Trial Outcomes & Findings for Anesthetic Effect Duration Assessment (NCT NCT01545765)

Results Overview

Onset and end of anesthesia are evaluated by Pinprick tests. Duration of anesthesia is calculated as: difference between onset and end of anesthesia (minutes).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

30 participants

Primary outcome timeframe

From T0 (product removal) up to T8 hours after product removal

Results posted on

2021-09-02

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Face 2 Application Times/ Thight 2 Application Times
Overall Study STARTED	31
Overall Study COMPLETED	31
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Anesthetic Effect Duration Assessment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lidocaine 7% and Tetracaine 7% n=31 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	29 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Age, Continuous	47.2 years STANDARD_DEVIATION 1.27 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants
Region of Enrollment United States	31 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Onset and end of anesthesia are evaluated by Pinprick tests. Duration of anesthesia is calculated as: difference between onset and end of anesthesia (minutes).

Outcome measures

Outcome measures
Measure	Lidocaine 7% + Tetracaine 7% Face - First Application Time n=31 Participants	Lidocaine 7% + Tetracaine 7% Face - Second Application Time n=31 Participants	Lidocaine 7% + Tetracaine 7% Thigh - First Application Time n=31 Participants	Lidocaine 7% + Tetracaine 7% Thigh - Second Application Time n=31 Participants
Duration of Anesthesia(Minutes)	80 Minutes Interval 0.0 to 420.0	140 Minutes Interval 0.0 to 480.0	0 Minutes Interval 0.0 to 460.0	400 Minutes Interval 0.0 to 480.0

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Lidocaine 7% + Tetracaine 7% Face - First Application Time n=31 Participants	Lidocaine 7% + Tetracaine 7% Face - Second Application Time n=31 Participants	Lidocaine 7% + Tetracaine 7% Thigh - First Application Time n=31 Participants	Lidocaine 7% + Tetracaine 7% Thigh - Second Application Time n=31 Participants
Adverse Events	2 participants	2 participants	2 participants	2 participants

Adverse Events

Lidocaine 7% + Tetracaine 7%

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Lidocaine 7% + Tetracaine 7% n=31 participants at risk
Nervous system disorders SINUS HEADACHE	3.2% 1/31 • Number of events 1 • All study period (from Baseline to end of teh study) Incidence of adverse events was to be reported during the study
Nervous system disorders HEADACHE	3.2% 1/31 • Number of events 1 • All study period (from Baseline to end of teh study) Incidence of adverse events was to be reported during the study
Nervous system disorders DIZZINESS	3.2% 1/31 • Number of events 1 • All study period (from Baseline to end of teh study) Incidence of adverse events was to be reported during the study

Additional Information

Farzaneh Sidou Clinical Project Manager)

Galderma

Phone: 00.33.4.93.95.70.70

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER