Status:
COMPLETED
A Study to Assess Adverse Events and Effectiveness of HAC 20L Injections in Adult Participants for the Treatment of Nasolabial Folds
Lead Sponsor:
AbbVie
Conditions:
Nasolabial Folds
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief 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....
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 5 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 3 2025
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT06018987
Start Date
September 5 2023
End Date
February 3 2025
Last Update
February 11 2025
Active Locations (10)
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1
Hautok and Hautok-cosmetics /ID# 254549
Munich, Bavaria, Germany, 80333
2
Dermatologische Gemeinschaftspraxis Mahlow /ID# 232366
Blankenfelde-Mahlow, Brandenburg, Germany, 15831
3
MediCorium Zentrum fuer Dermatologie und Aesthetik /ID# 231403
Oberursel, Hesse, Germany, 61440
4
Hautzentrum Koeln /ID# 231406
Cologne, North Rhine-Westphalia, Germany, 50996