Wrinkles Such as Nasolabial FoldsPhase 3NCT04174131
Restylane + Lidocaine and Restylane Lyft for the Treatment of Nasolabial Folds
A Phase 3 study testing Restylane + Lidocaine and Restylane® Lyft in people with Wrinkles Such as Nasolabial Folds, run by Erevna Innovations Inc. at 1 site in Canada.
Trial summary
This study is designed to assess and compare the efficacy of two hyaluronic acid (HA) fillers on moderate, severe and extreme nasolabial folds (NLF). Read more about this study
- Who is it for?
- Ages 30 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Wrinkles Such as Nasolabial Folds
- What is being tested?
- Restylane + Lidocaine and Restylane® Lyft
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- 13 Nov 2019to 12 Feb 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 30 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At the time of consent, women between the ages of 30 and 75 years old;
- Indication for treatment of bilateral NLFs and wrinkles;
- Willingness to comply with study requirements;
- Provide written consent;
- Accepted the obligation not to receive any other facial procedures through the follow-up;
- Understood and accepted the obligation and would be logistically able to appear for all scheduled follow-up visits;
- No previous facial fillers for a period of 12 months prior to this study;
- No previous facial fillers in the complete region of the NLF for 18 months prior to this study
Who cannot join
- Current pregnancy or lactation [sexually active women of childbearing age must agree to use medically acceptable methods of contraception for the duration of this study (e.g., oral contraceptives, condoms, intrauterine device, shot/injection, patch)];
- Hypersensitivity to hyaluronic acid or local anesthetics;
- Patients meeting any official Restylane contra-indications;
- Patients presenting with porphyria;
- Inability to comply with follow-up and abstain from facial injections during the study period;
- Heavy smokers, classified as smoking more than 12 cigarettes per day;
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- History of severe or multiple allergies manifested by anaphylaxis;
- Previous tissue revitalization therapy in the treatment area within 6 months before treatment with laser or light, mesotherapy, radiofrequency, ultrasound, cryotherapy, chemical peeling, or dermabrasion;
- Previous maxillofacial surgery including aesthetic facial surgical therapy or liposuction, piercing, or tattoos in the treatment area;
- History or presence of any disease or lesion near or at the treatment area, including inflammation, active or chronic infection, including in the mouth, dentals, head and neck region;
- Facial psoriasis, eczema, acne, rosacea, perioral dermatitis and herpes zoster in the treatment area;
- Cancer or precancer in the treatment area, e.g. actinic keratosis;
- History of bleeding disorders or treatment with thrombolytics, anticoagulants, or inhibitors of platelet aggregation (e.g. Aspirin or other non-steroid anti-inflammatory drugs [NSAIDs]), within 2 weeks before treatment;
- Patients using immunosuppressants;
- Patients with a tendency to form hypertrophic scars or any other healing disorders;
- Patients with known hypersensitivity to lidocaine or agents structurally related to amide type local anaesthetics (e.g., certain anti-arrhythmics);
- Patients administered dental block or topical administration of lidocaine;
- Patients with epilepsy, impaired cardiac conduction, severely impaired hepatic function or severe renal dysfunction.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Split-face, Randomized, Comparative Trial on the Efficacy of Two Hyaluronic Acid Products (Restylane + Lidocaine and Restylane Lyft) for the Treatment of Nasolabial Folds
This study is designed to assess and compare the efficacy of two hyaluronic acid (HA) fillers on moderate, severe and extreme nasolabial folds (NLF).
Read the detailed description
Background
One of the most significant signs of aging is the appearance of deep lines that run from each side of the nose to the corners of the mouth [i.e., nasolabial folds (NLFs)]. These folds are defined by facial structures that support the buccal fat pad and separate the cheeks from the upper lip. The NLFs form due to volume shifts in the face, caused by a combination of fat descent and bone absorption, which results in sagging skin and hollowing.
Soft tissue augmentation can effectively restore the youthful, harmonious contours of the face. The most popular non-invasive treatment options for volume loss in the face include the use of hyaluronic acid (HA) fillers. Injections of HA for skin rejuvenation are one of the most common aesthetic treatments performed worldwide. Due to their effectiveness, safety, low immunogenicity (HA is a normal component of human skin) and reversibility with hyaluronidase, HA fillers are understandably a popular option for facial volume restoration.
Through recent advances in manufacturing technology, various types of HA fillers have been approved for the correction of facial wrinkles and folds, such as NLFs. Two such fillers, i) Restylane + Lidocaine and ii) Restylane Lyft, are well tolerated and provide significant improvement in this indication. These products contain the same amount of HA (i.e., 20mg/mL) and are manufactured using the same technology [i.e., non-animal stabilized hyaluronic acid (NASHATM)], but differ primarily in their particle size.
Small particle size HA (Restylane + Lidocaine): was the first non-animal stabilized HA-containing filler approved for use in the United States. Because of its particle size (i.e., 330-430 μM), Restylane + Lidocaine is referred to as small gel-particle HA (SGP-HA). NASHA small gel contains approximately 100,000 gel particles per mL.
Large particle size HA (Restylane Lyft): was approved in the United States in 2010 and is considered a large gel particle hyaluronic acid (LGP-HA). Restylane Lyft also contains the anesthetic lidocaine. NASHA large gel contains approximately 10,000 gel particles per mL.
The difference in gel size between the two products results in different viscosity and lifting capabilities, which is anticipated to affect treatment outcomes. While the comparative research is limited, a small number of clinical trials have compared the two products. For example, two randomized studies performed using US populations have shown equivalent safety and similar efficacy of Restylane + Lidocaine and Restylane Lyft, in subjects of all Fitzpatrick skin types; and one recent study found that both products exhibit similar safety and efficacy in a Chinese population. These three comparative studies found no significant differences in safety of LGP- and SGP-HA however, efficacy changes can occur due to the injection techniques and depth of injection used by the investigators.
This study is designed to assess and compare the efficacy of these two HA fillers on moderate, severe and extreme NLF, when using a modified technique. This modified technique will use a single puncture technique in each NLF, in comparison to others who have used a multi puncture, fanning or linear threading injection technique. For each NLF, a single bolus of product will be placed within the nasal pyriform aperture, on the periosteum. The location of the puncture will also vary from previous trials, in which injections were performed directly within the NLFs (to replace soft tissue volume). It is hypothesized that when these two products are used for replacing bone loss due to age-related resorption in the pyriform aperture, differences in efficacy will be observed that are not evident when they are used in soft tissue for volume augmentation. It is expected that while aesthetic outcomes and longevity of effect may be similar between the two products, the volumes required to achieve these same results will differ significantly, due to their different particle sizes.
Study Rationale
Larger HA gel particles result in better lifting capacities. Therefore, Restylane Lyft should display better efficacy in comparison to Restylane + Lidocaine when a "firm" product with a high lift capacity is required, such as when trying to replace or reshape bone. This is in contrast to replacing soft tissue volume, which was evaluated in earlier studies. However, as previous authors have reported, when these two products are used to replace soft tissue volume they both provide adequate lifting capabilities and thus result in similar efficacy levels.
- Conditions
- Wrinkles Such as Nasolabial Folds
- Being tested
- Restylane + Lidocaine, Restylane® Lyft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Restylane + LidocaineDevice
Restylane + Lidocaine is a HA gel generated by Streptococcus species of bacteria, chemically crosslinked with BDDE, stabilized and suspended in phosphate buffered saline at pH=7 and concentration of 20 mg/mL with 0.3% lidocaine. It is indicated for mid-to-deep dermal implantation for the correction of moderate to severe facial wrinkles and folds, such as NLFs.
Restylane® LyftDevice
Restylane® Lyft is a sterile gel of HA with lidocaine generated by Streptococcus species of bacteria, chemically cross-linked with BDDE (the cross linker), stabilized and suspended in phosphate buffered saline at pH=7 and concentration of 20 mg/mL. Lyft is intended to be used for facial tissue augmentation (Galderma Laboratories, 2014).
| Study group | Role | What they receive |
|---|---|---|
| Treatment A (right) B (left) | Experimental | Subjects will receive Restylane + Lidocaine and Restylane Lyft. One product will be randomized, per NLF. Receives: Device: Restylane + Lidocaine; Device: Restylane® Lyft |
| Treatment B (right) A (left) | Experimental | Subjects will receive Restylane + Lidocaine and Restylane Lyft. One product will be randomized, per NLF. Receives: Device: Restylane + Lidocaine; Device: Restylane® Lyft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin lifting capacity of two Restylane products, as assessed by ultrasound
The lifting capacity of two Restylane products (i.e., Restylane + Lidocaine and Restylane Lyft) will be assessed post-injection, using a skin ultrasound.
Measured: Baseline
Secondary outcomes (1)
Skin lifting capacity of two Restylane products, as assessed by ultrasouns
The lifting capacity of two Restylane products (i.e., Restylane + Lidocaine and Restylane Lyft) will be assessed post-injection, using a skin ultrasound.
Measured: Week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2019
- Study start13 Nov 2019
- Primary completion12 Dec 2019
- Study completion12 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wrinkles Such as Nasolabial FoldsStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erevna Innovations Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04174131
- Sponsor's protocol ID
- 2019-Gal-004NLF
- Status last verified
- Apr 2020
- First submitted
- 20 Nov 2019
- Last updated
- 10 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Split-face, Randomized, Comparative Trial on the Efficacy of Two Hyaluronic Acid Products (Restylane + Lidocaine and Restylane Lyft) for the Treatment of Nasolabial Folds
- ClinicalTrials.gov ID
- NCT04174131
- Acronym / sponsor ID
- 2019-Gal-004NLF
- Conditions
- Wrinkles Such as Nasolabial Folds
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Erevna Innovations Inc.University, hospital or other
- Study start
- 13 Nov 2019 (actual)
- Primary completion
- 12 Dec 2019 (actual)
- Study completion
- 12 Feb 2020 (actual)
- First posted
- 22 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to assess and compare the efficacy of two hyaluronic acid (HA) fillers on moderate, severe and extreme nasolabial folds (NLF).
Detailed description
Background
One of the most significant signs of aging is the appearance of deep lines that run from each side of the nose to the corners of the mouth [i.e., nasolabial folds (NLFs)]. These folds are defined by facial structures that support the buccal fat pad and separate the cheeks from the upper lip. The NLFs form due to volume shifts in the face, caused by a combination of fat descent and bone absorption, which results in sagging skin and hollowing.
Soft tissue augmentation can effectively restore the youthful, harmonious contours of the face. The most popular non-invasive treatment options for volume loss in the face include the use of hyaluronic acid (HA) fillers. Injections of HA for skin rejuvenation are one of the most common aesthetic treatments performed worldwide. Due to their effectiveness, safety, low immunogenicity (HA is a normal component of human skin) and reversibility with hyaluronidase, HA fillers are understandably a popular option for facial volume restoration.
Through recent advances in manufacturing technology, various types of HA fillers have been approved for the correction of facial wrinkles and folds, such as NLFs. Two such fillers, i) Restylane + Lidocaine and ii) Restylane Lyft, are well tolerated and provide significant improvement in this indication. These products contain the same amount of HA (i.e., 20mg/mL) and are manufactured using the same technology [i.e., non-animal stabilized hyaluronic acid (NASHATM)], but differ primarily in their particle size.
Small particle size HA (Restylane + Lidocaine): was the first non-animal stabilized HA-containing filler approved for use in the United States. Because of its particle size (i.e., 330-430 μM), Restylane + Lidocaine is referred to as small gel-particle HA (SGP-HA). NASHA small gel contains approximately 100,000 gel particles per mL.
Large particle size HA (Restylane Lyft): was approved in the United States in 2010 and is considered a large gel particle hyaluronic acid (LGP-HA). Restylane Lyft also contains the anesthetic lidocaine. NASHA large gel contains approximately 10,000 gel particles per mL.
The difference in gel size between the two products results in different viscosity and lifting capabilities, which is anticipated to affect treatment outcomes. While the comparative research is limited, a small number of clinical trials have compared the two products. For example, two randomized studies performed using US populations have shown equivalent safety and similar efficacy of Restylane + Lidocaine and Restylane Lyft, in subjects of all Fitzpatrick skin types; and one recent study found that both products exhibit similar safety and efficacy in a Chinese population. These three comparative studies found no significant differences in safety of LGP- and SGP-HA however, efficacy changes can occur due to the injection techniques and depth of injection used by the investigators.
This study is designed to assess and compare the efficacy of these two HA fillers on moderate, severe and extreme NLF, when using a modified technique. This modified technique will use a single puncture technique in each NLF, in comparison to others who have used a multi puncture, fanning or linear threading injection technique. For each NLF, a single bolus of product will be placed within the nasal pyriform aperture, on the periosteum. The location of the puncture will also vary from previous trials, in which injections were performed directly within the NLFs (to replace soft tissue volume). It is hypothesized that when these two products are used for replacing bone loss due to age-related resorption in the pyriform aperture, differences in efficacy will be observed that are not evident when they are used in soft tissue for volume augmentation. It is expected that while aesthetic outcomes and longevity of effect may be similar between the two products, the volumes required to achieve these same results will differ significantly, due to their different particle sizes.
Study Rationale
Larger HA gel particles result in better lifting capacities. Therefore, Restylane Lyft should display better efficacy in comparison to Restylane + Lidocaine when a "firm" product with a high lift capacity is required, such as when trying to replace or reshape bone. This is in contrast to replacing soft tissue volume, which was evaluated in earlier studies. However, as previous authors have reported, when these two products are used to replace soft tissue volume they both provide adequate lifting capabilities and thus result in similar efficacy levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment A (right) B (left) | Experimental | Device: Restylane + Lidocaine, Device: Restylane® LyftSubjects will receive Restylane + Lidocaine and Restylane Lyft. One product will be randomized, per NLF. |
| Treatment B (right) A (left) | Experimental | Device: Restylane + Lidocaine, Device: Restylane® LyftSubjects will receive Restylane + Lidocaine and Restylane Lyft. One product will be randomized, per NLF. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- At the time of consent, women between the ages of 30 and 75 years old;
- Indication for treatment of bilateral NLFs and wrinkles;
- Willingness to comply with study requirements;
- Provide written consent;
- Accepted the obligation not to receive any other facial procedures through the follow-up;
Key exclusion criteria (18 listed)
- Current pregnancy or lactation [sexually active women of childbearing age must agree to use medically acceptable methods of contraception for the duration of this study (e.g., oral contraceptives, condoms, intrauterine device, shot/injection, patch)];
- Hypersensitivity to hyaluronic acid or local anesthetics;
- Patients meeting any official Restylane contra-indications;
- Patients presenting with porphyria;
- Inability to comply with follow-up and abstain from facial injections during the study period;
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 |
|---|---|---|
| Restylane + LidocaineRestylane + Lidocaine is a HA gel generated by Streptococcus species of bacteria, chemically crosslinked with BDDE, stabilized and suspended in phosphate buffered saline at pH=7 and concentration of 20 mg/mL with 0.3% lidocaine. It is indicated for mid-to-deep dermal implantation for the correction of moderate to severe facial wrinkles and folds, such as NLFs. | Device | Treatment A (right) B (left), Treatment B (right) A (left) |
| Restylane® LyftRestylane® Lyft is a sterile gel of HA with lidocaine generated by Streptococcus species of bacteria, chemically cross-linked with BDDE (the cross linker), stabilized and suspended in phosphate buffered saline at pH=7 and concentration of 20 mg/mL. Lyft is intended to be used for facial tissue augmentation (Galderma Laboratories, 2014). | Device | Treatment A (right) B (left), Treatment B (right) A (left) |
Primary outcome
Skin lifting capacity of two Restylane products, as assessed by ultrasound
Time frame: Baseline
The lifting capacity of two Restylane products (i.e., Restylane + Lidocaine and Restylane Lyft) will be assessed post-injection, using a skin ultrasound.
1 secondary outcome
Skin lifting capacity of two Restylane products, as assessed by ultrasouns
Time frame: Week 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Restylane + Lidocaine and Restylane® Lyft in people with Wrinkles Such as Nasolabial Folds, run by Erevna Innovations Inc. at 1 site in Canada.
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 8 inclusion and 18 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 10 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Skin lifting capacity of two Restylane products, as assessed by ultrasound (time frame: Baseline). 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 10 Apr 2020.