CompletedNot Applicable

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

Austria33 participantsStarted 2023-06-01

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. 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).

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

What they're measuring

Primary Safety Evaluation

Timeframe: through study completion, an average of 24 weeks

Trial details

NCT IDNCT06135337

SponsorCroma-Pharma GmbH

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-01-10

View on ClinicalTrials.gov More Lip Abnormality trials