Wrinkles
Conditions
Keywords
metallic cannula, Hyaluronic acid
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.
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.
Interventions
PROCEDUREhyaluronic 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.
DRUGHyaluronic acid injected with the new tool.
hyaluronic acid with metallic cannula.
Sponsors
Hexsel Dermatology Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Haematoma | Day 1; day 3; day 7; day 90 | Number of participants with haematoma at each visit |
| Number of Participants With Erythema | Day 1; day 3; day 7; day 90 | Number of participants with erythema at each visit |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Global Aesthetic Improvement Scale | 90 days | 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 |
Countries
Brazil
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Metallic Cannula and Standart Cannula Nasolabial Folds received fullers with Metallic Cannula or with Standard Needle | 25 |
| Total | 25 |
Baseline characteristics
| Characteristic | Metallic Cannula and Standart Cannula |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 25 Participants |
| Age, Continuous | 50 years STANDARD_DEVIATION 7 |
| Region of Enrollment Brazil | 25 participants |
| Sex: Female, Male Female | 25 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 25 | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 |
Outcome results
Primary
Number of Participants With Erythema
Number of participants with erythema at each visit
Time frame: Day 1; day 3; day 7; day 90
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Metallic Cannula | Number of Participants With Erythema | Day 1 | 22 Participants |
| Metallic Cannula | Number of Participants With Erythema | Day 3 | 0 Participants |
| Metallic Cannula | Number of Participants With Erythema | Day 7 | 0 Participants |
| Metallic Cannula | Number of Participants With Erythema | Day 90 | 0 Participants |
| Standard Needle | Number of Participants With Erythema | Day 90 | 0 Participants |
| Standard Needle | Number of Participants With Erythema | Day 1 | 25 Participants |
| Standard Needle | Number of Participants With Erythema | Day 7 | 0 Participants |
| Standard Needle | Number of Participants With Erythema | Day 3 | 1 Participants |
Primary
Number of Participants With Haematoma
Number of participants with haematoma at each visit
Time frame: Day 1; day 3; day 7; day 90
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Metallic Cannula | Number of Participants With Haematoma | Day 1 | 10 Participants |
| Metallic Cannula | Number of Participants With Haematoma | Day 3 | 6 Participants |
| Metallic Cannula | Number of Participants With Haematoma | Day 7 | 1 Participants |
| Metallic Cannula | Number of Participants With Haematoma | Day 90 | 0 Participants |
| Standard Needle | Number of Participants With Haematoma | Day 90 | 0 Participants |
| Standard Needle | Number of Participants With Haematoma | Day 1 | 23 Participants |
| Standard Needle | Number of Participants With Haematoma | Day 7 | 4 Participants |
| Standard Needle | Number of Participants With Haematoma | Day 3 | 11 Participants |
p-value: <0.000195% CI: [5, 95]McNemar
Secondary
Global Aesthetic Improvement Scale
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
Time frame: 90 days
Population: Per protocol analysis. 23 participants attended to visit Day 90'.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Metallic Cannula | Global Aesthetic Improvement Scale | 2 scores on a scale | Standard Deviation 0.6 |
| Standard Needle | Global Aesthetic Improvement Scale | 2 scores on a scale | Standard Deviation 0.7 |
Secondary
Modified Fitzpatrick Wrinkle Scale (MFWS)
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
Population: Per protocol analysis. 23 participants attended to visit Day 90'.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Metallic Cannula | Modified Fitzpatrick Wrinkle Scale (MFWS) | Baseline | 2.40 scores on a scale | Standard Deviation 0.37 |
| Metallic Cannula | Modified Fitzpatrick Wrinkle Scale (MFWS) | Day 90 | 1.57 scores on a scale | Standard Deviation 0.57 |
| Standard Needle | Modified Fitzpatrick Wrinkle Scale (MFWS) | Baseline | 2.40 scores on a scale | Standard Deviation 0.37 |
| Standard Needle | Modified Fitzpatrick Wrinkle Scale (MFWS) | Day 90 | 1.54 scores on a scale | Standard Deviation 0.56 |