Clinical trial NCT06018987: A Study to Assess Adverse Events and Effectiveness of HAC 20L Injections in Adult Participants for the Treatment of Nasolabial Folds
Official title: A Multicenter, Evaluator-blinded, Randomized, Delayed Treatment Control Group Study of the Safety and Effectiveness of HAC 20L for the Correction of Moderate to Severe Nasolabial Folds
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Nasolabial Folds
Keywords: HAC 20L
AGN-8010
Nasolabial Folds
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2023-08-31
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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. 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 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.

Primary outcomes:
measure: Percentage of Participants Achieving Responder Status Based on Evaluating Investigator's (EI's) Live Assessment of Nasolabial Folds (NLF) Severity using the Nasolabial Fold Severity Scale (NLFSS)
timeFrame: Month 6
measure: Number of Participants with Adverse Events (AEs)
timeFrame: Month 16
Secondary outcomes:
measure: Change from Baseline on the Overall Score of FACE-Q-Appraisal of Lines: Nasolabial Folds Questionnaire
timeFrame: Baseline to Month 6
measure: Percentage of Participants Achieving Responder Status Based on Evaluating Investigator's Assessment of Global Aesthetic Improvement on the NLF Area using the Global Aesthetic Improvement Scale (GAIS)
timeFrame: Month 6
measure: Percentage of Participants Achieving Responder Status Based on Participant's Assessment of Global Aesthetic Improvement in the NLF Area Using the GAIS
timeFrame: Month 6
Other outcomes:
Locations:
city: Muenchen
country: Germany
facility: Hautok and Hautok-cosmetics /ID# 254549
state: Bayern
city: Blankenfelde-Mahlow
country: Germany
facility: Dermatologische Gemeinschaftspraxis Mahlow /ID# 232366
state: Brandenburg
city: Oberursel
country: Germany
facility: MediCorium Zentrum fuer Dermatologie und Aesthetik /ID# 231403
state: Hessen
city: Duesseldorf
country: Germany
facility: Privatpraxis Dr. Hilton & Partner /ID# 231401
state: Nordrhein-Westfalen
city: Koeln
country: Germany
facility: Hautzentrum Koeln /ID# 231406
state: Nordrhein-Westfalen
city: Berlin
country: Germany
facility: CRS Clinical Research Services Berlin GmbH /ID# 240390
city: Düsseldorf
country: Germany
facility: Dermatologie am Luegplatz /ID# 233788
city: Hamburg
country: Germany
facility: Universitaet Hamburg /ID# 231641
city: Kassel
country: Germany
facility: Noahklinik GmbH /ID# 231917
city: Muenchen
country: Germany
facility: Privatpraxis fuer Dermatologie und Aesthetik /ID# 231402
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: