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)
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Croma-Pharma GmbH
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Response Magnitude
Overview
Brief 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).
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
- 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 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 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
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).
Secondary Outcomes
- Response Magnitude Photographic Review(Day7; Week 4, 8, 16, and 24)
- Aesthetic Improvement via GAIS - Subject(Day7; Week 4, 8, 16, and 24)
- Subject Satisfaction - Face-Q(TM) Outcome Scale(Day 1, 3, and 7; Week 4, 8, 16, and 24)
- Response Magnitude(Day 7; Week 4, 8, and 16)
- Change of Nasolabial Fold Severity(Day7; Week 4, 8, 16, and 24)
- Pain Assessment(Day 0; Week 4 (in case of touch-up treatment))
- Total Volume Injected(24 Weeks)
- Response Rate(Day7; Week 4, 8, 16, and 24)
- Aesthetic Improvement via GAIS - Investigator(Day7; Week 4, 8, 16, and 24)
- Volume Change via 3D Imaging(Day7; Week 4, 8, 16, and 24)
- Subject Appearance Appraisal - Face-Q(TM) Satisfaction with Cheeks(Day 1, 3, and 7; Week 4, 8, 16, and 24)