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

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.

Study Overview

• Status: Completed
• Conditions: Midface Volume Deficit; Nasolabial Fold Correction; Lips Enhancement
• Intervention / Treatment: Device: HLR-1; Device: HLR-2; Device: HLR-3

• Study Type: Interventional
• Enrollment (Actual): 132
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Darmstadt, Germany
    • Rosenpark Research GmbH
  • Düsseldorf, Germany, 40212
    • Private Practice Dr.Hilton & Partner GbR
• Poland
  • Warszawa, Poland
    • Centrum Medyczne Evimed

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.
• Inflammatory and/or infectious cutaneous disorders in or near the treatment area (herpes, acne, mycosis, papilloma, rosacea, blotches or other pathology on the treatment area, at the investigator appreciation). Subject with recurrent herpes is not eligible even if asymptomatic at time of inclusion.
• 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.
• Have undergone semi-permanent dermal filler treatment (e.g., calcium hydroxylapatite, poly-L-lactic acid, etc.) in the face within 24 months before enrolment.
• Have received at any time a treatment with tensor threads or gold strands on the face.
• Intensive exposure to sunlight or UV-rays within the previous month and/or foreseen during the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1 - Lips Enhancement; Participants treated with HLR-1 for lip enhancement, with optional Touch-Up (TU) 4 weeks afterwards	Device: HLR-1; Initial injection of HLR-1 and optional TU after 4 weeks. Maximum injection volume for each treatment session is 3mL.
Experimental: Group 2 - Nasolabial Fold Correction; Participants treated with HLR-2 for nasolabial folds (NLFs) correction, with optional Touch-Up (TU) 4 weeks afterwards	Device: HLR-2; Initial injection of HLR-2 and optional TU after 4 weeks. Maximum injection volume for each treatment session is 3mL per NLF.
Experimental: Group 3 - Treatment of Midface Volume Deficit; Participants treated with HLR-3 for treatment of midface volume deficit, with optional Touch-Up (TU) 4 weeks afterwards	Device: HLR-3; Initial injection of HLR-3 and optional TU after 4 weeks. Maximum injection volume for each treatment session is 4mL per cheek.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Responder Rate	Improvement measured by the responders rate, with a responder defined as a score improved by at least one grade from baseline, i.e. pre-treatment, as determined by the Investigator Live-Evaluator (ILE) using the relevant photo-numerical scale: ROSSI to evaluate the lip volume deficit for subjects in group 1 (scores between 1 and 5 including half scores with higher scores representing fuller lip), Wrinkle Severity Rating Scale (WSRS) for subjects in group 2 (scores between 1 and 5 where higher score represents more pronounced NLF), and Mid-Face Volume Deficit Scale (MFVDS) for subjects in group 3 (scores between 0 and 5 with lower scores representing less volume deficit).	Month 3 for Group 1, Month 6 for Groups 2 and 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Aesthetic Improvement Based on Global Aesthetic Improvement Scale (GAIS) Subject and Investigator	GAIS is evaluated at Week 2 visit, Month 1, Month 3, Month 6, Month 9, Month 12	Month 12
Subject's Satisfaction Based on FACE-Q	FACE-Q Satisfaction with Lips for Group 1, FACE-Q Appraisal of Lines: Nasolabial Folds, FACE-Q Satisfaction with Cheeks evaluated at Week 2 visit, Month 1, Month 3, Month 6, Month 9, Month 12	Month 12
Performance Based on ILE Scores Compared to Baseline	ILE Scoring on the relevant photo-numerical scale	Month 12

Collaborators and Investigators

• Sponsor: Hallura Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2020
• Primary Completion (Actual): August 11, 2022
• Study Completion (Actual): September 6, 2022

Study Registration Dates

• First Submitted: June 29, 2021
• First Submitted That Met QC Criteria: July 20, 2021
• First Posted (Actual): July 22, 2021

Study Record Updates

• Last Update Posted (Actual): November 3, 2022
• Last Update Submitted That Met QC Criteria: November 2, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 19E2031

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No