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

NCT06018987 | Completed Phase 2 DMC

• 1 other identifier: M21-833
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 10

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.

Conditions

Nasolabial Folds

Keywords

HAC 20L; AGN-8010; Nasolabial Folds

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Change from Baseline on the Overall Score of FACE-Q-Appraisal of Lines: Nasolabial Folds Questionnaire

  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)

  Month 6

• Percentage of Participants Achieving Responder Status Based on Participant's Assessment of Global Aesthetic Improvement in the NLF Area Using the GAIS

  Month 6

Study Arms (4)

Cohort 1: Treatment Group

EXPERIMENTAL

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

Cohort 1: Control Group

OTHER

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

Cohort 2: Treatment Group

EXPERIMENTAL

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

Cohort 2: Control Group

OTHER

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

Interventions

No-Treatment Control OTHER

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.

Cohort 1: Control Group; Cohort 2: Control Group

HAC 20L DEVICE

Subdermal Injections

Cohort 1: Treatment Group; Cohort 2: Treatment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (10)

Hautok and Hautok-cosmetics /ID# 254549

Munich, Bavaria, 80333, Germany

Location

Dermatologische Gemeinschaftspraxis Mahlow /ID# 232366

Blankenfelde-Mahlow, Brandenburg, 15831, Germany

Location

MediCorium Zentrum fuer Dermatologie und Aesthetik /ID# 231403

Oberursel, Hesse, 61440, Germany

Location

Hautzentrum Koeln /ID# 231406

Cologne, North Rhine-Westphalia, 50996, Germany

Location

Privatpraxis Dr. Hilton & Partner /ID# 231401

Düsseldorf, North Rhine-Westphalia, 40212, Germany

Location

CRS Clinical Research Services Berlin GmbH /ID# 240390

Berlin, 13627, Germany

Location

Dermatologie am Luegplatz /ID# 233788

Düsseldorf, 40545, Germany

Location

Universitaet Hamburg /ID# 231641

Hamburg, 20146, Germany

Location

Noahklinik GmbH /ID# 231917

Kassel, 34117, Germany

Location

Privatpraxis fuer Dermatologie und Aesthetik /ID# 231402

München, 80539, Germany

Location

Related Links

• Related Info

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2023
• First Posted: August 31, 2023
• Study Start: September 5, 2023
• Primary Completion: February 3, 2025
• Study Completion: February 3, 2025
• Last Updated: February 11, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Locations

DE (10)