Clinical Trials Logo
  1. Home
  2. Wrinkle
  3. NCT05215054

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  

Wrinkle Clinical Trial

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

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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05215054
Study type Interventional
Source GCS Co., Ltd
Contact
Status Active, not recruiting
Phase N/A
Start date March 7, 2022
Completion date May 6, 2024
View Details
See also
  Status Clinical Trial Phase
Completed NCT05098912 - Comparing Polydioxanone Thread Embedding Acupuncture and Manual Acupuncture for Nasolabial Fold Reduction N/A
Completed NCT05271136 - A Clinical Study to Evaluate the Efficacy of an Anti-Aging Serum N/A
Completed NCT05096247 - Post Market Study To Collect Efficacy Data For The Treatment Of Wrinkles With A Radiofrequency Device N/A
Completed NCT05097157 - Study To Assess A Radiofrequency Microneedling Device For Dermatologic Conditions N/A
Completed NCT04128046 - The Effect of Platelet-rich Fibrin Matrix on Skin Rejuvenation N/A
Active, not recruiting NCT04727099 - Clinical Evaluation to Demonstrate the Safety and Performance of the Candela PicoWay System™ N/A
Active, not recruiting NCT06140628 - A 28-day Clinical Study on Facial Skin Rejuvenation N/A
Not yet recruiting NCT05524779 - BTL-785F Device for Non-invasive Reduction of Wrinkles and Overall Facial Improvement N/A
Completed NCT05514782 - A Clinical Study to Evaluate the Long-Term Efficacy and Tolerability of a Daily Anti-Aging Daily Serum N/A
Completed NCT06123572 - A Clinical Study to Assess the Safety and Effectiveness of Anti-Ageing and Skin Brightening Gel N/A
Completed NCT04911374 - An Open-Label Clinical Study to Evaluate the Efficacy of a Face Cream and Eye Cream N/A
Recruiting NCT04989361 - Soluble Hyaluronic Acid Microneedle VS. Non-ablative Fractional Laser on Infraorbital Wrinkles. N/A
Recruiting NCT04540900 - A Phase I Study of KB301, a Replication-Incompetent, Non-Integrating Vector Expressing Human Type III Collagen (COL3) for the Treatment of Superficial Skin Depressions Phase 1
Recruiting NCT06074276 - The Effects of Almond on Facial Skin Collagen and Wrinkles N/A
Recruiting NCT06202274 - Clinical Study to Evaluate the Safety and Efficacy of Candela Technology N/A
Completed NCT06366503 - Evaluating Procedure Pairing of a Post-Procedure Cream Versus a Comparator in Patients Treated With Fractional Ablative CO2 Laser for Facial Rejuvenation N/A
Active, not recruiting NCT06219278 - A Retrospective Review Evaluating the Matrix Pro Applicator for Treatment of Wrinkles N/A
Active, not recruiting NCT06192550 - Functional Usability and Feasibility Testing of the Profound Matrix™ System N/A
Completed NCT04650620 - Study to Evaluate the Performance and Safety of the Medical Device Plenhyage® N/A
Completed NCT03729700 - The Effect of Almonds on Facial Aesthetics and Modulation of the Microbiome and Lipidome N/A