THIODERM ELATE for Augmentation of Very Thin, Thin, and Moderately Thick Lips

NCT06135337 | Completed

• 1 other identifier: CPH-70601
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Lip Abnormality

Keywords

Lips; Volume Deficit; Hyaluronic Acid; Dermal Filler

Outcome Measures

Primary Outcomes (1)

• Primary Safety Evaluation

  Treatment-emergent AEs related to study treatment.

  through study completion, an average of 24 weeks

Secondary Outcomes (17)

• 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)

• Responder Rate Week 12

  Week 12

• Required total Volume of Injection

  Day 0; Week 4 (in case of touch-up treatment)

• Responder Rate

  Day7; Week 4, 8, 16, and 24 and at end of study

Study Arms (2)

Group THIODERM ELATE

EXPERIMENTAL

Subjects who will receive THIODERM ELATE into upper and lower lip (66.7% of enrolled subjects)

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)

Device: Juvéderm Ultra 3

Interventions

Thioderm Elate DEVICE

Test Device

Group THIODERM ELATE

Juvéderm Ultra 3 DEVICE

Active Comparator Device

Group JUVÉDERM ULTRA 3

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 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.
• 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 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).

Sponsors & Collaborators

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

Study Sites (1)

H&P Ambulatorien GmbH

Vienna, 1010, Austria

Location

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: Parallel-Group Design with random assignment to test device or comparator device in a 2:1 ratio

Study Record Dates

• First Submitted: November 10, 2023
• First Posted: November 18, 2023
• Study Start: June 1, 2023
• Primary Completion: January 10, 2024
• Study Completion: September 9, 2024
• Last Updated: December 13, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)