NCT06135337

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

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)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Croma-Pharma GmbH · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lip Abnormality

Interventions

Type	Name	Description
DEVICE	Thioderm Elate	Test Device
DEVICE	Juvéderm Ultra 3	Active Comparator Device

Timeline

• Start date: 2023-06-01
• Primary completion: 2024-01-10
• Completion: 2024-09-09
• First posted: 2023-11-18
• Last updated: 2024-12-13

Locations

1 site across 1 country: Austria