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

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

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 255 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 Overview

• Status: Recruiting
• Conditions: Nasolabial Folds
• Intervention / Treatment: Device: HAC 20L; Other: No-Treatment Control

• Study Type: Interventional
• Enrollment (Estimated): 255
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: ABBVIE CALL CENTER; Phone Number: 844-663-3742; Email: abbvieclinicaltrials@abbvie.com

Study Locations

• Germany
  • Berlin, Germany, 13627
    • Recruiting
    • CRS Clinical Research Services Berlin GmbH /ID# 240390
  • Düsseldorf, Germany, 40545
    • Recruiting
    • Dermatologie am Luegplatz /ID# 233788
  • Hamburg, Germany, 20146
    • Recruiting
    • Universitaet Hamburg /ID# 231641
  • Kassel, Germany, 34117
    • Recruiting
    • Noahklinik GmbH /ID# 231917
  • Mahlow, Germany, 15831
    • Recruiting
    • Dermatologische Gemeinschaftspraxis Mahlow /ID# 232366
  • Muenchen, Germany, 80333
    • Recruiting
    • Hautok and Hautok-cosmetics /ID# 254549
  • Muenchen, Germany, 80539
    • Recruiting
    • Privatpraxis fuer Dermatologie und Aesthetik /ID# 231402
  • Oberursel, Germany, 61440
    • Recruiting
    • MediCorium Zentrum fuer Dermatologie und Aesthetik /ID# 231403
  • Nordrhein-Westfalen
    • Duesseldorf, Nordrhein-Westfalen, Germany, 40212
      • Recruiting
      • Privatpraxis Dr. Hilton & Partner /ID# 231401
    • Koeln, Nordrhein-Westfalen, Germany, 50996
      • Recruiting
      • Hautzentrum Koeln /ID# 231406

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1: Treatment Group; Participants will receive subdermal injection of HAC20L to the nasolabial folds on Day 1 followed by an optional touch-up treatment on Day 30 if applicable. Participants will then be eligible to receive optional repeat treatment at Month 12 if applicable.	Device: HAC 20L; Subdermal Injections
Other: Cohort 1: Control Group; Participants will not receive treatment for 6 months and then will be offered an optional delayed treatment of HAC 20L after completion of of Month 6 visit with an optional touch-up treatment offered 30 days after delayed treatment.	Other: No-Treatment Control; Participants will not receive treatment for 6 months and then will be offered an optional delayed treatment of HAC 20L after completion of of Month 6 visit with an optional touch-up treatment offered 30 days after delayed treatment.
Experimental: Cohort 2: Treatment Group; Participants will receive subdermal injection of HAC20L to the nasolabial folds on Day 1 followed by an optional touch-up treatment on Day 30 if applicable. Participants will then be eligible to receive optional repeat treatment at Month 12 if applicable.	Device: HAC 20L; Subdermal Injections
Other: Cohort 2: Control Group; Participants will not receive treatment for 6 months and then will be offered an optional delayed treatment of HAC 20L after completion of of Month 6 visit with an optional touch-up treatment offered 30 days after delayed treatment.	Other: No-Treatment Control; Participants will not receive treatment for 6 months and then will be offered an optional delayed treatment of HAC 20L after completion of of Month 6 visit with an optional touch-up treatment offered 30 days after delayed treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	The NLFSS is a 5-point photonumeric scale used by the EI to assess the severity of each NFL where 0 = None and 4 = Extreme. A responder is defined as a participant who shows at least 1-point improvement on the NLFSS from baseline on both sides.	Month 6
Number of Participants with Adverse Events (AEs)	An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this device	Month 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline on the Overall Score of FACE-Q-Appraisal of Lines: Nasolabial Folds Questionnaire	The FACE Q-Appraisal of lines: Nasolabial Folds consists of 5 questions to assess how much the participants has been bothered by various aspects of NLFs in the past week where 1 = not at all and 4 = extremely.	Baseline to Month 6
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)	The GAIS will assess global aesthetic improvement of the NLF area by comparing the frontal and side view photographs taken at baseline where -2 = Much Worse and 2 = Much Improved. A responder is defined as achieving "improved" or "much improved".	Month 6
Percentage of Participants Achieving Responder Status Based on Participant's Assessment of Global Aesthetic Improvement in the NLF Area Using the GAIS	The GAIS will assess global aesthetic improvement of the NLF area by comparing the frontal and side view photographs taken at baseline where -2 = Much Worse and 2 = Much Improved. A responder is defined as achieving "improved" or "much improved".	Month 6

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2023
• Primary Completion (Estimated): August 19, 2026
• Study Completion (Estimated): August 19, 2026

Study Registration Dates

• First Submitted: August 25, 2023
• First Submitted That Met QC Criteria: August 25, 2023
• First Posted (Actual): August 31, 2023

Study Record Updates

• Last Update Posted (Actual): January 23, 2024
• Last Update Submitted That Met QC Criteria: January 22, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Nasolabial Folds; HAC 20L; AGN-8010
• Other Study ID Numbers: M21-833

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
• IPD Sharing Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• IPD Sharing Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No