Lips EnhancementNCT04971876
Evaluation of the Safety and Performance of an Injectable Hyaluronic Acid Filler
A study testing HLR-1, HLR-2 and HLR-3 in people with Lips Enhancement and Nasolabial Fold Correction, run by Hallura Ltd. at 3 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lips Enhancement, Nasolabial Fold Correction, Midface Volume Deficit
- What is being tested?
- HLR-1, HLR-2 and HLR-3
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 27 Oct 2020to 6 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
- 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;
- Group 2: Moderate to severe nasolabial folds (NLFs) with WSRS scale score 3 or 4 for each side of the face;
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Germany2 sites
Rosenpark Research GmbH
Darmstadt
Private Practice Dr.Hilton & Partner GbR
Düsseldorf, 40212
About this study
Official title: 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.
- Being tested
- HLR-1, HLR-2, HLR-3
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HLR-1Device
Initial injection of HLR-1 and optional TU after 4 weeks. Maximum injection volume for each treatment session is 3mL.
HLR-2Device
Initial injection of HLR-2 and optional TU after 4 weeks. Maximum injection volume for each treatment session is 3mL per NLF.
HLR-3Device
Initial injection of HLR-3 and optional TU after 4 weeks. Maximum injection volume for each treatment session is 4mL per cheek.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - Lips Enhancement | Experimental | Participants treated with HLR-1 for lip enhancement, with optional Touch-Up (TU) 4 weeks afterwards Receives: Device: HLR-1 |
| Group 2 - Nasolabial Fold Correction | Experimental | Participants treated with HLR-2 for nasolabial folds (NLFs) correction, with optional Touch-Up (TU) 4 weeks afterwards Receives: Device: HLR-2 |
| Group 3 - Treatment of Midface Volume Deficit | Experimental | Participants treated with HLR-3 for treatment of midface volume deficit, with optional Touch-Up (TU) 4 weeks afterwards Receives: Device: HLR-3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Month 3 for Group 1, Month 6 for Groups 2 and 3
Secondary outcomes (3)
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
Measured: 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
Measured: Month 12
Performance Based on ILE Scores Compared to Baseline
ILE Scoring on the relevant photo-numerical scale
Measured: Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2021
- Study start27 Oct 2020
- Primary completion11 Aug 2022
- Study completion6 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lips EnhancementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hallura Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04971876
- Sponsor's protocol ID
- 19E2031
- Status last verified
- Nov 2022
- First submitted
- 29 Jun 2021
- Last updated
- 3 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Interventional, Non-Randomized, Open Label Study for the Evaluation of the Safety and Performance of an Injectable Hyaluronic Acid Filler
- ClinicalTrials.gov ID
- NCT04971876
- Acronym / sponsor ID
- 19E2031
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Hallura Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 Oct 2020 (actual)
- Primary completion
- 11 Aug 2022 (actual)
- Study completion
- 6 Sep 2022 (actual)
- First posted
- 22 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 - Lips Enhancement | Experimental | Device: HLR-1Participants treated with HLR-1 for lip enhancement, with optional Touch-Up (TU) 4 weeks afterwards |
| Group 2 - Nasolabial Fold Correction | Experimental | Device: HLR-2Participants treated with HLR-2 for nasolabial folds (NLFs) correction, with optional Touch-Up (TU) 4 weeks afterwards |
| Group 3 - Treatment of Midface Volume Deficit | Experimental | Device: HLR-3Participants treated with HLR-3 for treatment of midface volume deficit, with optional Touch-Up (TU) 4 weeks afterwards |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HLR-1Initial injection of HLR-1 and optional TU after 4 weeks. Maximum injection volume for each treatment session is 3mL. | Device | Group 1 - Lips Enhancement |
| HLR-2Initial injection of HLR-2 and optional TU after 4 weeks. Maximum injection volume for each treatment session is 3mL per NLF. | Device | Group 2 - Nasolabial Fold Correction |
| HLR-3Initial injection of HLR-3 and optional TU after 4 weeks. Maximum injection volume for each treatment session is 4mL per cheek. | Device | Group 3 - Treatment of Midface Volume Deficit |
Primary outcome
Responder Rate
Time frame: Month 3 for Group 1, Month 6 for Groups 2 and 3
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).
3 secondary outcomes
Aesthetic Improvement Based on Global Aesthetic Improvement Scale (GAIS) Subject and Investigator
Time frame: Month 12
Subject's Satisfaction Based on FACE-Q
Time frame: Month 12
Performance Based on ILE Scores Compared to Baseline
Time frame: Month 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HLR-1, HLR-2 and HLR-3 in people with Lips Enhancement and Nasolabial Fold Correction, run by Hallura Ltd. at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Responder Rate (time frame: Month 3 for Group 1, Month 6 for Groups 2 and 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2022.