THIODERM ELATE for Volume Augmentation in Lips

NCT06133153 | Withdrawn

• 1 other identifier: CPH-70602
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

A pivotal, randomized, subject- and evaluator-blinded, controlled, non-inferiority, multicenter, parallel group comparison study to evaluate effectiveness and safety of THIODERM ELATE for lip augmentation in order to correct lip volume deficit

Conditions

Lip; Anomaly

Keywords

Lip Volume Deficit; Hyaluronic Acid Filler; Lip Augmentation; Dermal Filler

Outcome Measures

Primary Outcomes (1)

• Change in Lip Volume from Baseline

  Changes from baseline in LFS scores of the upper and lower lips based on the blinded evaluator´s live assessment at Week 12 after last injection of initial treatment phase.

  Week 12

Secondary Outcomes (9)

• Subject's assessment of Aesthetic Improvement

  Week 12

• Response Rate

  Weeks 8, 24, and 36.

• Change in Lip Volume from Baseline

  Weeks 8, 24, and 36.

• Global Aesthetic Improvement over baseline - Subject

  Weeks 8, 24, and 36.

• Global Aesthetic Improvement over baseline - Blinded Evaluator

  Weeks 8, 24, and 36.

Other Outcomes (2)

• Safety Endpoint: Adverse Events

  through study completion, an average of 36 Weeks

• Safety Endpoint: Injection Site Reactions (ISR)

  Day 0; Week 4

Study Arms (2)

Arm THIODERM ELATE

EXPERIMENTAL

Subjects randomized to Arm A (approx. 66.7% of subjects) will receive THIODERM ELATE injected into both lips (Experimental Device) at the initial treatment and a potential touchup treatment.

Device: THIODERM ELATE

Arm JUVÉDERM ULTRA

ACTIVE COMPARATOR

Subjects randomized to Arm A (approx. 33.3% of subjects) will receive Juvéderm(R) Ultra injected into both lips (Comparator Device) at the initial treatment and a potential touchup treatment. .

Device: Juvéderm Ultra 3

Interventions

THIODERM ELATE DEVICE

Thiomer-crosslinked Hyaluronic Acid Dermal Filler with Lidocaine for Injection into Lips

Arm THIODERM ELATE

Juvéderm Ultra 3 DEVICE

BDDE-crosslinked Hyaluronic Acid Dermal Filler with Lidocaine for Injection into Lips

Arm JUVÉDERM ULTRA

Eligibility Criteria

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

You may qualify if:

• Male or female subjects aged 18-75 years (inclusive) of age at Screening (Visit 1).
• \. 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.
• \. 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).
• \. Healthy skin in and around the treatment area and free of diseases that could interfere in the effectiveness assessments.
• \. Intact or permanently replaced incisor and canine teeth in the upper and lower jaw.
• \. Willingness to abstain from any aesthetic or surgical procedures in the treatment area for the duration of the entire investigation.
• \. 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.

You may not qualify if:

• Subjects who meet ANY of the following criteria are NOT eligible for the clinical investigation and must not be enrolled:
• Females, who are pregnant and/or, lactating or planning to become pregnant during the clinical investigation.
• History of allergy or hypersensitivity to hyaluronic acid preparations, lidocaine or any amide-based anesthetic.
• Prior surgery, scars or tattoo to the upper or lower lip or lip line; surgery and tattooing are prohibited until end of clinical investigation.
• 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.
• Presence of any abnormal lip structure, such as a scar or lump or severe lip asymmetry, as judged by the treating investigator.
• Presence of infectious, inflammatory or proliferative cancerous or pre-cancerous lesions in the treatment area.
• Re-current (at least three times over the last year) herpes simplex in the treatment area.
• History or presence of the following autoimmune or connective tissue diseases: Scleroderma, advanced Lupus erythematosus that is unstable, acute rheumatic fever with heart complications.
• AIDS that is not well controlled as determined by the treating investigator.
• Uncontrolled (or unstable) Diabetes mellitus or uncontrolled / unstable other systemic diseases as per treating investigator discretion.
• 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.
• 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.
• 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.

Sponsors & Collaborators

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

Study Sites (1)

H&P Ambulatorien GmbH

Vienna, 1010, Austria

Location

MeSH Terms

Conditions

Lymphoid Interstitial Pneumonia; Congenital Abnormalities

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Subjects will be blinfolded during treatments; the blinded evaluating investigator will be blinded to device allocation and will have no access to unblinding information in the study files
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel-Group randomized study with a randomization ratio of 2:1 (Study Device : Comparator Device)

Study Record Dates

• First Submitted: November 3, 2023
• First Posted: November 15, 2023
• Study Start: March 1, 2024
• Primary Completion: August 1, 2025
• Study Completion: April 1, 2026
• Last Updated: December 11, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)