1 mm in thickness and remained on the treatment area for 30 or 60 minutes
Eligibility Criteria
You may qualify if:
- Subject is 18 years of age or older.
- Meet pinprick test requirements.
You may not qualify if:
- Subject is pregnant or breastfeeding.
- Subject has participated in a clinical trial of an unapproved drug within the previous 30 days.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ZARS Pharma Inc.lead
Study Sites (1)
Radiant Research
San Diego, California, 92123, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
William Garland, MD
Radiant Research San Diego
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 4, 2005
First Posted
May 5, 2005
Study Start
June 1, 2005
Primary Completion
June 1, 2005
Study Completion
June 1, 2005
Last Updated
June 5, 2012
Record last verified: 2012-06