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Evaluation of the Safety and Performance of an Injectable Hyaluronic Acid Filler | Clinical Trials | Clareo Health

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Evaluation of the Safety and Performance of an Injectable Hyaluronic Acid Filler

Prospective, Interventional, Non-Randomized, Open Label Study for the Evaluation of the Safety and Performance of an Injectable Hyaluronic Acid Filler

NCT04971876•Hallura Ltd.

View on ClinicalTrials.gov

Summary

Evaluation of the safety and performance of the investigational device in its three concentrations for cheek and lips augmentation and correction of the nasolabial folds, assuming that the performance of the product will be demonstrated based on the responder rates observed compared to baseline.

Eligibility

Age

21 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Healthy Subject;
•Male or female, over the age of 21;
•Seeking an aesthetic procedure on the face and can be classified into one of the following groups:
•1. Group1: Lip volume deficit with ROSSI score between 1.5 and 3 on at least the upper lip, or on both the upper and the lower lips with up to 1 point difference in ROSSI score between upper and lower lips;
•2. Group 2: Moderate to severe nasolabial folds (NLFs) with WSRS scale score 3 or 4 for each side of the face;
•3. Group 3: Mild to significant volume deficit at the cheeks level with MFVDS score 2 to 4 at each side, with up to 1 point difference in MFVDS scale score between the two sides.
•Investigator Live-Evaluator (ILE) and Injector must independently agree that the criteria is met, however concordance of the scores is not required.
•Willing to abstain from any aesthetic treatment on the face other than the treatments planned in the protocol during the study period.

Exclusion Criteria

•Anything on the treatment site which might interfere with the evaluation (tattoo, scar, moles, too many hairs).
•Subject with mid-face volume deficit due to congenital defect, trauma, abnormalities in adipose tissue related to immune-mediated diseases such as generalized lipodystrophy (e.g., juvenile dermatomyositis), partial lipodystrophy (e.g., Barraquer-Simons syndrome), inherited disease, or HIV-related disease, and/or severe malocclusion or dentofacial or maxillofacial deformities.
•Known history of multiple allergies, allergic/anaphylactic reactions including allergy to lidocaine or anaesthetics of the amide type, to hyaluronic acid products, or to Grampositive bacterial proteins.
•History or current autoimmune disease and/or immune deficiency.
•History of streptococcal disease (such as acute rheumatic fever or recurrent sore throats), precancerous lesions/skin malignancies, hyper- or hypo-pigmentation in face.
•Subject prone to develop inflammatory skin conditions or having tendency to bleeding disorders.
•Received (or is planning to receive) anti-coagulation, anti-platelet, or thrombolytic medications (e.g., warfarin), anti-inflammatory drugs \[oral/injectable corticosteroids or Non-Steroidal Anti-Inflammatory Drugs (NSAIDs, e.g., aspirin, ibuprofen)\], or other substances known to increase coagulation time from 10 days pre- to 3 days post injection \[Study device injections may be delayed as necessary to accommodate this 10-day washout period.\]
•Have received at any time permanent facial implants (e.g. polyacrylamide, silicone) anywhere in the face or neck.
•Botulinum toxin injections, mesotherapy, or resurfacing (laser, photomodulation, intense pulsed light, radio frequency, dermabrasion, chemical peel, or other ablative or non-ablative procedures) within 6 months prior to entry in the study.
•Have received injection with a temporary bioresorbable facial dermal filler (e.g., hyaluronic acid, collagen, autologous fat, etc.) within the past 12 months prior to study start.
+3 more criteria

Locations (3)

Rosenpark Research GmbH

Darmstadt, Germany

Private Practice Dr.Hilton & Partner GbR

Düsseldorf, Germany

Centrum Medyczne Evimed

Warsaw, Poland

Key Dates

Start Date

October 27, 2020

Primary Completion Date

August 11, 2022

Completion Date

September 6, 2022

Last Updated

November 3, 2022

Enrollment

132

ACTUAL participants

Conditions

Lips EnhancementNasolabial Fold CorrectionMidface Volume Deficit

Interventions

HLR-1

DEVICE

HLR-2

DEVICE

HLR-3

DEVICE

Evaluation of Facial HA Dermal Fillers in Real-Life Conditions

NCT07255261

Lips EnhancementPerioral Wrinkles+3 more

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COMPLETEDPHASE3

Saypha® VOLUME Lidocaine for Midface Augmentation

NCT05386030

Moderate to Severe Midface Volume Deficit

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COMPLETED

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 3, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Evaluation of the Safety and Performance of an Injectable Hyaluronic Acid Filler

Inclusion Criteria

Exclusion Criteria

Evaluation of Facial HA Dermal Fillers in Real-Life Conditions

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