Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metallic cannula | Experimental | Nasolabial Fold with metallic cannula and hyaluronic acid injected. hyaluronic acid with metallic cannula or standard needle. Hyaluronic acid injected with the new tool |
|
| Standard needle | Active Comparator | Nasolabial Fold with standard needle and hyaluronic acid injected. hyaluronic acid with metallic cannula or standard needle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hyaluronic acid with metallic cannula or standard needle. | Procedure | 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:
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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Haematoma | Number of participants with haematoma at each visit | Day 1; day 3; day 7; day 90 |
| Number of Participants With Erythema | Number of participants with erythema at each visit | Day 1; day 3; day 7; day 90 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Doris Hesxel, MD | CBED | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brazilian Center for Studies in Dermatology | Porto Alegre | Rio Grande do Sul | 90570-040 | Brazil | ||
| Centro Brasileiro de Estudos em Dermatologia |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Metallic Cannula | Standard needle and metallic cannula were used in the same patient, with split face. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Hyaluronic acid injected with the new tool. | Drug | hyaluronic acid with metallic cannula. |
|
|
| Baseline and 90 days |
| Global Aesthetic Improvement Scale |
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 | 90 days |
| Porto Alegre |
| Brazil |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Metallic Cannula and Standart Cannula | Nasolabial Folds received fullers with Metallic Cannula or with Standard Needle |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Haematoma | Number of participants with haematoma at each visit | Posted | Count of Participants | Participants | Day 1; day 3; day 7; day 90 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Erythema | Number of participants with erythema at each visit | Posted | Count of Participants | Participants | Day 1; day 3; day 7; day 90 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 | Per protocol analysis. 23 participants attended to visit "Day 90'. | Posted | Mean | Standard Deviation | scores on a scale | Baseline and 90 days |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Global Aesthetic Improvement Scale |
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 | Per protocol analysis. 23 participants attended to visit "Day 90'. | Posted | Mean | Standard Deviation | scores on a scale | 90 days |
|
|
3 months
pain,
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Metallic Cannula | Nasolabial Fold with Metallic Cannula | 0 | 25 | 0 | 25 | ||
| EG001 | Standard Needle | Nasolabial Fold with standard needle | 0 | 25 | 0 | 25 |
Not provided
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Doris Hexsel | Brazilian Center for Studies in Dermatology | 55 51 30262633 | cientifico@cbed.org.br |
| ID | Term |
|---|---|
| D006820 | Hyaluronic Acid |
| C445361 | Restylane |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
Not provided
Not provided
| Day 7 |
|
| Day 90 |
|
|
|
|