Status:
COMPLETED
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
Lead Sponsor:
GCS Co., Ltd
Collaborating Sponsors:
Eurofins Dermscan Pharmascan
Conditions:
Wrinkle
Eligibility:
All Genders
30-70 years
Phase:
NA
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.
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 wil...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 7 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 7 2024
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT05215054
Start Date
March 7 2022
End Date
May 7 2024
Last Update
January 20 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Eurofins Dermscan Pharmascan
Villeurbanne, France, 69100