WrinklePLLANCT05215054
Clinical Study for the Evaluation of the Safety and Effectiveness of Use of a Poly-L Lactic Acid Injectable Filler for the Aesthetic Treatment of Nasolabial Folds
A study testing Gana V® and Sculptra® in people with Wrinkle, run by GCS Co., Ltd at 1 site in France.
Trial summary
The purpose of this study is to assess the effectiveness and safety of Gana V, a Poly L-lactic acid filler for the aesthetic treatment of nasolabial folds, in comparison with Sculptra. Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Wrinkle
- What is being tested?
- Gana V® and Sculptra®
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteFrance
- Study dates
- 7 Mar 2022to 7 May 2024
- Phase
- Interventional
- 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 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject with moderate to severe nasolabial folds as determined by a Wrinkle Severity Rating Scale (WSRS) score of 3 or 4 on both folds at the pre-treatment evaluation.
- Subject wiling to abstain from other facial procedures (i.e., dermal fillers, toxin treatments, laser, microdermal abrasion, chemical peels, non-invasive skin-tightening) during the whole study period.
- Subject, psychologically able to understand the study related information and to give a written informed consent.
- Subject having given freely and expressly his/her informed consent.
- Subject willing to have photographs of the face taken.
- Subject affiliated to a health social security system.
- Female of childbearing potential should use a contraceptive regimen recognized as effective since at least 12 weeks before screening visit and during the whole study period.
Who cannot join
- Pregnant or nursing woman or planning a pregnancy during the study.
- Subject with a scar, moles, pigment disorders or anything on the face which might interfere with the evaluation.
- Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship.
- Subject in a social or sanitary establishment
- Subject participation to another research on human beings or who is in an exclusion period of one.
- Subject having received 4500 euros indemnities for participation in research involving human beings in the 12 previous months, including participation in the present study.
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- Subject suspected to be non-compliant according to the investigator's judgment.
- Subject suffering from a severe or progressive disease or any other pathology that may interfere with the evaluation of the study results.
- Subject with known history of or suffering from autoimmune disease and/or immune deficiency.
- Subject suffering from inflammatory and/or infectious cutaneous disorders in or near the studied zones (e.g. acne, mycosis, papilloma, chronic eczema, atopic dermatitis…). Subject with labial herpes in the last 2 years is not eligible even if asymptomatic at time of screening visit.
- Subject with an abscess, unhealed wound, or a cancerous or precancerous lesion on the studied zone.
- Subject prone to develop inflammatory skin conditions or having tendency to bleeding disorders.
- Subject with a tendency to develop keloids or hypertrophic scarring.
- Subject having history of allergy or anaphylactic shock including hypersensitivity to Poly-l-lactic acid, to lidocaine or to one of the components of the tested devices or antiseptic solution.
- Subject having received treatment with a laser, a dermabrasion, a surgery, a deep chemical peeling or other ablative procedure on the face within the past 12 months prior to screening visit.
- Subject having received injection with a resorbable filling product in the face area within the past 12 months prior to screening visit.
- Subject having received at any time injection with a slowly resorbable filling product (polylactic acid, calcium hydroxyapatite, combinations of hyaluronic acid (HA) and hypromellose, HA and dextran microbeads or HA and TriCalcium Phosphate (TCP), …) or with a non-resorbable filling product (polyacrylamide, silicone, combination of methacrylic polymers and collagen, polymer particles, …) on the face.
- Subject having received at any time a treatment with tensor threads on the face.
- Subject having started or changed her oral contraceptive or any other hormonal treatment during 12 weeks prior to screening visit.
- Subject using medication such as aspirin, nonsteroidal anti-inflammatory drugs (NSAID) (ibuprofen, naproxen, …), antiplatelet agents, anticoagulants or other substances known to prolong bleeding time within 1 week prior to injection visits.
- Subject undergoing a topical treatment on the test area or a systemic treatment:
- Antihistamines during the 2 weeks prior to screening visit.
- Immunosuppressors and/or corticoids during the 4 weeks prior to screening visit.
- Retinoids during the 6 months prior to screening visit.
- Intensive exposure to sunlight or UV-rays within the previous month before and after injection visits.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Study for the Safety and Effectiveness of Use of an Injectable Medical Device GANA V® for Facial Aesthetic Treatment
The purpose of this study is to assess the effectiveness and safety of Gana V, a Poly L-lactic acid filler for the aesthetic treatment of nasolabial folds, in comparison with Sculptra.
Read the detailed description
A screening visit will allow to inform and preselect the participants.
On D0, baseline scoring, fringe projection acquisitions and photographs will be done before injection. Eligible participants will receive a first injection of the two products according to the randomization list. Immediately after injection, injector's treatment satisfaction will be collected. Investigator evaluator will collect Adverse Events (AEs) and Injection Site Reactions (ISRs) immediately after injection.
A month and a half after initial injection (M11/2), clinical scoring, fringe projection acquisitions and photographs will be done before touch-up (if applicable). Participant's treatment satisfaction and injector's treatment satisfaction (if applicable) will be collected. A touch-up injection will be made if necessary, according to injector and participant opinion. Investigator evaluator will collect AEs and ISRs before and after touch-up if applicable.
Three (M3), six (M6), nine (M9), twelve (M12), eighteen (M18) and twenty-four (M24) months after initial injection, clinical scoring, fringe projection acquisitions and photographs will be done. Participant's treatment satisfaction will be collected. Investigator evaluator will collect AEs and ISRs
- Conditions
- Wrinkle
- Being tested
- Gana V®, Sculptra®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gana V®Device
Injection in the deep dermis and subcutaneous layer of the nasolabial fold on D0 (initial injection) and 1 month and a half after initial injection if necessary (optional touch-up).
Sculptra®Device
Injection in the deep dermis and subcutaneous layer of the nasolabial fold on D0 (initial injection) and 1 month and a half after initial injection if necessary (optional touch-up).
| Study group | Role | What they receive |
|---|---|---|
| Gana V versus Sculptra | Experimental | Participants will receive both Gana V and Sculptra: one in each nasolabial folds Receives: Device: Gana V®; Device: Sculptra® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in the Nasolabial Folds Severity Score on the Wrinkle Severity Rating Scale (WSRS) 6 Months After Treatment
The Wrinkle Severity Rating Scale is a scale for measurement of the nasolabial folds wrinkles severity.
The scale ranges from Grade 1 (absent-better outcome) to Grade 5 (extreme-worse outcome) Change of grades was calculated as the value at 6 months minus the value at baseline. To observe an improvement of the nasolabial folds wrinkles, a decrease of the mean score was expected.
Measured: Baseline and Month 6
Secondary outcomes (9)
Change From Baseline in the Nasolabial Folds Severity Score on the Wrinkle Severity Rating Scale (WSRS)
The Wrinkle Severity Rating Scale is a scale for measurement of the nasolabial folds wrinkles severity.
The scale ranges from Grade 1 (absent-better outcome) to Grade 5 (extreme-worse outcome) Change of grades was calculated as the value at month X minus the value at baseline. To observe an improvement of the nasolabial folds wrinkles, a decrease of the mean score was expected.
Measured: Baseline, Month 1^1/2, Month 3, Month 6, Month 9, Month 12, Month 18 and Month 24
WSRS Responders Rate
The Wrinkle Severity Rating Scale is a scale for measurement of the nasolabial folds wrinkles severity.
The scale ranges from Grade 1 (absent-better outcome) to Grade 5 (extreme-worse outcome) Responders rate = percentage of participants with an improvement of at least one grade in WSRS compared to baseline score. An improvement represents a decrease in WSRS (from grade 5 to grade 4 for instance)
Measured: Baseline, Month 1^1/2, Month 3, Month 6, Month 9, Month 12, Month 18 and Month 24
Global Aesthetic Improvement Scale (GAIS) Responder Rate
Percentage of participants with an improvement on GAIS. A responder is defined as a subject having "Improved", "Much improved" or "Very much improved" score according to GAIS.
Measured: Month 1^1/2, Month 3, Month 6, Month 9, Month 12, Month 18 and Month 24
Change From Baseline in Nasolabial Folds Average Depth (mm)
The average depth of the nasolabial folds wrinkles was calculated using a fringe projection system. An increase of the mean value means a positive outcome.
Change was calculated as the value at each follow-up visit minus the value at baseline
Measured: Baseline, Month 1^1/2, Month 3, Month 6, Month 9, Month 12, Month 18 and Month 24
Change From Baseline in Nasolabial Folds Volume
The volume of the nasolabial folds wrinkles was calculated using a fringe projection system. A decrease of the volume means a positive outcome.
Measured: Baseline, Month 1^1/2, Month 3, Month 6, Month 9, Month 12, Month 18 and Month 24
Proportion of Satisfied Participants
Percentage of participants with positive answers to an internal questionnaire
Measured: Month 1^1/2, Month 3, Month 6, Month 9, Month 12, Month 18 and Month 24
Injector Satisfaction
Percentage of participants
Measured: After initial injection (Day 0) and touch-up if applicable (Month 1^1/2)
Collection of Injection Site Reactions
Proportion of subjects presenting at least one ISR of any severity
Measured: Day 0, Month 1^1/2, Month 3, Month 6, Month 9, Month 12, Month 18 and Month 24
Collection of Adverse Events
Number of Adverse Events (AEs) Number of Adverse Device Effects (ADEs) Proportion of subjects with at least one AE Proportion of subject with at least one ADE
Measured: Day 0 to Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2022
- Study start7 Mar 2022
- Primary completion7 Nov 2022
- Study completion7 May 2024
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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for WrinkleStudies 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
- Model description
- All participants will receive both fillers
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- GCS Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eurofins Dermscan Pharmascan
- Responsible party
- Sponsor
- Investigators
- Patricia Morel, Doctor, Principal investigator, Eurofins Dermscan Pharmascan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05215054
- Sponsor's protocol ID
- 21E0787
- Other IDs
- 2021-A02451-40
- Acronym
- PLLA
- Status last verified
- Jan 2025
- First submitted
- 3 Jan 2022
- Last updated
- 20 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kim H, Kim HJ, Han WY, Yon DK. Final Report on the Safety and Efficacy of Poly-L-Lactic Acid Filler (Gana V) Injection for the Correction of Nasolabial Fold: A Double-Blind, Non-Inferiority, Randomized, Split-Face Controlled Trial. Aesthetic Plast Surg. 2026 Jan;50(1):9-17. doi: 10.1007/s00266-025-05190-3. Epub 2025 Sep 2.
PubMed 40897963Han WY, Kim HJ, Kwon R, Kang SM, Yon DK. Safety and Efficacy of Poly-L-Lactic Acid Filler (Gana V vs. Sculptra) Injection for Correction of the Nasolabial Fold: A Double-Blind, Non-Inferiority, Randomized, Split-Face Controlled Trial. Aesthetic Plast Surg. 2023 Oct;47(5):1796-1805. doi: 10.1007/s00266-023-03600-y. Epub 2023 Aug 25.
PubMed 37626137
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study for the Safety and Effectiveness of Use of an Injectable Medical Device GANA V® for Facial Aesthetic Treatment
- ClinicalTrials.gov ID
- NCT05215054
- Acronym / sponsor ID
- PLLA / 21E0787
- Conditions
- Wrinkle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- GCS Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Eurofins Dermscan Pharmascan
- Study start
- 7 Mar 2022 (actual)
- Primary completion
- 7 Nov 2022 (actual)
- Study completion
- 7 May 2024 (actual)
- First posted
- 31 Jan 2022 (actual)
- Results
- Posted 20 Jan 2025
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 is to assess the effectiveness and safety of Gana V, a Poly L-lactic acid filler for the aesthetic treatment of nasolabial folds, in comparison with Sculptra.
Detailed description
A screening visit will allow to inform and preselect the participants.
On D0, baseline scoring, fringe projection acquisitions and photographs will be done before injection. Eligible participants will receive a first injection of the two products according to the randomization list. Immediately after injection, injector's treatment satisfaction will be collected. Investigator evaluator will collect Adverse Events (AEs) and Injection Site Reactions (ISRs) immediately after injection.
A month and a half after initial injection (M11/2), clinical scoring, fringe projection acquisitions and photographs will be done before touch-up (if applicable). Participant's treatment satisfaction and injector's treatment satisfaction (if applicable) will be collected. A touch-up injection will be made if necessary, according to injector and participant opinion. Investigator evaluator will collect AEs and ISRs before and after touch-up if applicable.
Three (M3), six (M6), nine (M9), twelve (M12), eighteen (M18) and twenty-four (M24) months after initial injection, clinical scoring, fringe projection acquisitions and photographs will be done. Participant's treatment satisfaction will be collected. Investigator evaluator will collect AEs and ISRs
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will receive both fillers
| Arm | Type | Receives |
|---|---|---|
| Gana V versus Sculptra | Experimental | Device: Gana V®, Device: Sculptra®Participants will receive both Gana V and Sculptra: one in each nasolabial folds |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subject with moderate to severe nasolabial folds as determined by a Wrinkle Severity Rating Scale (WSRS) score of 3 or 4 on both folds at the pre-treatment evaluation.
- Subject wiling to abstain from other facial procedures (i.e., dermal fillers, toxin treatments, laser, microdermal abrasion, chemical peels, non-invasive skin-tightening) during the whole study period.
- Subject, psychologically able to understand the study related information and to give a written informed consent.
- Subject having given freely and expressly his/her informed consent.
- Subject willing to have photographs of the face taken.
Key exclusion criteria (25 listed)
- Pregnant or nursing woman or planning a pregnancy during the study.
- Subject with a scar, moles, pigment disorders or anything on the face which might interfere with the evaluation.
- Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship.
- Subject in a social or sanitary establishment
- Subject participation to another research on human beings or who is in an exclusion period of one.
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 |
|---|---|---|
| Gana V®Injection in the deep dermis and subcutaneous layer of the nasolabial fold on D0 (initial injection) and 1 month and a half after initial injection if necessary (optional touch-up). | Device | Gana V versus Sculptra |
| Sculptra®Injection in the deep dermis and subcutaneous layer of the nasolabial fold on D0 (initial injection) and 1 month and a half after initial injection if necessary (optional touch-up). | Device | Gana V versus Sculptra |
Primary outcome
Change From Baseline in the Nasolabial Folds Severity Score on the Wrinkle Severity Rating Scale (WSRS) 6 Months After Treatment
Time frame: Baseline and Month 6
The Wrinkle Severity Rating Scale is a scale for measurement of the nasolabial folds wrinkles severity. The scale ranges from Grade 1 (absent-better outcome) to Grade 5 (extreme-worse outcome) Change of grades was calculated as the value at 6 months minus the value at baseline. To observe an improvement of the nasolabial folds wrinkles, a decrease of the mean score was expected.
9 secondary outcomes
Change From Baseline in the Nasolabial Folds Severity Score on the Wrinkle Severity Rating Scale (WSRS)
Time frame: Baseline, Month 1^1/2, Month 3, Month 6, Month 9, Month 12, Month 18 and Month 24
WSRS Responders Rate
Time frame: Baseline, Month 1^1/2, Month 3, Month 6, Month 9, Month 12, Month 18 and Month 24
Global Aesthetic Improvement Scale (GAIS) Responder Rate
Time frame: Month 1^1/2, Month 3, Month 6, Month 9, Month 12, Month 18 and Month 24
Change From Baseline in Nasolabial Folds Average Depth (mm)
Time frame: Baseline, Month 1^1/2, Month 3, Month 6, Month 9, Month 12, Month 18 and Month 24
Change From Baseline in Nasolabial Folds Volume
Time frame: Baseline, Month 1^1/2, Month 3, Month 6, Month 9, Month 12, Month 18 and Month 24
Proportion of Satisfied Participants
Time frame: Month 1^1/2, Month 3, Month 6, Month 9, Month 12, Month 18 and Month 24
Injector Satisfaction
Time frame: After initial injection (Day 0) and touch-up if applicable (Month 1^1/2)
Collection of Injection Site Reactions
Time frame: Day 0, Month 1^1/2, Month 3, Month 6, Month 9, Month 12, Month 18 and Month 24
Collection of Adverse Events
Time frame: Day 0 to Month 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40897963Kim H, Kim HJ, Han WY, Yon DK. Final Report on the Safety and Efficacy of Poly-L-Lactic Acid Filler (Gana V) Injection for the Correction of Nasolabial Fold: A Double-Blind, Non-Inferiority, Randomized, Split-Face Controlled Trial. Aesthetic Plast Surg. 2026 Jan;50(1):9-17. doi: 10.1007/s00266-025-05190-3. Epub 2025 Sep 2.
- Derived from this study: PubMed 37626137Han WY, Kim HJ, Kwon R, Kang SM, Yon DK. Safety and Efficacy of Poly-L-Lactic Acid Filler (Gana V vs. Sculptra) Injection for Correction of the Nasolabial Fold: A Double-Blind, Non-Inferiority, Randomized, Split-Face Controlled Trial. Aesthetic Plast Surg. 2023 Oct;47(5):1796-1805. doi: 10.1007/s00266-023-03600-y. Epub 2023 Aug 25.
- 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.
Patricia Morel, Doctor principal investigator
Eurofins Dermscan Pharmascan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gana V® and Sculptra® in people with Wrinkle, run by GCS Co., Ltd at 1 site in France.
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 7 inclusion and 25 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 20 Jan 2025. 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 France. 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?
Yes. Results are posted in the registry (first posted 20 Jan 2025). 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?
Change From Baseline in the Nasolabial Folds Severity Score on the Wrinkle Severity Rating Scale (WSRS) 6 Months After Treatment (time frame: Baseline and Month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05215054, which also lists 2 linked publications.
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 20 Jan 2025.