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)
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Croma-Pharma GmbH
- Enrollment
- 33
- Locations
- 1
- Primary Endpoint
- Primary Safety Evaluation
Overview
Brief 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.
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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Masking Description
Subjects and Evaluating Investigator will be blinded to study device assignment. The subject will be blind-folded during treatment. The Evaluating Investigator is unaware of the device assignment and has no access to study data that could potentially contain unblinding information
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
- •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.
- •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.
Exclusion Criteria
- •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
- •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
Outcomes
Primary Outcomes
Primary Safety Evaluation
Time Frame: through study completion, an average of 24 weeks
Treatment-emergent AEs related to study treatment.
Secondary Outcomes
- Responder Rate(Day7; Week 4, 8, 16, and 24 and at end of study)
- Safety Evaluation(through study completion, an average of 24 weeks)
- Injection Site Reactions (ISR)(Week 1-4 (Week 1-8 in case of touch-up treatment))
- Required total Volume of Injection(Day 0; Week 4 (in case of touch-up treatment))
- Magnitude of Response Both Lips (Independent Photo Review Panel)(Day7; Week 4, 8, 12, 16, and 24)
- Responder Rate Week 12(Week 12)
- Magnitude of Response Upper Lip (Investigator)(Day7; Week 4, 8, 12, 16, and 24)
- Magnitude of Response Both Lips (Investigator)(Day7; Week 4, 8, 12, 16, 24 and End of Study)
- Magnitude of Response Lower Lip (Investigator)(Day7; Week 4, 8, 12, 16, 24 and End of Study)
- Magnitude of Response Upper Lip (Independent Photo Review Panel)(Day7; Week 4, 8, 12, 16, and 24)
- Aesthetic Improvement (Investigator)(Week 4, 8, 12, 16, 24 and end of stidy)
- Pain Assessment(Day 0; Week 4 (in case of touch-up treatment))
- Magnitude of Response Lower Lip (Independent Photo Review Panel)(Day7; Week 4, 8, 12, 16, and 24)
- Aesthetic Improvement (Subject)(Week 4, 8, 12, 16, 24 and end od study)
- Lip Volume Change(Week 4, 8, 12, 16, 24 and end of study)
- Subject's satisfaction (Outcome)(Day 1, 3, 7 and Week 4, 8,12, 16, 24 and end of study)
- Subject's satisfaction (Lips)(Day 1, 3, 7 and Week 4, 8,12, 16 24 and end of study)