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

Wrinkle Clinical Trial

— PLLA  

Official title:

Clinical Study for the Safety and Effectiveness of Use of an Injectable Medical Device GANA V® for Facial Aesthetic Treatment

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05215054
• Other study ID #: 21E0787
• Secondary ID: 2021-A02451-40
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 7, 2022
• Est. completion date: May 6, 2024

Study information

• Verified date: July 2023
• Source: GCS Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 55
• Est. completion date: May 6, 2024
• Est. primary completion date: November 7, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Wrinkle

Intervention

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).
• 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).

Locations

Country	Name	City	State
France	Eurofins Dermscan Pharmascan	Villeurbanne

Sponsors (2)

Lead Sponsor	Collaborator
GCS Co., Ltd	Eurofins Dermscan Pharmascan

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in the nasolabial folds severity score on the Wrinkle Severity Rating Scale (WSRS) 6 months after treatment	The WSRS is a validated scale for the evaluation of nasolabial folds severity. Possible scores range from 1 (absent) to 5 (extremely). This score will be assessed by a blinded evaluator in live.	Baseline and Month 6
Secondary	Change from baseline in the nasolabial folds severity score on the Wrinkle Severity Rating Scale (WSRS)	The WSRS is a validated scale for the evaluation of nasolabial folds severity. Possible scores range from 1 (absent) to 5 (extremely). This score will be assessed by a blinded evaluator in live.	Baseline, Month 1^1/2, Month 3, Month 9, Month 12, Month 18 and Month 24
Secondary	WSRS responders rate	The WSRS is a validated scale for the evaluation of nasolabial folds severity. Possible scores range from 1 (absent) to 5 (extremely). A responder is defined as a subject with at least 1-point improvement from baseline on the WSRS. This score will be assessed by a blinded evaluator in live.	Baseline, Month 1^1/2, Month 3, Month 6, Month 9, Month 12, Month 18 and Month 24
Secondary	Global Aesthetic Improvement Scale (GAIS) responder rate	The GAIS is a validated scale for the evaluation of aesthetic improvement. Possible scores range from 1 (very much improved) to 5 (worse). A responder is defined as a subject having "Improved", "Much improved" or "Very much improved" score according to GAIS. This score will be assessed by a blinded evaluator in live and by the participants.	Month 1^1/2, Month 3, Month 6, Month 9, Month 12, Month 18 and Month 24
Secondary	Change from baseline in nasolabial folds depth	This will be assessed using 3D acquisitions of the face	Baseline, Month 1^1/2, Month 3, Month 6, Month 9, Month 12, Month 18 and Month 24
Secondary	Change from baseline in nasolabial folds volume	This will be assessed using 3D acquisitions of the face	Baseline, Month 1^1/2, Month 3, Month 6, Month 9, Month 12, Month 18 and Month 24
Secondary	Proportion of satisfied participants	With a questionnaire	Month 1^1/2, Month 3, Month 6, Month 9, Month 12, Month 18 and Month 24
Secondary	Injector satisfaction	The investigator who will inject the products will complete a questionnaire for each participant.	After initial injection (Day 0) and touch-up if applicable (Month 1^1/2)
Secondary	Collection of injection site reactions	Collection by the participants until one month after injection and by the investigator at each visit	Day 0, Month 1^1/2, Month 3, Month 6, Month 9, Month 12, Month 18 and Month 24
Secondary	Collection of adverse events	Collection by the participants during the whole study period and by the investigator at each visit	Day 0 to Month 24