Anesthetic Effect Duration Assessment

• Sponsor: Galderma R&D (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01545765
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arm: 1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: Lidocaine 7% + Tetracaine 7% cream	Phase 4

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Anesthetic Effect Duration Produced by Lidocaine 7% + Tetracaine 7% Cream on 2 Different Body Areas
• Study Start Date: May 1, 2012
• Actual Primary Completion Date: May 1, 2012
• Actual Study Completion Date: May 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. Adverse Events [During the study]

   Incidence of adverse events was to be reported during the study period

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• 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

Locations

	Site	City	State	Country	Postal Code
1	Galderma Investigational center	Rochelle Park	New Jersey	United States

Sponsors and Collaborators

• Galderma R&D

Investigators

• Principal Investigator: Regina YAVEL, MD- Dermatologist, Galderma investigational center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Galderma R&D
• ClinicalTrials.gov Identifier: NCT01545765
• Other Study ID Numbers: RD.03.SPR.29103
• First Posted: Mar 7, 2012
• Last Update Posted: Sep 2, 2021
• Last Verified: Jun 1, 2013

• Keywords provided by Galderma R&D: Healthy volunteers
• Additional relevant MeSH terms: Lidocaine; Tetracaine

Study Results

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.

Arm/Group Title	Face 2 Application Times/ Thight 2 Application Times
Arm/Group Description
Period Title: Overall Study
STARTED	31
COMPLETED	31
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Lidocaine 7% and Tetracaine 7%
Arm/Group Description
Overall Participants	31
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	29 93.5%
>=65 years	2 6.5%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	47.2 (1.27)
Sex: Female, Male (Count of Participants)
Female	20 64.5%
Male	11 35.5%
Region of Enrollment (participants) [Number]
United States	31 100%

Outcome Measures

1. Secondary Outcome

Title	Adverse Events
Description	Incidence of adverse events was to be reported during the study period
Time Frame	During the study

Outcome Measure Data

Analysis Population Description

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/Group Title	Lidocaine 7% + Tetracaine 7% Face - First Application Time	Lidocaine 7% + Tetracaine 7% Face - Second Application Time	Lidocaine 7% + Tetracaine 7% Thigh - First Application Time	Lidocaine 7% + Tetracaine 7% Thigh - Second Application Time
Arm/Group Description
Measure Participants	31	31	31	31
Number [participants]	2 6.5%	2 NaN	2 NaN	2 NaN

2. Primary Outcome

Title	Duration of Anesthesia(Minutes)
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Lidocaine 7% + Tetracaine 7% Face - First Application Time	Lidocaine 7% + Tetracaine 7% Face - Second Application Time	Lidocaine 7% + Tetracaine 7% Thigh - First Application Time	Lidocaine 7% + Tetracaine 7% Thigh - Second Application Time
Arm/Group Description
Measure Participants	31	31	31	31
Median (Full Range) [Minutes]	80	140	0	400

Adverse Events

Time Frame	All study period (from Baseline to end of teh study)
Adverse Event Reporting Description	Incidence of adverse events was to be reported during the study
Arm/Group Title	Lidocaine 7% + Tetracaine 7%
Arm/Group Description
All Cause Mortality
	Lidocaine 7% + Tetracaine 7%
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Lidocaine 7% + Tetracaine 7%
	Affected / at Risk (%)	# Events
Total	0/31 (0%)
Other (Not Including Serious) Adverse Events
	Lidocaine 7% + Tetracaine 7%
	Affected / at Risk (%)	# Events
Total	2/31 (6.5%)
Nervous system disorders
SINUS HEADACHE	1/31 (3.2%)	1
HEADACHE	1/31 (3.2%)	1
DIZZINESS	1/31 (3.2%)	1

Limitations/Caveats

No limitation or caveat on this study

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.