Skin FoldsNCT05450380
Clinical Investigation to Assess Safety and Performance of Dermal Filler of Hyaluronic Acid
A study testing LIFT001 in people with Skin Folds and Wrinkle, run by Mesoestetic Pharma Group S.L. at 2 sites in Spain.
Trial summary
The objective of this clinical investigation is to assess the safety and performance of dermal filler of hyaluronic acid to provide firmness and counteract sagging for the correction of deep wrinkles and imperfections in the lower two thirds of the face at 2 months post-treatment. Read more about this study
- Who is it for?
- Ages 45 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Folds, Wrinkle
- What is being tested?
- LIFT001
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesSpain
- Study dates
- 2 Aug 2022to 31 Jan 2024
- 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 45 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject who had provided written informed consent form.
- Adult male or female subjects between 45 and 70 years old.
- Subject with moderate (2) or higher score in the Wrinkle Severity Rating Scale (WSRS) in the lower two thirds, and in at least one of the two sides of the face, assessed at baseline by the treating investigator.
- Subject must be willing to abstain from any other facial invasive treatment (plastic surgery, implants, peelings) in the lower two thirds of the face during the clinical investigation period.
Who cannot join
- History of severe or multiple allergies, including allergy or hypersensitivity to injectable hyaluronic acid gel, lidocaine, anesthetics, or nerve-blocking agents or any of the components of product.
- Any disease at baseline that results in changes of facial contour or facial edema.
- Active skin disease or inflammation on or near the injection area at baseline that could interfere with the clinical investigation injections or assessments.
- History of connective tissue diseases.
- Soft tissue augmentation in the previous 6 months with bovine collagen, in the previous 12 months with porcine or human collagen, or in the previous 18 months with hyaluronic acid or hydroxyapatite.
- Any aesthetic treatment/procedure on the face in the previous 6 months that may interfere with study injections and/or study assessments.
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- Subjects who have received permanent facial implants within the previous 36 months.
- Presence of any condition, which in the opinion of the investigator, made the subject unable to complete the clinical investigation per protocol.
- Subjects who are currently participating in another clinical investigation which may interfere with this clinical investigation.
- Pregnant or nursing subjects, and subjects who plan pregnancy during the clinical investigation period.
- Subjects undergoing restrictive nutritional regimens.
- Subjects who practice facial impact sports, such as boxing, karate, taekwondo and other similar sports.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Centro Dermatologico Internacional - Cdi
Madrid, CAM, 28001
Hospital Ruber Internacional
Madrid, CAM, 28034
About this study
The objective of this clinical investigation is to assess the safety and performance of dermal filler of hyaluronic acid to provide firmness and counteract sagging for the correction of deep wrinkles and imperfections in the lower two thirds of the face at 2 months post-treatment.
Read the detailed description
The primary endpoint is to assess the safety of dermal filler of hyaluronic acid by occurrence of Treatment-Related Adverse Events (TRAEs) and Serious Adverse Events (SAEs) through 2 months post-treatment. Furthermore, the performance of the device will also be assessed as the aesthetical outcome measured by the Global Aesthetic Improvement Scale (GAIS), Wrinkle Severity Rating Scale (WSRS), and 2D images of subjects' faces at 2 months post-treatment.The secondary endpoints are the following:
Secondary Safety Endpoint
- To assess the safety of dermal filler of hyaluronic acid by occurrence of Treatment-related Adverse Events (TRAEs) and Serious Adverse Events (SAEs) through 6-, 9-, and 12-months post-treatment.
- To assess the safety of dermal filler of hyaluronic acid by occurrence of all AEs through 2-, 6-, 9-, and 12-months post-treatment.
Secondary Performance Endpoint
- To evaluate the performance of dermal filler of hyaluronic acid at 6-, 9- and 12-months post-treatment, assessed as the aesthetical outcome measured by the Global Aesthetic Improvement Scale (GAIS)
- Assessment of dermal filler of hyaluronic acid performance of mesofiller® Lift at 6-, 9- and 12-months post-treatment using the Wrinkle Severity Rating Scale (WSRS)
- Assessment of dermal filler of hyaluronic acid performance of dermal filler of hyaluronic acid at 6-, 9- and 12-months post-treatment using 2D images of subjects' faces
- Assessment of dermal filler of hyaluronic acid performance of dermal filler of hyaluronic acidt at 6-, 9- and 12-months post-treatment through satisfaction surveys related to the subject's appearance.
- Conditions
- Skin Folds, Wrinkle
- Being tested
- LIFT001
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LIFT001Device
The dermal filler of hyaluronic acid LIFT001 is applied to the facial area to provide firmness and counteract sagging for the correction of deep wrinkles and imperfections of face.
The dermal filler of hyaluronic acid LIFT001 is applied to the facial area to provide firmness and counteract sagging for the correction of deep wrinkles and imperfections of face.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: LIFT001 | Experimental | LIFT001 is composed by sodium hyaluronate at concentration of 2,5% (25 mg/ml) with 1,4-Butanediol diglycidyl ether (BDDE) acting as a cross-linking agent, in aqueous solution at physiological pH. The filler of 1ml is administered once or twice depending on the individual necessity.
The dermal filler of hyaluronic acid LIFT001 is applied to the facial area to provide firmness and counteract sagging for the correction of deep wrinkles and imperfections of face. Receives: Device: LIFT001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of occurrence of Treatment-Related Adverse Events (TRAEs) and Serious Adverse Events (SAEs) of device LIFT001 at 2 months time
The primary endpoint is to assess the safety of product LIFT001 by occurrence of Treatment-Related Adverse Events (TRAEs) and Serious Adverse Events (SAEs) through 2 months post-treatment.
Measured: 2 MONTHS
Performance of device LIFT001 at 2 months time - GAIS scale
The performance of the device LIFT001 will also be assessed as the aesthetical outcome measured by:
- Global Aesthetic Improvement Scale (GAIS)
Score Grade Description 7 Very Much Improved Very marked improvement in appearance to
1 Very Much Worse The appearance is very much worse than the original condition
Measured: 2 MONTHS
Performance of device LIFT001 at 2 months time - WSRS scale
The performance of the device LIFT001 will also be assessed as the aesthetical outcome measured by:
- Wrinkle Severity Rating Scale (WSRS)
Score Severity descriptions 4 Extreme Very deep wrinkle, redundant fold (overlapping skin) 0 None No wrinkle
Measured: 2 MONTHS
Performance of device LIFT001 at 2 months time - 2D images
The performance of the device LIFT001 will also be assessed as the aesthetical outcome measured by:
- 2D images of subjects' faces at 2 months post-treatment.
Measured: 2 MONTHS
Secondary outcomes (4)
Evaluation of occurrence of Treatment-Related Adverse Events (TRAEs) and Serious Adverse Events (SAEs) of device LIFT001 at 6, 9 and 12 months time
- To assess the safety of LIFT001 by occurrence of Treatment-related Adverse Events (TRAEs) and Serious Adverse Events (SAEs) through 6-, 9-, and 12-months post-treatment.
- To assess the safety of LIFT001 by occurrence of all AEs through 2- , 6-, 9-, and 12-months post-treatment.
Measured: 12 MONTHS
Performance of device LIFT001 at 12 months time - GAIS scale
To evaluate the performance of LIFT001 at 6-, 9- and 12-months post-treatment, assessed as the aesthetical outcome measured by:
- Global Aesthetic Improvement Scale (GAIS) Score Grade Description 7 Very Much Improved Very marked improvement in appearance to
1 Very Much Worse The appearance is very much worse than the original condition
Measured: 12 months
Performance of device LIFT001 at 12 months time - WSRS scale
To evaluate the performance of LIFT001 at 6-, 9- and 12-months post-treatment, assessed as the aesthetical outcome measured by:
- Wrinkle Severity Rating Scale (WSRS) Score Severity descriptions 4 Extreme Very deep wrinkle, redundant fold (overlapping skin) 0 None No wrinkle
Measured: 12 months
Performance of device LIFT001 at 12 months time - 2D images
To evaluate the performance of LIFT001 at 6-, 9- and 12-months post-treatment, assessed as the aesthetical outcome measured by:
- 2D images of subjects' faces at 6, 9 and 12 months post-treatment.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2022
- Study start2 Aug 2022
- Primary completion31 Jul 2023
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mesoestetic Pharma Group S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05450380
- Sponsor's protocol ID
- CIP-LIFT001-042022
- Status last verified
- Feb 2024
- First submitted
- 15 Jun 2022
- Last updated
- 5 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation to Assess Safety and Performance of Dermal Filler of Hyaluronic Acid
- ClinicalTrials.gov ID
- NCT05450380
- Acronym / sponsor ID
- CIP-LIFT001-042022
- Conditions
- Skin Folds, Wrinkle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Mesoestetic Pharma Group S.L.Industry (pharma, biotech, devices)
- Study start
- 2 Aug 2022 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 8 Jul 2022 (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 objective of this clinical investigation is to assess the safety and performance of dermal filler of hyaluronic acid to provide firmness and counteract sagging for the correction of deep wrinkles and imperfections in the lower two thirds of the face at 2 months post-treatment.
Detailed description
The primary endpoint is to assess the safety of dermal filler of hyaluronic acid by occurrence of Treatment-Related Adverse Events (TRAEs) and Serious Adverse Events (SAEs) through 2 months post-treatment. Furthermore, the performance of the device will also be assessed as the aesthetical outcome measured by the Global Aesthetic Improvement Scale (GAIS), Wrinkle Severity Rating Scale (WSRS), and 2D images of subjects' faces at 2 months post-treatment.The secondary endpoints are the following:
Secondary Safety Endpoint
- To assess the safety of dermal filler of hyaluronic acid by occurrence of Treatment-related Adverse Events (TRAEs) and Serious Adverse Events (SAEs) through 6-, 9-, and 12-months post-treatment.
- To assess the safety of dermal filler of hyaluronic acid by occurrence of all AEs through 2-, 6-, 9-, and 12-months post-treatment.
Secondary Performance Endpoint
- To evaluate the performance of dermal filler of hyaluronic acid at 6-, 9- and 12-months post-treatment, assessed as the aesthetical outcome measured by the Global Aesthetic Improvement Scale (GAIS)
- Assessment of dermal filler of hyaluronic acid performance of mesofiller® Lift at 6-, 9- and 12-months post-treatment using the Wrinkle Severity Rating Scale (WSRS)
- Assessment of dermal filler of hyaluronic acid performance of dermal filler of hyaluronic acid at 6-, 9- and 12-months post-treatment using 2D images of subjects' faces
- Assessment of dermal filler of hyaluronic acid performance of dermal filler of hyaluronic acidt at 6-, 9- and 12-months post-treatment through satisfaction surveys related to the subject's appearance.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: LIFT001 | Experimental | Device: LIFT001LIFT001 is composed by sodium hyaluronate at concentration of 2,5% (25 mg/ml) with 1,4-Butanediol diglycidyl ether (BDDE) acting as a cross-linking agent, in aqueous solution at physiological pH. The filler of 1ml is administered once or twice depending on the individual necessity. The dermal filler of hyaluronic acid LIFT001 is applied to the facial area to provide firmness and counteract sagging for the correction of deep wrinkles and imperfections of face. |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject who had provided written informed consent form.
- Adult male or female subjects between 45 and 70 years old.
- Subject with moderate (2) or higher score in the Wrinkle Severity Rating Scale (WSRS) in the lower two thirds, and in at least one of the two sides of the face, assessed at baseline by the treating investigator.
- Subject must be willing to abstain from any other facial invasive treatment (plastic surgery, implants, peelings) in the lower two thirds of the face during the clinical investigation period.
Key exclusion criteria (12 listed)
- History of severe or multiple allergies, including allergy or hypersensitivity to injectable hyaluronic acid gel, lidocaine, anesthetics, or nerve-blocking agents or any of the components of product.
- Any disease at baseline that results in changes of facial contour or facial edema.
- Active skin disease or inflammation on or near the injection area at baseline that could interfere with the clinical investigation injections or assessments.
- History of connective tissue diseases.
- Soft tissue augmentation in the previous 6 months with bovine collagen, in the previous 12 months with porcine or human collagen, or in the previous 18 months with hyaluronic acid or hydroxyapatite.
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 |
|---|---|---|
| LIFT001The dermal filler of hyaluronic acid LIFT001 is applied to the facial area to provide firmness and counteract sagging for the correction of deep wrinkles and imperfections of face. The dermal filler of hyaluronic acid LIFT001 is applied to the facial area to provide firmness and counteract sagging for the correction of deep wrinkles and imperfections of face. | Device | Experimental: LIFT001 |
Primary outcome
Evaluation of occurrence of Treatment-Related Adverse Events (TRAEs) and Serious Adverse Events (SAEs) of device LIFT001 at 2 months time
Time frame: 2 MONTHS
The primary endpoint is to assess the safety of product LIFT001 by occurrence of Treatment-Related Adverse Events (TRAEs) and Serious Adverse Events (SAEs) through 2 months post-treatment.
Performance of device LIFT001 at 2 months time - GAIS scale
Time frame: 2 MONTHS
The performance of the device LIFT001 will also be assessed as the aesthetical outcome measured by: * Global Aesthetic Improvement Scale (GAIS) Score Grade Description 7 Very Much Improved Very marked improvement in appearance to 1 Very Much Worse The appearance is very much worse than the original condition
Performance of device LIFT001 at 2 months time - WSRS scale
Time frame: 2 MONTHS
The performance of the device LIFT001 will also be assessed as the aesthetical outcome measured by: - Wrinkle Severity Rating Scale (WSRS) Score Severity descriptions 4 Extreme Very deep wrinkle, redundant fold (overlapping skin) 0 None No wrinkle
Performance of device LIFT001 at 2 months time - 2D images
Time frame: 2 MONTHS
The performance of the device LIFT001 will also be assessed as the aesthetical outcome measured by: - 2D images of subjects' faces at 2 months post-treatment.
4 secondary outcomes
Evaluation of occurrence of Treatment-Related Adverse Events (TRAEs) and Serious Adverse Events (SAEs) of device LIFT001 at 6, 9 and 12 months time
Time frame: 12 MONTHS
Performance of device LIFT001 at 12 months time - GAIS scale
Time frame: 12 months
Performance of device LIFT001 at 12 months time - WSRS scale
Time frame: 12 months
Performance of device LIFT001 at 12 months time - 2D images
Time frame: 12 months
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 5 Feb 2024.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LIFT001 in people with Skin Folds and Wrinkle, run by Mesoestetic Pharma Group S.L. at 2 sites in Spain.
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 4 inclusion and 12 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 5 Feb 2024. 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 Spain. 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?
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?
Evaluation of occurrence of Treatment-Related Adverse Events (TRAEs) and Serious Adverse Events (SAEs) of device LIFT001 at 2 months time (time frame: 2 MONTHS). The study lists 4 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 5 Feb 2024.