Healthy Volunteers
Conditions
Keywords
Healthy volunteers
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.
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.
Interventions
DRUGLidocaine 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.
Sponsors
Galderma R&D
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Anesthesia(Minutes) | From T0 (product removal) up to T8 hours after product removal | Onset and end of anesthesia are evaluated by Pinprick tests. Duration of anesthesia is calculated as: difference between onset and end of anesthesia (minutes). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | During the study | Incidence of adverse events was to be reported during the study period |
Countries
United States
Participant flow
Recruitment details
31 healthy volunteers have been enrolled in one Phase I center at USA.First subject in: May 3d 2012; Last subject ou: May 26th 2012.
Participants by arm
| Arm | Count |
|---|---|
| Lidocaine 7% and Tetracaine 7% | 31 |
| Total | 31 |
Baseline characteristics
| Characteristic | Lidocaine 7% and Tetracaine 7% |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 29 Participants |
| Age, Continuous | 47.2 years STANDARD_DEVIATION 1.27 |
| Region of Enrollment United States | 31 participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 2 / 31 |
| serious Total, serious adverse events | 0 / 31 |
Outcome results
Primary
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).
Time frame: From T0 (product removal) up to T8 hours after product removal
Population: A standard sample size for this type of study is 30 subjects. The analyses are performed on the safety population (APT), corresponding to the enrolled and randomized population, after exclusion of subjects who never applied the treatments with certainty. Missing data were to be treated as missing for all analyses.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Lidocaine 7% + Tetracaine 7% Face - First Application Time | Duration of Anesthesia(Minutes) | 80 Minutes |
| Lidocaine 7% + Tetracaine 7% Face - Second Application Time | Duration of Anesthesia(Minutes) | 140 Minutes |
| Lidocaine 7% + Tetracaine 7% Thigh - First Application Time | Duration of Anesthesia(Minutes) | 0 Minutes |
| Lidocaine 7% + Tetracaine 7% Thigh - Second Application Time | Duration of Anesthesia(Minutes) | 400 Minutes |
Secondary
Adverse Events
Incidence of adverse events was to be reported during the study period
Time frame: During the study
Population: A standard sample size for this type of study is 30 subjects. The analyses are performed on the safety population (APT), corresponding to the enrolled and randomized population, after exclusion of subjects who never applied the treatments with certainty. Missing data were to be treated as missing for all analyses.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lidocaine 7% + Tetracaine 7% Face - First Application Time | Adverse Events | 2 participants |
| Lidocaine 7% + Tetracaine 7% Face - Second Application Time | Adverse Events | 2 participants |
| Lidocaine 7% + Tetracaine 7% Thigh - First Application Time | Adverse Events | 2 participants |
| Lidocaine 7% + Tetracaine 7% Thigh - Second Application Time | Adverse Events | 2 participants |