Dermal FillerNCT05853224
An Interventional Study to Evaluate the Safety and Performance of Crosslinked Hyaluronic Acid Hydrogel
A study testing Crosslinked Hyaluronic Acid (CLHA) Hydrogel with and without Lidocaine in people with Dermal Filler and Volume Deficiency of the Midface, run by Biopolimeri Srl at 1 site in Italy.
Trial summary
The aim of this interventional, pre-market, double- blinded, controlled, two stages study is to evaluate the performance and safety of Crosslinked Hyaluronic Acid (CLHA) Hydrogel (with and without Lidocaine) for the Treatment of Soft Tissue Deficits. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Dermal Filler, Volume Deficiency of the Midface
- What is being tested?
- Crosslinked Hyaluronic Acid (CLHA) Hydrogel with and without Lidocaine
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteItaly
- Study dates
- 2 Apr 2022to 2 Dec 2023
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient Informed consent form (ICF) signed
- Female and male subjects aged 18-65 years and in good general health;
- Subjects with Soft Tissue Deficits of the face requiring midface volume restoration;
- Willingness to follow all study procedures, including attending all site visits, tests, and examinations;
- Agreeing to present at each study visit without makeup;
- Accepting to not change their habits regarding food, physical activity, make-up use, facial cosmetics, and cleansing products;
- Willingness to not undergo other procedures involving permanent and nonpermanent aesthetic correction (e.g. chemical peel, dermabrasion, ablative laser resurfacing), non-invasive skin-tightening, botulinum toxin injections, dermal filler injections, mesotherapy, or fat injections during the study period of 12 months;
- Willing to follow indications to not be exposed to make-up, excessive heat (sun, UV tanning sessions, or laser), and extreme temperatures (intense cold, sauna, hammam, etc.) after the treatment and until the complete absorption of swelling and reddening.
Who cannot join
- Presence of recurrent facial/labial herpes;
- Presence of tendon, bone, or muscular implants near the area of intervention;
- Subjects previously treated with fillers anywhere in the face or neck;
- Subjects who have undergone invasive face or neck surgery;
- Ongoing cutaneous allergies and history of hyper- or hypo-pigmentation in the mouth area, keloid formation, or hypertrophic scarring;
- Subjects with a known allergy or sensitivity to any component of the investigation products;
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- Subjects with a known allergy or sensitivity to any component of the anesthetic cream;
- Subjects with active autoimmune disease and subjects immunocompromised or immunosuppressed;
- Diabetes mellitus or uncontrolled systemic diseases (endocrine, hepatic renal, cardiac, pulmonary, neurological disorder);
- Problems with coagulation or anti-coagulating therapies in progress;
- Subjects with acute inflammatory process or infection, active herpes infection, or history of chronic or recurrent infections;
- Current treatment with substances which act on blood fluidity (eg. Aspirin, NSAIDs, Vitamin E), anti-inflammatory drugs, anti-histaminic, topic and systemic corticosteroids, narcotic, antidepressant, immunosuppressive drugs (with the except of contraceptive or hormonal treatment starting more than 1 year ago), drugs able to influence the test results in the investigator opinion;
- Known drug and/or alcohol abuse;
- Mental incapacity that precludes adequate understanding or cooperation;
- Any previous permanent and nonpermanent cutaneous treatment for aesthetic correction e.g. chemical peel, dermabrasion, ablative laser resurfacing, non-invasive skin-tightening, botulinum toxin injections, mesotherapy, or fat injections within 6 months prior to study inclusion;
- Pregnancy or breastfeeding;
- COVID-19 vaccination within one month prior to study inclusion;
- Participation in another investigational study within 1 month prior to study inclusion.
Trial locations and contacts
1 site in 1 country.
Piera Angela Ramires, Dr. contact
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Universitario Campus Bio-medico
Roma, 00128
Paolo Persichetti, Prof., 06 225411 ext. +39, comitato.etico@policlinicocampus.it
About this study
Official title: An Interventional, Pre-Market, Double-Blinded, Controlled, Two Stages Study to Evaluate the Safety and Performance of Crosslinked Hyaluronic Acid Hydrogel (With and Without Lidocaine) for the Treatment of Soft Tissue Deficits
The aim of this interventional, pre-market, double- blinded, controlled, two stages study is to evaluate the performance and safety of Crosslinked Hyaluronic Acid (CLHA) Hydrogel (with and without Lidocaine) for the Treatment of Soft Tissue Deficits.
Read the detailed description
The performance of Crosslinked Hyaluronic Acid Hydrogel (with and without Lidocaine), for the correction of congenital and acquired deficits of soft tissue, will be evaluated using the change from baseline to V3 in the Wrinkle Severity Rating Scale (WSRS) for 26 mg/ml and 18mg/ml CLHA formulations and in the Lip Fullness Scale (LFS) for 20 mg/ml CLHA formulation.
The duration of the aesthetic effect of Crosslinked Hyaluronic Acid Hydrogel (with and without Lidocaine) for the correction of NLFs, perioral wrinkles and lips augmentation, will be assessed using the mean of the absolute change from baseline to each follow up visit in WSRS and LFS score. WSRS and LFS will be assessed by the evaluating investigator who will be different by the treating investigator.
The aesthetic appearance of the Crosslinked Hyaluronic Acid Hydrogel (with and without Lidocaine) will be assessed using the Global Aesthetic Improvement Scale (GAIS) at each visit. The GAIS will be completed by both the subjects and the evaluating investigators; The volume of material required to achieve an optimal correction result will be assessed at baseline and at optional touch up; The pain intensity after injection of Crosslinked Hyaluronic Acid Hydrogel (with and without Lidocaine) will be assessed using a Numerical Rating Scale (NRS) 2 hours after the injection; The patient satisfaction and the usability of Crosslinked Hyaluronic Acid Hydrogel (with and without Lidocaine) will be evaluated with a specific questionnaire, completed by the Principal Investigator.
The Safety of Crosslinked Hyaluronic Acid Hydrogel (with and without Lidocaine) will be assessed by facial examination and vital signs over the duration of the study. Adverse events and serious adverse events will be collected at each planned visit into a diary dispensed to patients.
- Conditions
- Dermal Filler, Volume Deficiency of the Midface
- Being tested
- Crosslinked Hyaluronic Acid (CLHA) Hydrogel with and without Lidocaine
- Keywords
- Volume Loss, Aging, Aesthetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Crosslinked Hyaluronic Acid (CLHA) Hydrogel with and without LidocaineDevice
The injection should be performed at variable depth of the skin (dermal or subdermal), depending on the area to be treated and on the product variants, in accordance to the IFU of the IPs
| Study group | Role | What they receive |
|---|---|---|
| Crosslinked Hyaluronic Acid (CLHA) Hydrogel with Lidocaine | Experimental | Patients were treated, on one side of the face with crosslinked Hyaluronic Acid Hydrogel with 0.3% lidocaine hydrochloride. Receives: Device: Crosslinked Hyaluronic Acid (CLHA) Hydrogel with and without Lidocaine |
| Crosslinked Hyaluronic Acid (CLHA) Hydrogel without Lidocaine | Experimental | Patients were treated, on the other side of the face with crosslinked Hyaluronic Acid Hydrogel without lidocaine hydrochloride. Receives: Device: Crosslinked Hyaluronic Acid (CLHA) Hydrogel with and without Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the CLHA performance in the nasolabial folds
The performance of Crosslinked Hyaluronic Acid Hydrogel (with and without Lidocaine), for the correction of congenital and acquired deficits of soft tissue in the Nasolabial folds, will be evaluated using the change from baseline to V3 in the Wrinkle Severity Rating Scale (WSRS) for 26 mg/ml CLHA formulation. WSRS is a validated 5-point scale (1 = Absent, 5 = Extreme)
Measured: 6 months
Evaluation of the CLHA performance in the perioral lines
The performance of Crosslinked Hyaluronic Acid Hydrogel (with and without Lidocaine), for the correction of congenital and acquired deficits of soft tissue in the perioral lines, will be evaluated using the change from baseline to V3 in the Wrinkle Severity Rating Scale (WSRS) for 18mg/ml CLHA formulations. WSRS is a validated 5-point scale (1 = Absent, 5 = Extreme)
Measured: 6 months
Evaluation of the CLHA performance in the lips
The performance of Crosslinked Hyaluronic Acid Hydrogel (with and without Lidocaine), for the correction of congenital and acquired deficits of soft tissue in the lips, will be evaluated using the change from baseline to V3 in the Lip Fullness Scale (LFS) for 20 mg/ml CLHA formulation. LFS is a validated 5-point scale (0 = Very Thin, 4 = Full).
Measured: 6 months
Secondary outcomes (7)
Evaluation of the restoring the physiological volumes of the face in the nasolabial folds
The performance of Crosslinked Hyaluronic Acid Hydrogel (with and without Lidocaine) used as intended for restoring the physiological volumes of the face n the nasolabial folds, will be assessed using the change, from baseline to each visit, in the Wrinkle Severity Rating Scale (WSRS) for the 26 mg/ml CLHA formulations. WSRS will be assessed by the evaluating investigator who will be different from the treating investigator. WSRS is a validated 5-point scale (1 = Absent, 5 = Extreme).
Measured: 6 months
Evaluation of the restoring the physiological volumes of the face in the perioral lines
The performance of Crosslinked Hyaluronic Acid Hydrogel (with and without Lidocaine) used as intended for restoring the physiological volumes of the face in the perioral lines, will be assessed using the change, from baseline to each visit, in the Wrinkle Severity Rating Scale (WSRS) for the 18mg/ml CLHA formulations. WSRS will be assessed by the evaluating investigator who will be different from the treating investigator. WSRS is a validated 5-point scale (1 = Absent, 5 = Extreme).
Measured: 6 months
Evaluation of the restoring the physiological volumes of the face in the lips
The performance of Crosslinked Hyaluronic Acid Hydrogel (with and without Lidocaine) used as intended for restoring the physiological volumes of the lips, will be assessed using the change, from baseline to each visit in the Lip Fullness Scale (LFS), for 20 mg/ml CLHA. LFS will be assessed by the evaluating investigator who will be different from the treating investigator. LFS is a validated 5-point scale (0 = Very Thin, 4 = Full).
Measured: 6 months
Evaluation of the duration of the aesthetic effect on the nasolabial folds
The duration of the aesthetic effect of Crosslinked Hyaluronic Acid Hydrogel (with and without Lidocaine) for the correction of NLFs will be assessed using the mean of the absolute change from baseline to each follow up visit in WSRS score. WSRS awill be assessed by the evaluating investigator who will be different by the treating investigator. WSRS is a validated 5-point scale (1 = Absent, 5 = Extreme).
Measured: 6 months
Evaluation of the duration of the aesthetic effect on the perioral lines
The duration of the aesthetic effect of Crosslinked Hyaluronic Acid Hydrogel (with and without Lidocaine) for the correction of perioral lines, will be assessed using the mean of the absolute change from baseline to each follow up visit in WSRS score. WSRS will be assessed by the evaluating investigator who will be different by the treating investigator. WSRS is a validated 5-point scale (1 = Absent, 5 = Extreme).
Measured: 6 months
Evaluation of the duration of the aesthetic effect on the lips
The duration of the aesthetic effect of Crosslinked Hyaluronic Acid Hydrogel (with and without Lidocaine) for the correction of lips augmentation, will be assessed using the mean of the absolute change from baseline to each follow up visit in LFS score. LFS will be assessed by the evaluating investigator who will be different by the treating investigator. LFS is a validated 5-point scale (0 = Very Thin, 4 = Full).
Measured: 6 months
Evaluation of the Global Aesthetic Improvement
To evaluate the performance of Crosslinked Hyaluronic Acid Hydrogel (with and without Lidocaine) to improve aesthetic appearance, the Global Aesthetic Improvement Scale (GAIS) will be assessed at each visit. The GAIS will be completed by both the subjects and the evaluating investigators. The GAIS is a validated 5-point scale (1 = extremely improved, 5 worse).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2023
- Study start2 Apr 2022
- Primary completion2 Dec 2023 (estimated)
- Study completion2 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dermal FillerStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Each Subject, after signing the Informed Consent (ICF), will enter into a screening phase during which the baseline tests will be conducted. At baseline visit (V0), according to the Instruction For Use (IFU) and to Investigator's judgment based on the patient's starting clinical situation, the subject will be treated with one of the three variants of Crosslinked Hyaluronic Acid (CLHA) Hydrogel as indicated below: * CLHA Hydrogel 26 mg/ml (with and without lidocaine) will be injected in the hypodermis of the nasolabial folds (NLFs); * CLHA Hydrogel 20 mg/ml (with and without lidocaine) will be injected in the lips mucosa/submucosa; * CLHA Hydrogel 18 mg/ml (with and without lidocaine) will be injected in the superficial dermis of the perioral lines.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biopolimeri Srl
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- 1Med
- Responsible party
- Sponsor
- Investigators
- Paolo Persichetti, Prof., Principal investigator, Fondazione Policlinico Universitario Campus Bio-Medico Roma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05853224
- Sponsor's protocol ID
- CS-14-01
- Status last verified
- May 2023
- First submitted
- 28 Mar 2023
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Interventional, Pre-Market, Double-Blinded, Controlled, Two Stages Study to Evaluate the Safety and Performance of Crosslinked Hyaluronic Acid Hydrogel (With and Without Lidocaine) for the Treatment of Soft Tissue Deficits
- ClinicalTrials.gov ID
- NCT05853224
- Acronym / sponsor ID
- CS-14-01
- Conditions
- Dermal Filler, Volume Deficiency of the Midface
- Keywords
- Volume Loss, Aging, Aesthetic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Biopolimeri SrlIndustry (pharma, biotech, devices)
- Collaborators
- 1Med
- Study start
- 2 Apr 2022 (actual)
- Primary completion
- 2 Dec 2023 (estimated)
- Study completion
- 2 Dec 2023 (estimated)
- First posted
- 10 May 2023 (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.
The aim of this interventional, pre-market, double- blinded, controlled, two stages study is to evaluate the performance and safety of Crosslinked Hyaluronic Acid (CLHA) Hydrogel (with and without Lidocaine) for the Treatment of Soft Tissue Deficits.
Detailed description
The performance of Crosslinked Hyaluronic Acid Hydrogel (with and without Lidocaine), for the correction of congenital and acquired deficits of soft tissue, will be evaluated using the change from baseline to V3 in the Wrinkle Severity Rating Scale (WSRS) for 26 mg/ml and 18mg/ml CLHA formulations and in the Lip Fullness Scale (LFS) for 20 mg/ml CLHA formulation.
The duration of the aesthetic effect of Crosslinked Hyaluronic Acid Hydrogel (with and without Lidocaine) for the correction of NLFs, perioral wrinkles and lips augmentation, will be assessed using the mean of the absolute change from baseline to each follow up visit in WSRS and LFS score. WSRS and LFS will be assessed by the evaluating investigator who will be different by the treating investigator.
The aesthetic appearance of the Crosslinked Hyaluronic Acid Hydrogel (with and without Lidocaine) will be assessed using the Global Aesthetic Improvement Scale (GAIS) at each visit. The GAIS will be completed by both the subjects and the evaluating investigators; The volume of material required to achieve an optimal correction result will be assessed at baseline and at optional touch up; The pain intensity after injection of Crosslinked Hyaluronic Acid Hydrogel (with and without Lidocaine) will be assessed using a Numerical Rating Scale (NRS) 2 hours after the injection; The patient satisfaction and the usability of Crosslinked Hyaluronic Acid Hydrogel (with and without Lidocaine) will be evaluated with a specific questionnaire, completed by the Principal Investigator.
The Safety of Crosslinked Hyaluronic Acid Hydrogel (with and without Lidocaine) will be assessed by facial examination and vital signs over the duration of the study. Adverse events and serious adverse events will be collected at each planned visit into a diary dispensed to patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Each Subject, after signing the Informed Consent (ICF), will enter into a screening phase during which the baseline tests will be conducted. At baseline visit (V0), according to the Instruction For Use (IFU) and to Investigator's judgment based on the patient's starting clinical situation, the subject will be treated with one of the three variants of Crosslinked Hyaluronic Acid (CLHA) Hydrogel as indicated below: * CLHA Hydrogel 26 mg/ml (with and without lidocaine) will be injected in the hypodermis of the nasolabial folds (NLFs); * CLHA Hydrogel 20 mg/ml (with and without lidocaine) will be injected in the lips mucosa/submucosa; * CLHA Hydrogel 18 mg/ml (with and without lidocaine) will be injected in the superficial dermis of the perioral lines.
| Arm | Type | Receives |
|---|---|---|
| Crosslinked Hyaluronic Acid (CLHA) Hydrogel with Lidocaine | Experimental | Device: Crosslinked Hyaluronic Acid (CLHA) Hydrogel with and without LidocainePatients were treated, on one side of the face with crosslinked Hyaluronic Acid Hydrogel with 0.3% lidocaine hydrochloride. |
| Crosslinked Hyaluronic Acid (CLHA) Hydrogel without Lidocaine | Experimental | Device: Crosslinked Hyaluronic Acid (CLHA) Hydrogel with and without LidocainePatients were treated, on the other side of the face with crosslinked Hyaluronic Acid Hydrogel without lidocaine hydrochloride. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient Informed consent form (ICF) signed
- Female and male subjects aged 18-65 years and in good general health;
- Subjects with Soft Tissue Deficits of the face requiring midface volume restoration;
- Willingness to follow all study procedures, including attending all site visits, tests, and examinations;
- Agreeing to present at each study visit without makeup;
Key exclusion criteria (18 listed)
- Presence of recurrent facial/labial herpes;
- Presence of tendon, bone, or muscular implants near the area of intervention;
- Subjects previously treated with fillers anywhere in the face or neck;
- Subjects who have undergone invasive face or neck surgery;
- Ongoing cutaneous allergies and history of hyper- or hypo-pigmentation in the mouth area, keloid formation, or hypertrophic scarring;
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 |
|---|---|---|
| Crosslinked Hyaluronic Acid (CLHA) Hydrogel with and without LidocaineThe injection should be performed at variable depth of the skin (dermal or subdermal), depending on the area to be treated and on the product variants, in accordance to the IFU of the IPs | Device | Crosslinked Hyaluronic Acid (CLHA) Hydrogel with Lidocaine, Crosslinked Hyaluronic Acid (CLHA) Hydrogel without Lidocaine |
Primary outcome
Evaluation of the CLHA performance in the nasolabial folds
Time frame: 6 months
The performance of Crosslinked Hyaluronic Acid Hydrogel (with and without Lidocaine), for the correction of congenital and acquired deficits of soft tissue in the Nasolabial folds, will be evaluated using the change from baseline to V3 in the Wrinkle Severity Rating Scale (WSRS) for 26 mg/ml CLHA formulation. WSRS is a validated 5-point scale (1 = Absent, 5 = Extreme)
Evaluation of the CLHA performance in the perioral lines
Time frame: 6 months
The performance of Crosslinked Hyaluronic Acid Hydrogel (with and without Lidocaine), for the correction of congenital and acquired deficits of soft tissue in the perioral lines, will be evaluated using the change from baseline to V3 in the Wrinkle Severity Rating Scale (WSRS) for 18mg/ml CLHA formulations. WSRS is a validated 5-point scale (1 = Absent, 5 = Extreme)
Evaluation of the CLHA performance in the lips
Time frame: 6 months
The performance of Crosslinked Hyaluronic Acid Hydrogel (with and without Lidocaine), for the correction of congenital and acquired deficits of soft tissue in the lips, will be evaluated using the change from baseline to V3 in the Lip Fullness Scale (LFS) for 20 mg/ml CLHA formulation. LFS is a validated 5-point scale (0 = Very Thin, 4 = Full).
7 secondary outcomes
Evaluation of the restoring the physiological volumes of the face in the nasolabial folds
Time frame: 6 months
Evaluation of the restoring the physiological volumes of the face in the perioral lines
Time frame: 6 months
Evaluation of the restoring the physiological volumes of the face in the lips
Time frame: 6 months
Evaluation of the duration of the aesthetic effect on the nasolabial folds
Time frame: 6 months
Evaluation of the duration of the aesthetic effect on the perioral lines
Time frame: 6 months
Evaluation of the duration of the aesthetic effect on the lips
Time frame: 6 months
Evaluation of the Global Aesthetic Improvement
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- Individual participant dataSharing planned: No
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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.
Piera Angela Ramires, Dr. contact
Paolo Persichetti, Prof. principal investigator
Fondazione Policlinico Universitario Campus Bio-Medico Roma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Crosslinked Hyaluronic Acid (CLHA) Hydrogel with and without Lidocaine in people with Dermal Filler and Volume Deficiency of the Midface, run by Biopolimeri Srl at 1 site in Italy.
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: status not confirmed, as of the sponsor's last update on 10 May 2023. 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 Italy. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vincenzo De Benedictis, Dr. (3494263425 ext. +39, v.debenedictis@biopolimerisrl.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the CLHA performance in the nasolabial folds (time frame: 6 months). The study lists 3 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 10 May 2023; AzTrials last refreshed its copy on 29 Oct 2026.