WrinklesPhase 2NCT01066026
Safety and Efficacy of a Metallic Cannula Versus A Standard Needle for Soft Tissue Augmentation of the Nasolabial Folds
A Phase 2 study testing hyaluronic acid with metallic cannula or standard needle. and Hyaluronic acid injected with the new tool. in people with Wrinkles, run by Hexsel Dermatology Clinic at 2 sites in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Wrinkles
- What is being tested?
- hyaluronic acid with metallic cannula or standard needle. and Hyaluronic acid injected with the new tool.
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesBrazil
- Study dates
- Jul 2009to Mar 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 9Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Brazilian Center for Studies in Dermatology
Porto Alegre, Rio Grande do Sul, 90570-040
Centro Brasileiro de Estudos em Dermatologia
Porto Alegre
About this study
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
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.
Read the 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.
- Conditions
- Wrinkles
- Being tested
- hyaluronic acid with metallic cannula or standard needle., Hyaluronic acid injected with the new tool.
- Keywords
- metallic cannula, Hyaluronic acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hyaluronic acid with metallic cannula or standard needle.Procedure or surgery
Also called Restylane
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.
Hyaluronic acid injected with the new tool.Drug
Also called Restylane
hyaluronic acid with metallic cannula.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: hyaluronic acid with metallic cannula or standard needle.; Drug: 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. Receives: Procedure: hyaluronic acid with metallic cannula or standard needle. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Haematoma
Number of participants with haematoma at each visit
Measured: Day 1; day 3; day 7; day 90
Number of Participants With Erythema
Number of participants with erythema at each visit
Measured: Day 1; day 3; day 7; day 90
Secondary outcomes (2)
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
Measured: Baseline and 90 days
Global Aesthetic Improvement Scale
- 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
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2010 (estimated)
- Study startJul 2009
- Primary completionJan 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for WrinklesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hexsel Dermatology Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doris Hexsel, Hexsel Dermatology Clinic
- Investigators
- Doris Hesxel, MD, Principal investigator, CBED
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01066026
- Sponsor's protocol ID
- 08-CBED08-02
- Status last verified
- Sep 2020
- First submitted
- 26 Jan 2010
- Last updated
- 1 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01066026
- Acronym / sponsor ID
- 08-CBED08-02
- Conditions
- Wrinkles
- Keywords
- metallic cannula, Hyaluronic acid
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Hexsel Dermatology ClinicUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 10 Feb 2010 (estimated)
- Results
- Posted 9 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metallic cannula | Experimental | Procedure: hyaluronic acid with metallic cannula or standard needle., Drug: Hyaluronic acid injected with the new tool.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 | Procedure: hyaluronic acid with metallic cannula or standard needle.Nasolabial Fold with standard needle and hyaluronic acid injected. hyaluronic acid with metallic cannula or standard needle. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hyaluronic acid with metallic cannula or standard needle.Also: RestylaneThe 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. | Procedure or surgery | Metallic cannula, Standard needle |
| Hyaluronic acid injected with the new tool.Also: Restylanehyaluronic acid with metallic cannula. | Drug | Metallic cannula |
Primary outcome
Number of Participants With Haematoma
Time frame: Day 1; day 3; day 7; day 90
Number of participants with haematoma at each visit
Number of Participants With Erythema
Time frame: Day 1; day 3; day 7; day 90
Number of participants with erythema at each visit
2 secondary outcomes
Modified Fitzpatrick Wrinkle Scale (MFWS)
Time frame: Baseline and 90 days
Global Aesthetic Improvement Scale
Time frame: 90 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Doris Hesxel, MD principal investigator
CBED
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing hyaluronic acid with metallic cannula or standard needle. and Hyaluronic acid injected with the new tool. in people with Wrinkles, run by Hexsel Dermatology Clinic at 2 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Haematoma (time frame: Day 1; day 3; day 7; day 90). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2020.