Lip AbnormalityTILINCT06135337
THIODERM ELATE for Augmentation of Very Thin, Thin, and Moderately Thick Lips
A study testing Thioderm Elate and Juvéderm Ultra 3 in people with Lip Abnormality, run by Croma-Pharma GmbH at 1 site in Austria.
Trial summary
This mono-center clinical investigation is intended to assess the safety and effectiveness of THIODERM ELATE for augmentation of very thin and thin lips in comparison with Juvéderm® Ultra 3. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lip Abnormality
- What is being tested?
- Thioderm Elate and Juvéderm Ultra 3
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteAustria
- Study dates
- 1 Jun 2023to 9 Sep 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 approximately symmetrical 'very thin' or 'thin' lips (scores of 1 or 2 on the 5-point Lip Fullness Scale) as assessed by the Blinded Evaluating Investigator at Screening (Visit 0). The scores do not have to be the same on both (upper and lower) lips, but must be 1 or 2.
- Healthy skin in the perioral area and free of diseases that could interfere in cutaneous aging evaluation.
- Intact or permanently replaced central and lateral incisors, canine and first and second premolars in the upper row of teeth and intact or replaced incisors, canines and premolars in the lower row of teeth
- 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 study.
Show all 9Show fewer
- 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 28Show 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 perioral area and or lower face third: 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) as well as permanent make-up at the lips within the last 12 months prior to Visit 0, chemical peeling within the last three months prior to Visit 0 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 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.
- Subjects suffering from untreated epilepsy.
- Subjects with acute rheumatic fever with heart complications.
- Subjects 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-19 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 enrolment, or 5 half-lives of the investigational drug, whichever is longer.
- Subjects who experienced fat loss for a minimum of 10% of body weight over the last 12 months (e.g., post bariatric subjects), 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: A Prospective, Exploratory, Randomized, Subject- and Evaluator - Blinded, Parallel- Group, Single-centre, Pilot Trial Investigating the Safety and Effect of THIODERM ELATE Compared to Juvéderm® Ultra 3 for Lip Augmentation (TILI)
This mono-center clinical investigation is intended to assess the safety and effectiveness of THIODERM ELATE for augmentation of very thin and thin lips in comparison with Juvéderm® Ultra 3.
Read the detailed description
The Investigation is a prospective, exploratory, randomized, subject and evaluator - blinded, parallel-group, single-centre, pilot trial investigating the safety and effectiveness of THIODERM ELATE compared to Juvéderm® Ultra 3 for lip augmentation. Up to 33 eligible subjects will be included in this investigation with a 10 % estimated drop-out rate and will be randomized in a 2:1 ratio to Thioderm ELATE and Juvéderm® Ultra 3, respectively, after the informed consent form (ICF) has been signed and relevant pre-treatment procedures, including medical history and pregnancy testing, as well as eligibility for inclusion have been performed. Subjects will receive injections into both, upper and lower lip using Thioderm ELATE or Juvéderm® Ultra 3 until an optimal cosmetic result is achieved. During Screening and prior to injection, the Blinded Evaluating Investigator will evaluate the lip fullness by using the 5-point Lip Fullness Scale (LFS). An optional touch-up treatment can be performed at Week 4 upon discretion of the treating investigator. The safety and effectiveness of the treatment will be evaluated after Day 1, 3 and 7 as well as at 4, 8,12, 16 and 24 weeks or an End of Study Visit using objective and subjective outcome parameters. . The same Blinded Evaluating Investigator will assess each subject at screening and at the follow-up visits.
- Conditions
- Lip Abnormality
- Being tested
- Thioderm Elate, Juvéderm Ultra 3
- Keywords
- Lips, 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 ElateDevice
Test Device
Juvéderm Ultra 3Device
Active Comparator Device
| Study group | Role | What they receive |
|---|---|---|
| Group THIODERM ELATE | Experimental | Subjects who will receive THIODERM ELATE into upper and lower lip (66.7% of enrolled subjects) Receives: Device: Thioderm Elate |
| Group JUVÉDERM ULTRA 3 | Active comparator | Subjects who will receive JUVÉDERM ULTRA 3 into upper and lower lip (33.3% of enrolled subjects) Receives: Device: Juvéderm Ultra 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety Evaluation
Treatment-emergent AEs related to study treatment.
Measured: through study completion, an average of 24 weeks
Secondary outcomes (17)
Safety Evaluation
Frequency, severity, and causal relationship of adverse events (AEs) and serious adverse events (SAEs) during the entire study period, including adverse device effects (ADEs) and serious adverse device effects (SADEs)
Measured: through study completion, an average of 24 weeks
Injection Site Reactions (ISR)
Injection site reactions as recorded in the Subject diaries during the first 4 weeks (28 days) after baseline- or touch-up-treatment. Injection site reactions will be assessed overall
Measured: Week 1-4 (Week 1-8 in case of touch-up treatment)
Responder Rate Week 12
Response measured on the 5-point LFS at Week 12 compared to baseline, based on the Blinded Evaluating Investigator's live assessment where responder is defined as a subject with a ≥1 improvement of the upper lip AND a ≥1 improvement of the lower lip
Measured: Week 12
Required total Volume of Injection
Required total volume for optimum aesthetic result for treatment of the lip volume deficit at baseline and optional touch - up treatment at Week 4 of the upper and lower lip, as well as for the lip overall.
Measured: Day 0; Week 4 (in case of touch-up treatment)
Responder Rate
Response measured on the 5-point LFS at Day 7 and Week 4, 8, 16, 24 and End of Study compared to baseline, based on the Blinded Evaluating Investigator's live assessment where a responder is defined as a Subject with a ≥1 improvement on the upper lip AND a ≥ 1 improvement on the lower lip on the 5-point LFS
Measured: Day7; Week 4, 8, 16, and 24 and at end of study
Magnitude of Response Upper Lip (Investigator)
Change of 5-point LFS of the upper lip from baseline to Day 7 and Week 4, 8, 12, 16, 24 and at End of Study based on the Blinded Evaluating Investigator's live assessment
Measured: Day7; Week 4, 8, 12, 16, and 24
Magnitude of Response Lower Lip (Investigator)
Change of 5-point LFS of the lower lip from baseline to Day 7 and Week 4, 8, 12, 16 and 24and at end of study based on the Blinded Evaluating Investigator's live assessment
Measured: Day7; Week 4, 8, 12, 16, 24 and End of Study
Magnitude of Response Both Lips (Investigator)
Change of 5-point LFS of the overall lip from baseline to Day 7 and Week 4, 8, 12, 16 and 24 and at end of study based on the Blinded Evaluating Investigator's live assessment
Measured: Day7; Week 4, 8, 12, 16, 24 and End of Study
Magnitude of Response Upper Lip (Independent Photo Review Panel)
Change of 5-point LFS of the upper lip from baseline to Day 7 and Week 4, 8, 12, 16 and 24 based on the independent blinded evaluating panel's assessment
Measured: Day7; Week 4, 8, 12, 16, and 24
Magnitude of Response Lower Lip (Independent Photo Review Panel)
Change of 5-point LFS of the lower lip from baseline to Day 7 and Week 4, 8, 12, 16 and 24 based on the independent blinded evaluating panel's assessment
Measured: Day7; Week 4, 8, 12, 16, and 24
Magnitude of Response Both Lips (Independent Photo Review Panel)
Change of 5-point LFS of the overall lip from baseline to Day 7 and Week 4, 8, 12, 16 and 24 based on the independent blinded evaluating panel's assessment
Measured: Day7; Week 4, 8, 12, 16, and 24
Aesthetic Improvement (Investigator)
Aesthetic improvement based on the Blinded Evaluating Investigator's assessment at Week 4, 8,12, 16 and 24 and at end of study using the GAIS
Measured: Week 4, 8, 12, 16, 24 and end of stidy
Aesthetic Improvement (Subject)
Aesthetic improvement based on the Subject's assessment at Week 4, 8,12, 16 and 24 and at end of study using the GAIS
Measured: Week 4, 8, 12, 16, 24 and end od study
Lip Volume Change
Volume change of the lips at Day 7 and Week 4, 8,12, 16 and 24 and at end of study, based on 3D surface imaging in comparison to the baseline 3D image
Measured: Week 4, 8, 12, 16, 24 and end of study
Subject's satisfaction (Outcome)
The extent of subject´s satisfaction with treatment of the lips at Day 1, 3, 7 and Week 4, 8,12, 16 and 24 and at ebd of study as assessed by the FACE-Q(TM) Satisfaction with Outcome Scale
Measured: Day 1, 3, 7 and Week 4, 8,12, 16, 24 and end of study
Subject's satisfaction (Lips)
The extent of subject´s appearance appraisal at Day 1, 3, 7 and Week 4, 8,12, 16 and 24 and at end of study as assessed by the FACE-QTM Satisfaction with Lip Scale
Measured: Day 1, 3, 7 and Week 4, 8,12, 16 24 and end of study
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
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 posted18 Nov 2023
- Study start1 Jun 2023
- Primary completion10 Jan 2024
- Study completion9 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lip AbnormalityStudies 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
- Parallel-Group Design with random assignment to test device or comparator device in a 2:1 ratio
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Croma-Pharma GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Proinnovera GmbH
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06135337
- Sponsor's protocol ID
- CPH-70601
- Acronym
- TILI
- Status last verified
- Dec 2024
- First submitted
- 10 Nov 2023
- Last updated
- 13 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 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Exploratory, Randomized, Subject- and Evaluator - Blinded, Parallel- Group, Single-centre, Pilot Trial Investigating the Safety and Effect of THIODERM ELATE Compared to Juvéderm® Ultra 3 for Lip Augmentation (TILI)
- ClinicalTrials.gov ID
- NCT06135337
- Acronym / sponsor ID
- TILI / CPH-70601
- Conditions
- Lip Abnormality
- Keywords
- Lips, Volume Deficit, Hyaluronic Acid, Dermal Filler
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Croma-Pharma GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Proinnovera GmbH
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 10 Jan 2024 (actual)
- Study completion
- 9 Sep 2024 (actual)
- First posted
- 18 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 assess the safety and effectiveness of THIODERM ELATE for augmentation of very thin and thin lips in comparison with Juvéderm® Ultra 3.
Detailed description
The Investigation is a prospective, exploratory, randomized, subject and evaluator - blinded, parallel-group, single-centre, pilot trial investigating the safety and effectiveness of THIODERM ELATE compared to Juvéderm® Ultra 3 for lip augmentation. Up to 33 eligible subjects will be included in this investigation with a 10 % estimated drop-out rate and will be randomized in a 2:1 ratio to Thioderm ELATE and Juvéderm® Ultra 3, respectively, after the informed consent form (ICF) has been signed and relevant pre-treatment procedures, including medical history and pregnancy testing, as well as eligibility for inclusion have been performed. Subjects will receive injections into both, upper and lower lip using Thioderm ELATE or Juvéderm® Ultra 3 until an optimal cosmetic result is achieved. During Screening and prior to injection, the Blinded Evaluating Investigator will evaluate the lip fullness by using the 5-point Lip Fullness Scale (LFS). An optional touch-up treatment can be performed at Week 4 upon discretion of the treating investigator. The safety and effectiveness of the treatment will be evaluated after Day 1, 3 and 7 as well as at 4, 8,12, 16 and 24 weeks or an End of Study Visit using objective and subjective outcome parameters. . The same Blinded Evaluating Investigator will assess each subject at screening and at the follow-up visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel-Group Design with random assignment to test device or comparator device in a 2:1 ratio
| Arm | Type | Receives |
|---|---|---|
| Group THIODERM ELATE | Experimental | Device: Thioderm ElateSubjects who will receive THIODERM ELATE into upper and lower lip (66.7% of enrolled subjects) |
| Group JUVÉDERM ULTRA 3 | Active comparator | Device: Juvéderm Ultra 3Subjects who will receive JUVÉDERM ULTRA 3 into upper and lower lip (33.3% of enrolled subjects) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Aged ≥ 18 years at the time of screening (upper limit 75 years, inclusive).
- Subjects with approximately symmetrical 'very thin' or 'thin' lips (scores of 1 or 2 on the 5-point Lip Fullness Scale) as assessed by the Blinded Evaluating Investigator at Screening (Visit 0). The scores do not have to be the same on both (upper and lower) lips, but must be 1 or 2.
- Healthy skin in the perioral area and free of diseases that could interfere in cutaneous aging evaluation.
- Intact or permanently replaced central and lateral incisors, canine and first and second premolars in the upper row of teeth and intact or replaced incisors, canines and premolars in the lower row of teeth
- Subject has a stable medical condition with no uncontrolled systemic disease.
Key exclusion criteria (28 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 ElateTest Device | Device | Group THIODERM ELATE |
| Juvéderm Ultra 3Active Comparator Device | Device | Group JUVÉDERM ULTRA 3 |
Primary outcome
Primary Safety Evaluation
Time frame: through study completion, an average of 24 weeks
Treatment-emergent AEs related to study treatment.
17 secondary outcomes
Safety Evaluation
Time frame: through study completion, an average of 24 weeks
Injection Site Reactions (ISR)
Time frame: Week 1-4 (Week 1-8 in case of touch-up treatment)
Responder Rate Week 12
Time frame: Week 12
Required total Volume of Injection
Time frame: Day 0; Week 4 (in case of touch-up treatment)
Responder Rate
Time frame: Day7; Week 4, 8, 16, and 24 and at end of study
Magnitude of Response Upper Lip (Investigator)
Time frame: Day7; Week 4, 8, 12, 16, and 24
Magnitude of Response Lower Lip (Investigator)
Time frame: Day7; Week 4, 8, 12, 16, 24 and End of Study
Magnitude of Response Both Lips (Investigator)
Time frame: Day7; Week 4, 8, 12, 16, 24 and End of Study
Magnitude of Response Upper Lip (Independent Photo Review Panel)
Time frame: Day7; Week 4, 8, 12, 16, and 24
Magnitude of Response Lower Lip (Independent Photo Review Panel)
Time frame: Day7; Week 4, 8, 12, 16, and 24
Magnitude of Response Both Lips (Independent Photo Review Panel)
Time frame: Day7; Week 4, 8, 12, 16, and 24
Aesthetic Improvement (Investigator)
Time frame: Week 4, 8, 12, 16, 24 and end of stidy
Aesthetic Improvement (Subject)
Time frame: Week 4, 8, 12, 16, 24 and end od study
Lip Volume Change
Time frame: Week 4, 8, 12, 16, 24 and end of study
Subject's satisfaction (Outcome)
Time frame: Day 1, 3, 7 and Week 4, 8,12, 16, 24 and end of study
Subject's satisfaction (Lips)
Time frame: Day 1, 3, 7 and Week 4, 8,12, 16 24 and end of study
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 13 Dec 2024.
- Individual participant dataSharing planned: No
Related trials for Lip Abnormality
Not yet recruiting
970-nm Diode Laser Versus Liquid Nitrogen Cryotherapy in Maxillary Labial Frenectomy
Maxillary Labial Frenulum Abnormality, Hypertrophic Maxillary Labial Frenulum
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.
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 Elate and Juvéderm Ultra 3 in people with Lip Abnormality, 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 9 inclusion and 28 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 13 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?
Primary Safety Evaluation (time frame: through study completion, an average of 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 13 Dec 2024.