THIODERM ELATE for Volume Augmentation in Lips

Launched by CROMA-PHARMA GMBH · Nov 9, 2023

Keywords

ClinConnect Summary

The clinical investigation will comprise randomization to one of two treatment groups:

* Test device: THIODERM ELATE
* Comparator device: Juvéderm® ULTRA 3 The Screening visit (Visit 1) will be performed within 2 weeks prior to randomization and will entail informed consent and screening assessments. During this visit the treating investigator will determine eligibility of subjects based on study inclusion and exclusion criteria - except for Baseline severity of lip volume deficit, that will be determined at Screening visit (Visit 1) by the blinded evaluator at the site using the 5-point L...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Male or female subjects aged 18-75 years (inclusive) of age at Screening (Visit 1).
• • 2. Subjects with approximately symmetric moderate to severe lip volume deficit (severity scores of 1, 2, or 3 on the 5-point Lip Fullness Scale), as assessed by the blinded evaluator at the site. Approximately symmetric is defined as a maximum of 1 grade difference between upper and lower lip. Both lips need to meet the eligibility criterion of severity score 1, 2 or 3 on the 5-point LFS.
• • 3. 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 investigation.
• • 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).
• • 4. Healthy skin in and around the treatment area and free of diseases that could interfere in the effectiveness assessments.
• • 5. Intact or permanently replaced incisor and canine teeth in the upper and lower jaw.
• • 6. Willingness to abstain from any aesthetic or surgical procedures in the treatment area for the duration of the entire investigation.
• • 7. 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 treating investigator.
• Exclusion Criteria:
• Subjects who meet ANY of the following criteria are NOT eligible for the clinical investigation and must not be enrolled:
• • 1. Females, who are pregnant and/or, lactating or planning to become pregnant during the clinical investigation.
• • 2. History of allergy or hypersensitivity to hyaluronic acid preparations, lidocaine or any amide-based anesthetic.
• • 3. Prior surgery, scars or tattoo to the upper or lower lip or lip line; surgery and tattooing are prohibited until end of clinical investigation.
• • 4. Tooth gap, overbite, beard longer three-day beard, or excessive facial hair that could interfere in evaluation of treatment as judged by the treating investigator.
• • Note: If subject agrees to shave beard, incl. three-day beard, or excessive facial hair prior to on-site visits, the subject is eligible for the investigation.
• • 5. Presence of any abnormal lip structure, such as a scar or lump or severe lip asymmetry, as judged by the treating investigator.
• • 6. Presence of infectious, inflammatory or proliferative cancerous or pre-cancerous lesions in the treatment area.
• • 7. Re-current (at least three times over the last year) herpes simplex in the treatment area.
• • 8. History or presence of the following autoimmune or connective tissue diseases: Scleroderma, advanced Lupus erythematosus that is unstable, acute rheumatic fever with heart complications.
• • 9. AIDS that is not well controlled as determined by the treating investigator.
• • 10. Uncontrolled (or unstable) Diabetes mellitus or uncontrolled / unstable other systemic diseases as per treating investigator discretion.
• • 11. Implantation of HA or collagen dermal fillers in the treatment area within the preceding 18 months prior to Screening (Visit 1) and during the entire investigation.
• • 12. Previous permanent implant or treatment with non-HA or non-collagen filler in or around the lip area (including lips, oral commissures, nasolabial folds, marionette, and perioral lines) and until end of the investigation.
• • 13. Previous botulinum toxin treatment in or around the lip area (including lips, oral commissures, nasolabial folds, marionette, and perioral lines) within 12 months before Screening (Visit 1) and until end of clinical investigation.
• • 14. 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) or non-absorbable sutures in the area of device application and during the entire investigation.
• 15. Subject has received any of the following treatments:
• • Full ablative facial laser therapy,
• • Absorbable sutures (threads) in the treatment area,
• • Facial lipolysis, including submental fat treatments or
• • Bariatric surgery within the last 12 months prior to Screening (Visit 1) or is planning to undergo such procedures during entire investigation.
• • 16. Subject has received dermabrasion, mesotherapy, chemical peeling, or micro-needling in the face within 30 days prior to baseline treatment and touch-up treatment.
• 17. The use of the following anticoagulant or thrombolytic medications is not allowed from ten days pre- to three days post injection (baseline treatment):
• • Vitamin K Antagonists (e.g., Warfarin)
• • Oral Direct Factor Xa Inhibitors (e.g., Apixaban, Betrixaban, Edoxaban, Rivaroxaban)
• • Oral Direct Factor IIa Inhibitors (e.g., Dabigatran)
• • 18. Planned dental/oral surgery or modification (bridge-work, implants) within four weeks prior to each injection and to a minimum of four weeks post injection baseline treatment and touch-up treatment.
• • 19. Subjects who have one of the following assessments during the visual examinations at Screening (Visit 1): Snellen visual acuity test worse than 20/40 (with corrective eyewear, if applicable), abnormal confrontational visual field test, or abnormal ocular motility test.
• • 20. Any medical condition prohibiting the inclusion in the study according to the judgment of the treating investigator.
• • 21. Previous enrollment in this clinical investigation.
• • 22. Current participation in another clinical trial, or treatment with any investigational drug/medical device within 30 days prior to Screening (Visit 1) or within five half-lives of an investigational drug, whichever is longer and during the entire investigation.
• • 23. 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.
• • 24. 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).
• • 25. 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.