Mid Face Volume DeficitTIMINCT06128109
THIODERM STRONG Compared to Juvéderm® VOLUMA® Lidocaine for the Treatment of Midface Volume Deficit
A study testing Thioderm Strong and Juvéderm VOLUMA Lidocaine in people with Mid Face Volume Deficit, run by Croma-Pharma GmbH at 1 site in Austria.
Trial summary
This mono-center clinical investigation is intended to evaluate the safety and effectiveness of THIODERM STRONG (test device) in the correction of moderate to severe midface volume deficit compared to Juvéderm® VOLUMA® Lidocaine (comparator device). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Mid Face Volume Deficit
- What is being tested?
- Thioderm Strong and Juvéderm VOLUMA Lidocaine
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteAustria
- Study dates
- 24 Jan 2023to 9 Jan 2024
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥ 18 years at the time of screening (upper limit 75 years, inclusive).
- Subjects with bilateral, approximately symmetric moderate to severe midface volume deficit (severity scores of 2 or 3 on the 5-point Midface Volume Deficit Severity Scale), shown by the same rating on both sides, assessed by the Blinded Evaluating Investigator.
- Healthy skin in the midface area and free of diseases that could interfere in cutaneous aging evaluation.
- Subject has a stable medical condition with no uncontrolled systemic disease.
- Females of childbearing potential must have a negative urine pregnancy test and must agree to use a highly effective method of birth control throughout the entire study1.
- Male subjects with female partners of child-bearing potential must agree to use contraception throughout the entire study (surgical sterilization or a physical barrier such as a condom).
- Willingness to abstain from any aesthetic or surgical procedures in the treatment area for the duration of study, including botulinum toxin injection (except glabella or forehead botulinum toxin treatment).
- Subjects who understand the purpose and conduct of the study and having given written informed consent and are willing and able to attend the study visits as judged by the Investigator.
Who cannot join
- Females, who are pregnant and/or, lactating or planning to become pregnant during the clinical investigation.
- History of allergies or hypersensitivity to hyaluronic acid and/or to gram positive bacterial proteins, lidocaine, or any amide-based anaesthetic
- History of severe allergies manifested by a history of anaphylaxis or history or presence of multiple severe allergies.
- Tendency to keloid formation and/or hypertrophic scars.
- Presence of infectious, inflammatory, or proliferative cancerous or pre-cancerous lesions in the area to be treated.
- Recurrent (three times a year over the last year) herpes simplex in the treatment areas
Show all 29Show fewer
- Known human immune deficiency virus-positive individuals.
- History or presence of any autoimmune or connective tissue disease
- Uncontrolled (or unstable) Diabetes mellitus or uncontrolled systemic diseases as per Investigator discretion.
- Previous facial plastic surgery, tissue augmentation with silicone, fat or another non-absorbable substance (permanent fillers) and semi-permanent / long-lasting fillers (e.g., poly-L-lactic acid (PLLA), Polymethylmethacrylate (PMMA) filler) in the area of device application and during the entire investigation
- Implantation of dermal fillers in the treatment area within the preceding 24 months prior to Visit 0 (Screening) and during the entire investigation
- Subject has received any of the following aesthetic treatments in the midface area: e.g., laser therapy, absorbable and non-absorbable sutures (threads), dermabrasion, mesotherapy, micro-needling and/or botulinum toxin (including treatment of crow´s feet in the outer eye region) within the last 12 months prior to Visit 1, chemical peeling within the last three months prior to Visit 1 or is planning to undergo such procedures during entire investigation
- Facial lipolysis, including submental fat treatments, within the previous 12 months prior to Visit 0 (Screening) and during the entire investigation
- Bariatric surgery within 12 months prior to Visit 0 (Screening) and during the entire investigation.
- History of bleeding disorder and/or use of anticoagulant, antiplatelet or thrombolytic medication, including nutrition supplements that potentially prolong coagulation, from 10 days pre- to 3 days post-injection (initial treatment and touch-up treatment).
- Systemic glucocorticoids, including immunosuppressant or immunomodulators, within 8 weeks prior to undergoing investigational device injections.
- Patients suffering from untreated epilepsy.
- Patients with acute rheumatic fever with heart complications.
- Patients with symptoms of cardiac conduction disorders.
- Planned dental/oral surgery or modification (bridgework, implants) within four weeks prior to each injection and to a minimum of four weeks post injection (initial treatment, touch-up treatment).
- Beard longer than three-day beard, or excessive facial hair that could interfere in evaluation of treatment as judged by the Investigator.
- Subjects with active SARS-CoV-2019 infection and Subjects with symptoms consistent with COVID-19 infection including any other respiratory symptoms/illnesses within the past 14 days unless tested negative prior to Visit 0 (Screening).
- Any medical condition prohibiting the inclusion in the clinical investigation according to the judgment of the Investigator.
- Previous enrolment in this clinical investigation.
- Current participation in another clinical investigation, or treatment with any investigational drug/medical device within 30 days prior to clinical investigation Visit 0 (Screening), or 5 half-lives of the investigational drug, whichever is longer.
- Midface volume deficit due to a congenital defect, trauma, or abnormalities in facial adipose tissue distribution such as those associated with HIV related lipodystrophy.
- Subjects who experienced fat loss for a minimum of 10% of body weight over the last 12 months (e.g., post bariatric patients), or Subjects who have the intention to change eating habits that result in a weight gain or loss >10% during the entire investigation.
- Close affiliation with the Investigator (e.g., a close relative, financially dependent on the study site) or Subject who is an employee of the Sponsor's company or group companies of the Sponsor.
- Any individual whose willingness to volunteer in this clinical investigation could be unduly influenced by the expectation, whether justified or not, of benefits associated with participation or of retaliatory response from senior members of a hierarchy in case of refusal to participate (e.g., persons with a legal custodian appointed due to mental disability, prisoners, soldiers and other members of the armed forces, civil servants).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Exploratory, Prospective, Randomized, Subject and Evaluator-blinded, Split-face, Single-centre Trial Investigating the Effectiveness and Safety of THIODERM STRONG Compared to Juvéderm® VOLUMA® Lidocaine for the Treatment of Midface Volume Deficit (TIMI)
This mono-center clinical investigation is intended to evaluate the safety and effectiveness of THIODERM STRONG (test device) in the correction of moderate to severe midface volume deficit compared to Juvéderm® VOLUMA® Lidocaine (comparator device).
Read the detailed description
The Investigation is an exploratory, prospective, randomized, subject and evaluator-blinded, split- face, single-centre study investigating the effectiveness and safety of THIODERM STRONG compared to Juvéderm® VOLUMA® Lidocaine for the treatment of moderate to severe midface volume deficit. 20 eligible Subjects will be included in this investigation, after the informed consent form (ICF) has been signed and relevant pre-treatment procedures, including medical history and pregnancy testing, have been performed. Subjects will receive injection in the midface region using THIODERM STRONG and Juvéderm® VOLUMA® Lidocaine until an optimal aesthetic result is achieved. The Blinded Evaluating Investigator will determine severity of the Subject's midface volume deficit using the 5-point MVDSS throughout the investigation (Baseline to Week 24). Baseline is defined as the assessment prior to administration of the IMDs. The same Investigator will assess the Subject using the 5-point MVDSS at all visits. An optional touch-up treatment can be performed at Week 4 upon discretion of the Unblinded Treating Investigator. The effectiveness and safety of the treatment will be evaluated after Day 1, 3 and 7 as well as at 4, 8, 16 and 24 weeks using objective and subjective outcome parameters. An interim analysis will be performed when all Subjects have completed the visit at Week 8.
- Conditions
- Mid Face Volume Deficit
- Being tested
- Thioderm Strong, Juvéderm VOLUMA Lidocaine
- Keywords
- Midface, Volume Deficit, Hyaluronic Acid, Dermal Filler
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thioderm StrongDevice
Test Device
Juvéderm VOLUMA LidocaineDevice
Comparator Device
| Study group | Role | What they receive |
|---|---|---|
| Group THIODERM LEFT | Other | Split Face Design: Test Device left midface and Comparator Device right midface Receives: Device: Thioderm Strong; Device: Juvéderm VOLUMA Lidocaine |
| Group JUVÈDERM LEFT | Other | Split Face Design: Test Device right midface and Comparator Device left midface Receives: Device: Thioderm Strong; Device: Juvéderm VOLUMA Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Magnitude
To assess the effectiveness of THIODERM STRONG in reducing the severity of the midface volume deficit in comparison with Juvéderm® VOLUMA® Lidocaine based on Blinded Evaluating Investigator assessment at Week 24 as measured via the 5-point Midface Volume Deficit Severity Scale (MVDSS).
Measured: 24 Weeks
Secondary outcomes (11)
Total Volume Injected
To assess required total volume for optimum aesthetic result for THIODERM STRONG compared to Juvéderm® VOLUMA® Lidocaine.
Measured: 24 Weeks
Response Rate
To assess the proportion of responders after treatment with THIODERM STRONG in comparison with Juvéderm® VOLUMA® Lidocaine per treated side.
Measured: Day7; Week 4, 8, 16, and 24
Response Magnitude
To assess the change on the 5-point MVDSS from baseline after treatment with THIODERM STRONG in comparison with Juvéderm® VOLUMA® Lidocaine.
Measured: Day 7; Week 4, 8, and 16
Response Magnitude Photographic Review
Change of 5-point MVDSS from baseline to Day 7 and Week 4, 8, 16 and 24 based on the independent blinded evaluating panel's assessment per treated side.
Measured: Day7; Week 4, 8, 16, and 24
Aesthetic Improvement via GAIS - Investigator
Aesthetic improvement based on the Blinded Evaluating Investigator's assessment per treated side at Week 4, 8, 16 and 24 using the GAIS.
Measured: Day7; Week 4, 8, 16, and 24
Aesthetic Improvement via GAIS - Subject
Aesthetic improvement based on the Subject's assessment per treated side at Week 4, 8, 16 and 24 using the GAIS
Measured: Day7; Week 4, 8, 16, and 24
Volume Change via 3D Imaging
Volume change of the midface region at Day 7 and Week 4, 8, 16 and 24, based on 3D surface imaging in comparison to the baseline 3D surface image per treated side.
Measured: Day7; Week 4, 8, 16, and 24
Subject Satisfaction - Face-Q(TM) Outcome Scale
The extent of Subject´s satisfaction with treatment of the midface at Day 1, 3, 7 and Week 4, 8, 16 and 24 as assessed by the FACE-QTM Satisfaction with Outcome Scale per treated side.
Measured: Day 1, 3, and 7; Week 4, 8, 16, and 24
Subject Appearance Appraisal - Face-Q(TM) Satisfaction with Cheeks
The extent of Subject´s appearance appraisal at Day 1, 3, 7 and Week 4, 8, 16 and 24 as assessed by the FACE-QTM Satisfaction with Cheeks Scale per treated side and compared to the score at screening.
Measured: Day 1, 3, and 7; Week 4, 8, 16, and 24
Change of Nasolabial Fold Severity
Change of nasolabial fold severity measured by NLF-SRS from baseline to Day 7 and Week 4, 8, 16 and 24 based on the Blinded Evaluating Investigator's assessment per treated side.
Measured: Day7; Week 4, 8, 16, and 24
Pain Assessment
Subject´s pain assessment after each treatment on an 11-point scale, where 0 is no pain and 10 is the worst pain imaginable per treated side.
Measured: Day 0; Week 4 (in case of touch-up treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start24 Jan 2023
- Primary completion28 Aug 2023
- Study completion9 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mid Face Volume DeficitStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Split-Face Design with random assignment of test device and comparator device to be injected either into right or into left Mid Face Area
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Croma-Pharma GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Proinnovera GmbH
- Responsible party
- Sponsor
- Investigators
- Alice Krames-Juerss, Study director, CROMA Pharma GmbH (Sponsor)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06128109
- Sponsor's protocol ID
- CPH-50501
- Acronym
- TIMI
- Status last verified
- Dec 2024
- First submitted
- 3 Nov 2023
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory, Prospective, Randomized, Subject and Evaluator-blinded, Split-face, Single-centre Trial Investigating the Effectiveness and Safety of THIODERM STRONG Compared to Juvéderm® VOLUMA® Lidocaine for the Treatment of Midface Volume Deficit (TIMI)
- ClinicalTrials.gov ID
- NCT06128109
- Acronym / sponsor ID
- TIMI / CPH-50501
- Conditions
- Mid Face Volume Deficit
- Keywords
- Midface, Volume Deficit, Hyaluronic Acid, Dermal Filler
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Croma-Pharma GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Proinnovera GmbH
- Study start
- 24 Jan 2023 (actual)
- Primary completion
- 28 Aug 2023 (actual)
- Study completion
- 9 Jan 2024 (actual)
- First posted
- 13 Nov 2023 (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.
This mono-center clinical investigation is intended to evaluate the safety and effectiveness of THIODERM STRONG (test device) in the correction of moderate to severe midface volume deficit compared to Juvéderm® VOLUMA® Lidocaine (comparator device).
Detailed description
The Investigation is an exploratory, prospective, randomized, subject and evaluator-blinded, split- face, single-centre study investigating the effectiveness and safety of THIODERM STRONG compared to Juvéderm® VOLUMA® Lidocaine for the treatment of moderate to severe midface volume deficit. 20 eligible Subjects will be included in this investigation, after the informed consent form (ICF) has been signed and relevant pre-treatment procedures, including medical history and pregnancy testing, have been performed. Subjects will receive injection in the midface region using THIODERM STRONG and Juvéderm® VOLUMA® Lidocaine until an optimal aesthetic result is achieved. The Blinded Evaluating Investigator will determine severity of the Subject's midface volume deficit using the 5-point MVDSS throughout the investigation (Baseline to Week 24). Baseline is defined as the assessment prior to administration of the IMDs. The same Investigator will assess the Subject using the 5-point MVDSS at all visits. An optional touch-up treatment can be performed at Week 4 upon discretion of the Unblinded Treating Investigator. The effectiveness and safety of the treatment will be evaluated after Day 1, 3 and 7 as well as at 4, 8, 16 and 24 weeks using objective and subjective outcome parameters. An interim analysis will be performed when all Subjects have completed the visit at Week 8.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Split-Face Design with random assignment of test device and comparator device to be injected either into right or into left Mid Face Area
| Arm | Type | Receives |
|---|---|---|
| Group THIODERM LEFT | Other | Device: Thioderm Strong, Device: Juvéderm VOLUMA LidocaineSplit Face Design: Test Device left midface and Comparator Device right midface |
| Group JUVÈDERM LEFT | Other | Device: Thioderm Strong, Device: Juvéderm VOLUMA LidocaineSplit Face Design: Test Device right midface and Comparator Device left midface |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Aged ≥ 18 years at the time of screening (upper limit 75 years, inclusive).
- Subjects with bilateral, approximately symmetric moderate to severe midface volume deficit (severity scores of 2 or 3 on the 5-point Midface Volume Deficit Severity Scale), shown by the same rating on both sides, assessed by the Blinded Evaluating Investigator.
- Healthy skin in the midface area and free of diseases that could interfere in cutaneous aging evaluation.
- Subject has a stable medical condition with no uncontrolled systemic disease.
- Females of childbearing potential must have a negative urine pregnancy test and must agree to use a highly effective method of birth control throughout the entire study1.
Key exclusion criteria (29 listed)
- Females, who are pregnant and/or, lactating or planning to become pregnant during the clinical investigation.
- History of allergies or hypersensitivity to hyaluronic acid and/or to gram positive bacterial proteins, lidocaine, or any amide-based anaesthetic
- History of severe allergies manifested by a history of anaphylaxis or history or presence of multiple severe allergies.
- Tendency to keloid formation and/or hypertrophic scars.
- Presence of infectious, inflammatory, or proliferative cancerous or pre-cancerous lesions in the area to be treated.
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 |
|---|---|---|
| Thioderm StrongTest Device | Device | Group JUVÈDERM LEFT, Group THIODERM LEFT |
| Juvéderm VOLUMA LidocaineComparator Device | Device | Group JUVÈDERM LEFT, Group THIODERM LEFT |
Primary outcome
Response Magnitude
Time frame: 24 Weeks
To assess the effectiveness of THIODERM STRONG in reducing the severity of the midface volume deficit in comparison with Juvéderm® VOLUMA® Lidocaine based on Blinded Evaluating Investigator assessment at Week 24 as measured via the 5-point Midface Volume Deficit Severity Scale (MVDSS).
11 secondary outcomes
Total Volume Injected
Time frame: 24 Weeks
Response Rate
Time frame: Day7; Week 4, 8, 16, and 24
Response Magnitude
Time frame: Day 7; Week 4, 8, and 16
Response Magnitude Photographic Review
Time frame: Day7; Week 4, 8, 16, and 24
Aesthetic Improvement via GAIS - Investigator
Time frame: Day7; Week 4, 8, 16, and 24
Aesthetic Improvement via GAIS - Subject
Time frame: Day7; Week 4, 8, 16, and 24
Volume Change via 3D Imaging
Time frame: Day7; Week 4, 8, 16, and 24
Subject Satisfaction - Face-Q(TM) Outcome Scale
Time frame: Day 1, 3, and 7; Week 4, 8, 16, and 24
Subject Appearance Appraisal - Face-Q(TM) Satisfaction with Cheeks
Time frame: Day 1, 3, and 7; Week 4, 8, 16, and 24
Change of Nasolabial Fold Severity
Time frame: Day7; Week 4, 8, 16, and 24
Pain Assessment
Time frame: Day 0; Week 4 (in case of touch-up treatment)
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 12 Dec 2024.
- Individual participant dataSharing planned: No
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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.
Alice Krames-Juerss study director
CROMA Pharma GmbH (Sponsor)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thioderm Strong and Juvéderm VOLUMA Lidocaine in people with Mid Face Volume Deficit, run by Croma-Pharma GmbH at 1 site in Austria.
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 29 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 12 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. 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?
Response Magnitude (time frame: 24 Weeks). 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 12 Dec 2024.