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

NCT05215054 | Completed Results

• 2 other identifiers: 21E07872021-A02451-40
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Wrinkle

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Change From Baseline in the Nasolabial Folds Severity Score on the Wrinkle Severity Rating Scale (WSRS)

  Baseline, Month 1^1/2, Month 3, Month 6, Month 9, Month 12, Month 18 and Month 24

• WSRS Responders Rate

  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

  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)

  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

  Baseline, Month 1^1/2, Month 3, Month 6, Month 9, Month 12, Month 18 and Month 24

Study Arms (1)

Gana V versus Sculptra

EXPERIMENTAL

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

Device: Gana V®; Device: Sculptra®

Interventions

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).

Gana V versus Sculptra

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).

Gana V versus Sculptra

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• GCS Co., Ltd: lead
• Eurofins Dermscan Pharmascan: collaborator

Study Sites (1)

Eurofins Dermscan Pharmascan

Villeurbanne, 69100, France

Location

Related Publications (2)

• 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. 2025 Sep 2. doi: 10.1007/s00266-025-05190-3. Online ahead of print.

  PMID: 40897963 DERIVED

• Han 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.

  PMID: 37626137 DERIVED

Limitations and Caveats

* Primary assessment subjective * Low quantity of product injected compared to other study found in the litterature * Comparator chosen is not the same concentration as Gana V

Results Point of Contact

• Title: Florence REBER
• Organization: Eurofins Dermscan Pharmascan

Florence.Reber@cpt.eurofinseu.com

0472823656

Study Officials

• Patricia Morel, Doctor

  Eurofins Dermscan Pharmascan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Participants and investigators assessors will not know which filler was used on each side of the face (hemi-face design)
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All participants will receive both fillers

Study Record Dates

• First Submitted: January 3, 2022
• First Posted: January 31, 2022
• Study Start: March 7, 2022
• Primary Completion: November 7, 2022
• Study Completion: May 7, 2024
• Last Updated: January 20, 2025
• Results First Posted: January 20, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)