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

• Sponsor: Brazilan Center for Studies in Dermatology (Other)
• Overall Status: Completed
• CT.gov ID: NCT01066026
• Collaborator: (none)
• Enrollment: 25
• Locations: 2
• Arms: 2
• Duration (Months): 8
• Patients Per Site: 12.5
• Patients Per Site Per Month: 1.6

Study Details

Study Description

Brief Summary

The purpose of this study was to assess the safety and efficacy of a new metallic cannula to inject hyaluronic acid for dermal augmentation in the nasolabial folds compared to standard needle.

Condition or Disease	Intervention/Treatment	Phase
Wrinkles	Procedure: hyaluronic acid with metallic cannula or standard needle.; Drug: Hyaluronic acid injected with the new tool.	Phase 2

Detailed Description

This was a monocentric, prospective, randomized, phase II and double-blind study.

At the baseline visits, one investigator rated the severity of nasolabial folds on both left and right sides according to the mentioned scale, and a standard set of six photographs of the face (frontal, left side and right side for both the whole face and the lower face) were taken.

On the day of the injection, the main investigator injected 1ml of dermal filler - hyaluronic acid (Restylane®, Q-Med, Uppsala, Sweden) - for each subject. The injected amount was 0,5ml for the right nasolabial fold and 0,5ml for the left nasolabial fold. The sides will be randomized.

Study Design

• Study Type: Interventional
• Actual Enrollment: 25 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Double-blind, Randomized and Controlled Clinical Trial to Compare Safety and Efficacy of a Metallic Cannula vs a Standard Needle for the Injection of Hyaluronic Acid Gel Dermal Filler (Restylane®) to Treat Nasolabial Folds
• Study Start Date: Jul 1, 2009
• Actual Primary Completion Date: Jan 1, 2010
• Actual Study Completion Date: Mar 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Metallic cannula Nasolabial Fold with metallic cannula and hyaluronic acid injected. hyaluronic acid with metallic cannula or standard needle. Hyaluronic acid injected with the new tool	Procedure: hyaluronic acid with metallic cannula or standard needle.; The sides of injection were randomized and both the subject and the evaluator were blind to it. The injections were performed according through two different devices: In one of the sides, the hyaluronic acid (Restylane®) was injected in its conventional pharmaceutical presentation, with a standard needle which is part of the product's kit; In the other side, the hyaluronic acid (Restylane®) was injected through a metallic cannula, which replaced the needle of the product's kit. Local analgesia was provided for both applications: topical analgesics 4% Lidocaine, for the application with the standard needle, and nerve block (Lidocaine 2%), where the application was performed with the metallic cannula.; Other Names: Restylane ; Drug: Hyaluronic acid injected with the new tool.; hyaluronic acid with metallic cannula.; Other Names: Restylane
Active Comparator: Standard needle Nasolabial Fold with standard needle and hyaluronic acid injected. hyaluronic acid with metallic cannula or standard needle.	Procedure: hyaluronic acid with metallic cannula or standard needle.; The sides of injection were randomized and both the subject and the evaluator were blind to it. The injections were performed according through two different devices: In one of the sides, the hyaluronic acid (Restylane®) was injected in its conventional pharmaceutical presentation, with a standard needle which is part of the product's kit; In the other side, the hyaluronic acid (Restylane®) was injected through a metallic cannula, which replaced the needle of the product's kit. Local analgesia was provided for both applications: topical analgesics 4% Lidocaine, for the application with the standard needle, and nerve block (Lidocaine 2%), where the application was performed with the metallic cannula.; Other Names: Restylane

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Haematoma [Day 1; day 3; day 7; day 90]

   Number of participants with haematoma at each visit

2. Number of Participants With Erythema [Day 1; day 3; day 7; day 90]

   Number of participants with erythema at each visit

Secondary Outcome Measures

1. Modified Fitzpatrick Wrinkle Scale (MFWS) [Baseline and 90 days]

   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

2. Global Aesthetic Improvement Scale [90 days]

   Very much improved: Optimal cosmetic result for the implant in this patient 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Subjects agreeing to take part of the study, after being fully informed of the purpose and the nature of the investigation and after having signed the informed consent form

• Female subjects aged from 18 to 60

• Fitzpatrick phototype I to VI

• Presence of bilateral folds graded from 2 to 3 according to the Modified

• Fitzpatrick Wrinkle Scale

• Subjects that have never performed any treatment of nasolabial folds

• Female subjects of childbearing age that present a negative urine pregnancy test and are using an effective contraceptive method

• Subjects who will be available throughout the duration of the study

• Subjects with sufficient schooling and awareness to enable them to cooperate to the degree required by this protocol.

Exclusion Criteria:

• Use of systemic corticosteroids

• History of herpes in lip

• Inflammation or active infection in the area to be injected

• Any surgical treatment or cosmetic procedure in the area to be injected that interfere in study's outcomes

• Coagulation disorders or use of anticoagulants

• Previous hypersensitivity responses to Hyaluronic acid.

• Pregnant or women in breastfeeding, or women planning to become pregnant

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Brazilian Center for Studies in Dermatology	Porto Alegre	Rio Grande Do Sul	Brazil	90570-040
2	Centro Brasileiro de Estudos em Dermatologia	Porto Alegre		Brazil

Sponsors and Collaborators

• Brazilan Center for Studies in Dermatology

Investigators

• Principal Investigator: Doris Hesxel, MD, CBED

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Doris Hexsel, MD, Brazilan Center for Studies in Dermatology
• ClinicalTrials.gov Identifier: NCT01066026
• Other Study ID Numbers: 08-CBED08-02
• First Posted: Feb 10, 2010
• Last Update Posted: Oct 1, 2020
• Last Verified: Sep 1, 2020

• Keywords provided by Doris Hexsel, MD, Brazilan Center for Studies in Dermatology: metallic cannula; Hyaluronic acid
• Additional relevant MeSH terms: Hyaluronic Acid

Study Results

Participant Flow

Arm/Group Title	Metallic Cannula
Arm/Group Description	Standard needle and metallic cannula were used in the same patient, with split face.
Period Title: Overall Study
STARTED	25
COMPLETED	23
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	Metallic Cannula and Standart Cannula
Arm/Group Description	Nasolabial Folds received fullers with Metallic Cannula or with Standard Needle
Overall Participants	25
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	25 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	50 (7)
Sex: Female, Male (Count of Participants)
Female	25 100%
Male	0 0%
Region of Enrollment (participants) [Number]
Brazil	25 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Haematoma
Description	Number of participants with haematoma at each visit
Time Frame	Day 1; day 3; day 7; day 90

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Metallic Cannula	Standard Needle
Arm/Group Description	Split face; metallic cannula on one side of the face and standard needle on the contralateral side (same patient).	Split face; metallic cannula on one side of the face and standard needle on the contralateral side (same patient).
Measure Participants	25	25
Day 1	10 40%	23 NaN
Day 3	6 24%	11 NaN
Day 7	1 4%	4 NaN
Day 90	0 0%	0 NaN

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Metallic Cannula, Standard Needle
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence (legacy)
	Comments	pilot study.
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	McNemar
	Comments
Method of Estimation	Estimation Parameter	descritive variables
	Estimated Value	50
	Confidence Interval	(2-Sided) 95%; 5 to 95
	Parameter Dispersion	Type: Value:
	Estimation Comments	50 was the percentage of hematomas expected for standard needle group.

2. Primary Outcome

Title	Number of Participants With Erythema
Description	Number of participants with erythema at each visit
Time Frame	Day 1; day 3; day 7; day 90

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Metallic Cannula	Standard Needle
Arm/Group Description	Split face; metallic cannula on one side of the face and standard needle on the contralateral side (same patient).	Split face; metallic cannula on one side of the face and standard needle on the contralateral side (same patient).
Measure Participants	25	25
Day 1	22 88%	25 NaN
Day 3	0 0%	1 NaN
Day 7	0 0%	0 NaN
Day 90	0 0%	0 NaN

3. Secondary Outcome

Title	Modified Fitzpatrick Wrinkle Scale (MFWS)
Description	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
Time Frame	Baseline and 90 days

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Metallic Cannula	Standard Needle
Arm/Group Description	Split face; metallic cannula on one side of the face and standard needle on the contralateral side (same patient).	Split face; metallic cannula on one side of the face and standard needle on the contralateral side (same patient).
Measure Participants	23	23
Baseline	2.40 (0.37)	2.40 (0.37)
Day 90	1.57 (0.57)	1.54 (0.56)

4. Secondary Outcome

Title	Global Aesthetic Improvement Scale
Description	Very much improved: Optimal cosmetic result for the implant in this patient 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
Time Frame	90 days

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Metallic Cannula	Standard Needle
Arm/Group Description	Split face; metallic cannula on one side of the face and standard needle on the contralateral side (same patient).	Split face; metallic cannula on one side of the face and standard needle on the contralateral side (same patient).
Measure Participants	23	23
Mean (Standard Deviation) [scores on a scale]	2 (0.6)	2 (0.7)

Adverse Events

Time Frame	3 months
Adverse Event Reporting Description	pain,
Arm/Group Title	Metallic Cannula		Standard Needle
Arm/Group Description	Nasolabial Fold with Metallic Cannula		Nasolabial Fold with standard needle
All Cause Mortality
	Metallic Cannula		Standard Needle
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Metallic Cannula		Standard Needle
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/25 (0%)
Other (Not Including Serious) Adverse Events
	Metallic Cannula		Standard Needle
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/25 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.