Trial Outcomes & Findings for Safety and Efficacy of a Metallic Cannula Versus A Standard Needle for Soft Tissue Augmentation of the Nasolabial Folds (NCT NCT01066026)

Results Overview

Number of participants with haematoma at each visit

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

25 participants

Primary outcome timeframe

Day 1; day 3; day 7; day 90

Results posted on

2020-10-01

Participant Flow

Participant milestones

Participant milestones
Measure	Metallic Cannula Standard needle and metallic cannula were used in the same patient, with split face.
Overall Study STARTED	25
Overall Study COMPLETED	23
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Efficacy of a Metallic Cannula Versus A Standard Needle for Soft Tissue Augmentation of the Nasolabial Folds

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Metallic Cannula and Standart Cannula n=25 Participants Nasolabial Folds received fullers with Metallic Cannula or with Standard Needle
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	25 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	50 years STANDARD_DEVIATION 7 • n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment Brazil	25 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1; day 3; day 7; day 90

Number of participants with haematoma at each visit

Outcome measures

Outcome measures
Measure	Metallic Cannula n=25 Participants Split face; metallic cannula on one side of the face and standard needle on the contralateral side (same patient).	Standard Needle n=25 Participants Split face; metallic cannula on one side of the face and standard needle on the contralateral side (same patient).
Number of Participants With Haematoma Day 1	10 Participants	23 Participants
Number of Participants With Haematoma Day 3	6 Participants	11 Participants
Number of Participants With Haematoma Day 7	1 Participants	4 Participants
Number of Participants With Haematoma Day 90	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Day 1; day 3; day 7; day 90

Number of participants with erythema at each visit

Outcome measures

Outcome measures
Measure	Metallic Cannula n=25 Participants Split face; metallic cannula on one side of the face and standard needle on the contralateral side (same patient).	Standard Needle n=25 Participants Split face; metallic cannula on one side of the face and standard needle on the contralateral side (same patient).
Number of Participants With Erythema Day 1	22 Participants	25 Participants
Number of Participants With Erythema Day 3	0 Participants	1 Participants
Number of Participants With Erythema Day 7	0 Participants	0 Participants
Number of Participants With Erythema Day 90	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline and 90 days

Population: Per protocol analysis. 23 participants attended to visit "Day 90'.

Class 0 - No visible wrinkles; continuous skin lines Class 0.5 - Very shallow yet visible wrinkles Class 1 - Fine wrinkles. Visible wrinkles and slight indentations Class 1.5 - Visible wrinkles and clear indentations,\<1-mm wrinkle depth\* Class 2 - Moderate wrinkles. Clearly visible wrinkles, 1- to 2-mm wrinkle depth\* Class 2.5 - Prominent and visible wrinkles; 2- to 3-mm wrinkle depth\* Class 3 - Deep wrinkles. Deep, furrowed wrinkle; \*\>3-mm wrinkle depth

Outcome measures

Outcome measures
Measure	Metallic Cannula n=23 Participants Split face; metallic cannula on one side of the face and standard needle on the contralateral side (same patient).	Standard Needle n=23 Participants Split face; metallic cannula on one side of the face and standard needle on the contralateral side (same patient).
Modified Fitzpatrick Wrinkle Scale (MFWS) Baseline	2.40 scores on a scale Standard Deviation 0.37	2.40 scores on a scale Standard Deviation 0.37
Modified Fitzpatrick Wrinkle Scale (MFWS) Day 90	1.57 scores on a scale Standard Deviation 0.57	1.54 scores on a scale Standard Deviation 0.56

SECONDARY outcome

Timeframe: 90 days

Population: Per protocol analysis. 23 participants attended to visit "Day 90'.

1. Very much improved: Optimal cosmetic result for the implant in this patient 2. Much improved: Marked improvement in appearance from the initial condition but not completely optimal for this patient; touch-up would slightly improve the result 3 - Improved: Obvious improvement in appearance from the initial condition, but touch-up or retreatment is indicated 4 - No change: Appearance essentially the same as the original condition 5 - Worse: Appearance worse than the original condition

Outcome measures

Outcome measures
Measure	Metallic Cannula n=23 Participants Split face; metallic cannula on one side of the face and standard needle on the contralateral side (same patient).	Standard Needle n=23 Participants Split face; metallic cannula on one side of the face and standard needle on the contralateral side (same patient).
Global Aesthetic Improvement Scale	2 scores on a scale Standard Deviation 0.6	2 scores on a scale Standard Deviation 0.7

Adverse Events

Metallic Cannula

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Needle

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Doris Hexsel

Brazilian Center for Studies in Dermatology

Phone: 55 51 30262633

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place