A Study to Assess Adverse Events and Effectiveness of HAC 20L Injections in Adult Participants for the Treatment of Nasolabial Folds

Study Identifier
M21-833
CT.gov Identifier
NCT06018987
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Study Details

Medical Condition
  • Facial Aesthetics - Fillers
    • Study Drug
    N/A
    Phase
    Phase 2/Phase 3
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Has moderate or severe NLFs (NLFSS score 2 or 3) on each NLF based on EI's live assessment (both NLFs must qualify and need to have the same score). * General good health, in the opinion of the TI, and no known current COVID 19 disease or previous COVID-19 disease-related symptoms within 30 days.
    Exclusion Criteria:
    * Atrophic skin in the facial area that makes it unsuitable for injection. * History of anaphylaxis or history or presence of multiple severe allergies, including allergy to antiseptic solution, lidocaine (or any amide-based anesthetics), HA products, human recombinant collagen, bovine or porcine collagen products, gram positive bacterial proteins (including Streptococcal protein) or to any of the excipients. * Prior fat injection or permanent implants (e.g., polymethylmethacrylate, silicone, polytetrafluoroethylene) anywhere in the face, or is planning to be implanted with any of these products at any time during the study. * Received semipermanent soft-tissue filler treatment (e.g., calcium hydroxyapatite, poly-L-lactic acid) in the face below the orbital rim within 24 months before enrollment, or is planning to be implanted with any of these products at any time during the study.

    Protocol Summary

    Nasolabial folds (NLF) are the two skin folds that run from each side of the nose to the corners of the mouth. Prominent NLFs distort the contour of the midface, giving a fatigued and aged appearance. Soft tissue fillers can be used to reduce the depth of NLFs and restore a more youthful appearance. The purpose of this study is to evaluate how safe and effective HAC 20L is in the correction of moderate to severe NLF in adult participants.

    HAC 20L is an investigational drug being developed for the treatment of NLF. There are 2 cohorts in this study. In each cohort participants are assigned to either the treatment group or no-treatment control group. There is a 1 in 3 chance that participants will be assigned to the no-treatment control group. Around 75 adult participants with moderate to severe NLF will be enrolled in the study at approximately 20 sites worldwide.

    Participants in the treatment group will receive an injection of HAC 20L to the NLF on Day 1 in Cohort 1 and Cohort 2 with the option of re-treatment after completion of Month 12 visit. The control group will receive no treatment but will be offered an optional HAC 20L treatment after 6 months.

    There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be examined by completing effectiveness questionnaires by the subjects, evaluating investigator (EI) and central reviewers as well as monitoring safety assessments such as vital signs, blood tests, injection site responses and adverse events.

    Study Locations

    Location
    Status
    Location
    Hautok and Hautok-cosmetics /ID# 254549
    Munich, Bavaria, Germany, 80333
    Status
    Not applicable
    Location
    Dermatologische Gemeinschaftspraxis Mahlow /ID# 232366
    Blankenfelde-Mahlow, Brandenburg, Germany, 15831
    Status
    Not applicable
    Location
    MediCorium Zentrum fuer Dermatologie und Aesthetik /ID# 231403
    Oberursel, Hesse, Germany, 61440
    Status
    Not applicable
    Location
    Hautzentrum Koeln /ID# 231406
    Cologne, North Rhine-Westphalia, Germany, 50996
    Status
    Not applicable
    Location
    Privatpraxis Dr. Hilton & Partner /ID# 231401
    Düsseldorf, North Rhine-Westphalia, Germany, 40212
    Status
    Not applicable
    Location
    CRS Clinical Research Services Berlin GmbH /ID# 240390
    Berlin, Germany, 13627
    Status
    Not applicable
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