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 (PLLA)

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.

Study Overview

• Status: Completed
• Conditions: Wrinkle
• Intervention / Treatment: Device: Gana V®; Device: 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 Type: Interventional
• Enrollment (Actual): 59
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Villeurbanne, France, 69100
    • Eurofins DERMSCAN PHARMASCAN

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Gana V versus Sculptra; Participants will receive both Gana V and Sculptra: one in each nasolabial folds

Device: 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: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and Month 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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)	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.	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	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.	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	Month 1^1/2, Month 3, Month 6, Month 9, Month 12, Month 18 and Month 24
Injector Satisfaction	Percentage of participants	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	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	Day 0 to Month 24

Collaborators and Investigators

• Sponsor: GCS Co., Ltd
• Collaborators: Eurofins Dermscan Pharmascan
• Investigators: Principal Investigator: Patricia Morel, Doctor, Eurofins DERMSCAN PHARMASCAN

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2022
• Primary Completion (Actual): November 7, 2022
• Study Completion (Actual): May 7, 2024

Study Registration Dates

• First Submitted: January 3, 2022
• First Submitted That Met QC Criteria: January 17, 2022
• First Posted (Actual): January 31, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 17, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 21E0787; 2021-A02451-40 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No