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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| lidocaine 7% and tetracaine 7% | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine 7% + Tetracaine 7% cream | Drug | Study drug will be applied with a different application time to one side of the face and anterior thigh according to the randomization list. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Incidence of adverse events was to be reported during the study period | During the study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Regina YAVEL, MD- Dermatologist | Galderma investigational center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Galderma Investigational center | Rochelle Park | New Jersey | United States |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Face 2 Application Times/ Thight 2 Application Times |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
No sample size determination as a standard sample size for this type of study is about 30 subjects.
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| ID | Title | Description |
|---|---|---|
| BG000 | Lidocaine 7% and Tetracaine 7% |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Adverse Events | Incidence of adverse events was to be reported during the study period | 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. | Posted | Number | participants | During the study |
|
All study period (from Baseline to end of teh study)
Incidence of adverse events was to be reported during the study
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lidocaine 7% + Tetracaine 7% |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| SINUS HEADACHE | Nervous system disorders | MedDRA (14.0) | Non-systematic Assessment |
No limitation or caveat on this study
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Farzaneh Sidou Clinical Project Manager) | Galderma | 00.33.4.93.95.70.70 | farzaneh.sidou@galderma.com |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D013748 | Tetracaine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Lidocaine 7% + Tetracaine 7% Thigh - First Application Time |
| OG003 | Lidocaine 7% + Tetracaine 7% Thigh - Second Application Time |
|
|
| 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). | 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. | Posted | Median | Full Range | Minutes | From T0 (product removal) up to T8 hours after product removal |
|
|
|
| 0 |
| 31 |
| 2 |
| 31 |
| HEADACHE | Nervous system disorders | MedDRA (14.0) | Non-systematic Assessment |
|
| DIZZINESS | Nervous system disorders | MedDRA (14.0) | Non-systematic Assessment |
|
Any intent of the investigator to publish or disclose in any way the information requires the sponsor's prior written approval. The investigator shall provide their draft of such publication to sponsor to review and approval at least 2 months prior to the date of intended publication. Sponsor shall have the absolute right to determine whether information may be published by the investigator.
| Aniline Compounds |
| D000588 | Amines |
| D062366 | para-Aminobenzoates |
| D062365 | Aminobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |