THIODERM STRONG Compared to Juvéderm® VOLUMA® Lidocaine for the Treatment of Midface Volume Deficit

NCT06128109 | Completed

• 1 other identifier: CPH-50501
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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).

Conditions

Mid Face Volume Deficit

Keywords

Midface; Volume Deficit; Hyaluronic Acid; Dermal Filler

Outcome Measures

Primary Outcomes (1)

• 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).

  24 Weeks

Secondary Outcomes (11)

• Total Volume Injected

  24 Weeks

• Response Rate

  Day7; Week 4, 8, 16, and 24

• Response Magnitude

  Day 7; Week 4, 8, and 16

• Response Magnitude Photographic Review

  Day7; Week 4, 8, 16, and 24

• Aesthetic Improvement via GAIS - Investigator

  Day7; Week 4, 8, 16, and 24

Other Outcomes (1)

• Safety Evaluation

  through study completion, an average of 24 weeks

Study Arms (2)

Group THIODERM LEFT

OTHER

Split Face Design: Test Device left midface and Comparator Device right midface

Device: Thioderm Strong; Device: Juvéderm VOLUMA Lidocaine

Group JUVÈDERM LEFT

OTHER

Split Face Design: Test Device right midface and Comparator Device left midface

Device: Thioderm Strong; Device: Juvéderm VOLUMA Lidocaine

Interventions

Thioderm Strong DEVICE

Test Device

Group JUVÈDERM LEFT; Group THIODERM LEFT

Juvéderm VOLUMA Lidocaine DEVICE

Comparator Device

Group JUVÈDERM LEFT; Group THIODERM LEFT

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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).

Sponsors & Collaborators

• Croma-Pharma GmbH: lead
• Proinnovera GmbH: collaborator

Study Sites (1)

H&P Ambulatorien GmbH

Vienna, 1010, Austria

Location

Study Officials

• Alice Krames-Juerss

  CROMA Pharma GmbH (Sponsor)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Split-Face Design with random assignment of test device and comparator device to be injected either into right or into left Mid Face Area

Study Record Dates

• First Submitted: November 3, 2023
• First Posted: November 13, 2023
• Study Start: January 24, 2023
• Primary Completion: August 28, 2023
• Study Completion: January 9, 2024
• Last Updated: December 12, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)