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

Last updated: February 10, 2025
Sponsor: AbbVie
Overall Status: Completed

Phase

2/3

Condition

N/A

Treatment

HAC 20L

No-Treatment Control

Clinical Study ID

NCT06018987
M21-833
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Has moderate or severe NLFs (NLFSS score 2 or 3) on each NLF based on EI's liveassessment (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 diseaseor previous COVID-19 disease-related symptoms within 30 days.

Exclusion

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-basedanesthetics), HA products, human recombinant collagen, bovine or porcine collagenproducts, gram positive bacterial proteins (including Streptococcal protein) or toany of the excipients.

  • Prior fat injection or permanent implants (e.g., polymethylmethacrylate, silicone,polytetrafluoroethylene) anywhere in the face, or is planning to be implanted withany 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 beforeenrollment, or is planning to be implanted with any of these products at any timeduring the study.

Study Design

Total Participants: 61
Treatment Group(s): 2
Primary Treatment: HAC 20L
Phase: 2/3
Study Start date:
September 05, 2023
Estimated Completion Date:
February 03, 2025

Connect with a study center

  • Hautok and Hautok-cosmetics /ID# 254549

    Muenchen, Bayern 80333
    Germany

    Site Not Available

  • Dermatologische Gemeinschaftspraxis Mahlow /ID# 232366

    Blankenfelde-Mahlow, Brandenburg 15831
    Germany

    Site Not Available

  • MediCorium Zentrum fuer Dermatologie und Aesthetik /ID# 231403

    Oberursel, Hessen 61440
    Germany

    Site Not Available

  • Privatpraxis Dr. Hilton & Partner /ID# 231401

    Duesseldorf, Nordrhein-Westfalen 40212
    Germany

    Site Not Available

  • Hautzentrum Koeln /ID# 231406

    Koeln, Nordrhein-Westfalen 50996
    Germany

    Site Not Available

  • CRS Clinical Research Services Berlin GmbH /ID# 240390

    Berlin, 13627
    Germany

    Site Not Available

  • Dermatologie am Luegplatz /ID# 233788

    Düsseldorf, 40545
    Germany

    Site Not Available

  • Universitaet Hamburg /ID# 231641

    Hamburg, 20146
    Germany

    Site Not Available

  • Noahklinik GmbH /ID# 231917

    Kassel, 34117
    Germany

    Site Not Available

  • Dermatologische Gemeinschaftspraxis Mahlow /ID# 232366

    Mahlow, 15831
    Germany

    Site Not Available

  • Privatpraxis fuer Dermatologie und Aesthetik /ID# 231402

    Muenchen, 80539
    Germany

    Site Not Available

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