Trial Outcomes & Findings for Efficacy of Injected Local Anesthetic vs Topical Anesthetic in Cosmetic Injectable Fillers. (NCT NCT02379221)

Results Overview

Patient will complete a questionnaire to evaluate his/her preference of anesthetic modality.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

49 participants

Primary outcome timeframe

one week post treatment

Results posted on

2020-04-29

Participant Flow

Participant milestones

Participant milestones
Measure	Injectable / Topical Half of the face is injected with local anesthesia, the other half is treated with topical anesthesia per randomized method. Injectable: 20% benzocaine, 2% lidocaine 1:100k epinephrine nerve block injection Topical: 4% Topicaine gel
Overall Study STARTED	49
Overall Study COMPLETED	48
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Injectable / Topical Half of the face is injected with local anesthesia, the other half is treated with topical anesthesia per randomized method. Injectable: 20% benzocaine, 2% lidocaine 1:100k epinephrine nerve block injection Topical: 4% Topicaine gel
Overall Study Lost to Follow-up	1

Baseline Characteristics

One participant dropped out before her follow up visit. We were not able to get complete data on this participant so we did not use her information.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Injectable / Topical n=48 Participants Half of the face is injected with local anesthesia, the other half is treated with topical anesthesia by randomized method. Injectable: 20% benzocaine, 2% lidocaine 1:100k epinephrine nerve block injection Topical: 4% Topicaine gel
Age, Categorical <=18 years	0 Participants n=5 Participants • One participant dropped out before her follow up visit. We were not able to get complete data on this participant so we did not use her information.
Age, Categorical Between 18 and 65 years	48 Participants n=5 Participants • One participant dropped out before her follow up visit. We were not able to get complete data on this participant so we did not use her information.
Age, Categorical >=65 years	0 Participants n=5 Participants • One participant dropped out before her follow up visit. We were not able to get complete data on this participant so we did not use her information.
Age, Continuous	53 years n=5 Participants
Sex: Female, Male Female	46 Participants n=5 Participants • One participant dropped out before completing study.
Sex: Female, Male Male	2 Participants n=5 Participants • One participant dropped out before completing study.
Region of Enrollment United States	48 participants n=5 Participants

PRIMARY outcome

Timeframe: one week post treatment

Patient will complete a questionnaire to evaluate his/her preference of anesthetic modality.

Outcome measures

Outcome measures
Measure	Injectable n=48 Participants Half of the face is injected with local anesthesia per randomized method. Injectable: 2% lidocaine 1:100k epinephrine nerve block injection Topical: 4% Topicaine gel	Topical n=48 Participants Half of the face is treated with topical anesthesia per randomized method Topical application of 20% benzocaine 4% lidocaine gel
Participants Anesthetic Preference	32 participant preference selection	16 participant preference selection

SECONDARY outcome

Timeframe: 5-10 minutes post-procedure

Participant will complete a questionnaire to evaluate his/her pain level perception using a Visual Analog Scale (VAS) during injection to the upper and lower lip. The Visual Analog scale uses a 10 cm horizontal line with 'no pain' labeled on the left end of line and 'worst pain' on the right end of line. Participant marks their pain level at any point on the line from no pain to worst pain. No pain= 0 cm, Worst pain=10cm

Outcome measures

Outcome measures
Measure	Injectable n=48 Participants Half of the face is injected with local anesthesia per randomized method. Injectable: 2% lidocaine 1:100k epinephrine nerve block injection Topical: 4% Topicaine gel	Topical n=48 Participants Half of the face is treated with topical anesthesia per randomized method Topical application of 20% benzocaine 4% lidocaine gel
Mean Pain Level Associated With the Local Anesthetic Injection	2.14 unit on a scale Standard Deviation 2.35	1.89 unit on a scale Standard Deviation 2.04

SECONDARY outcome

Timeframe: 5-10 min post procedure

Participant will complete a questionnaire to evaluate his/her pain level perception using a Visual Analog Scale (VAS) during application of topical anesthesia to the upper and lower lip. The Visual Analog scale uses a 10 cm horizontal line with 'no pain' labeled on the left end of line and 'worst pain' on the right end of line. Participant marks their pain level at any point on the line from no pain to worst pain. No pain= 0 cm, Worst pain=10cm

Outcome measures

Outcome measures
Measure	Injectable n=48 Participants Half of the face is injected with local anesthesia per randomized method. Injectable: 2% lidocaine 1:100k epinephrine nerve block injection Topical: 4% Topicaine gel	Topical n=48 Participants Half of the face is treated with topical anesthesia per randomized method Topical application of 20% benzocaine 4% lidocaine gel
Mean Pain Level Associated With the Local Topical Anesthetic	0.05 units on a scale Standard Deviation .21	0.11 units on a scale Standard Deviation .32

SECONDARY outcome

Timeframe: 5-10 minutes post procedure

Participant will complete a questionnaire to evaluate his/her pain level perception using a Visual Analog Scale (VAS) during injection of HA filler to the upper lip. The Visual Analog scale uses a 10 cm horizontal line with 'no pain' labeled on the left end of line and 'worst pain' on the right end of line. Participant marks their pain level at any point on the line from no pain to worst pain. No pain= 0 cm, Worst pain=10cm

Outcome measures

Outcome measures
Measure	Injectable n=48 Participants Half of the face is injected with local anesthesia per randomized method. Injectable: 2% lidocaine 1:100k epinephrine nerve block injection Topical: 4% Topicaine gel	Topical n=48 Participants Half of the face is treated with topical anesthesia per randomized method Topical application of 20% benzocaine 4% lidocaine gel
Mean Pain Level Associated With Facial Filler Injection at the Upper Lip	0.89 units on a scale Standard Deviation 1.60	3.67 units on a scale Standard Deviation 2.87

SECONDARY outcome

Timeframe: 5-10 minutes post procedure

A mean level of pain for all participants completing the Visual Analog Scale (VAS) during injection of HA filler to the lower lip. The Visual Analog scale uses a 10 cm horizontal line with 'no pain' labeled on the left end of line and 'worst pain' on the right end of line. Participant marks their pain level at any point on the line from no pain to worst pain. No pain= 0 cm, Worst pain=10cm. The total score was divided by 48.

Outcome measures

Outcome measures
Measure	Injectable n=48 Participants Half of the face is injected with local anesthesia per randomized method. Injectable: 2% lidocaine 1:100k epinephrine nerve block injection Topical: 4% Topicaine gel	Topical n=48 Participants Half of the face is treated with topical anesthesia per randomized method Topical application of 20% benzocaine 4% lidocaine gel
Mean Pain Level Associated With Facial Filler Injection to the Lower Lip	1.47 units on a scale Standard Deviation 2.41	4.38 units on a scale Standard Deviation 2.95

SECONDARY outcome

Timeframe: 5-10 minutes post procedure

Participant will complete a questionnaire to evaluate his/her pain level perception using a Visual Analog Scale (VAS) during injection of HA filler to the nasolabial fold. The Visual Analog scale uses a 10 cm horizontal line with 'no pain' labeled on the left end of line and 'worst pain' on the right end of line. Participant marks their pain level at any point on the line from no pain to worst pain. No pain= 0 cm, Worst pain=10cm

Outcome measures

Outcome measures
Measure	Injectable n=48 Participants Half of the face is injected with local anesthesia per randomized method. Injectable: 2% lidocaine 1:100k epinephrine nerve block injection Topical: 4% Topicaine gel	Topical n=48 Participants Half of the face is treated with topical anesthesia per randomized method Topical application of 20% benzocaine 4% lidocaine gel
Mean Pain Level Associated With Facial Filler Injection to the Nasolabial Fold	0.76 units on a scale Standard Deviation 1.49	2.82 units on a scale Standard Deviation 2.54

Adverse Events

Injectable / Topical

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Injectable / Topical n=49 participants at risk One side of face is injected with local anesthesia, the other side is treated with topical anesthesia per randomization. Injectable: 20% benzocaine, 2% lidocaine 1:100k epinephrine nerve block injection Topical: 4% Topicaine gel
Vascular disorders Syncopal Episode	2.0% 1/49 • Number of events 1 • one week

Additional Information

Dr. Jason May

Travis AFB OMFS Clinic

Phone: 707-423-7085

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place