A Study to Assess Adverse Events and Effectiveness of HAC 22L Injection for Mid-Face Volume in Adult Participants

A Multicenter, Evaluator-blinded, Randomized, Delayed Treatment Control Study of the Safety and Effectiveness of HAC 22L for Improving Midface Volume

Collagen, elastin, and glycosaminoglycans, (eg, hyaluronic acid) are predominant component of the skin and they are key contributor to its characteristics such as strength, elasticity, and plumpness. Chronic reduction in any one of these components as well as a loss of muscle and fat mass contribute to the facial volume loss that characterizes the aging face. HAC 22L is a dermal filler administered via subcutaneous/supraperiosteal injection for volumizing effect. The purpose of the study is to assess adverse events and effectiveness of HAC 22L in adults with facial volume deficit.

HAC 22L is a novel injectable device being developed to improve mid-face volume. Participants are placed in 1 of 2 groups, called treatment arms. There is a 1 in 3 chance that participants will be assigned to the control group. Around 259 adult participants seeking improvement of mid-face volume will be enrolled in the study at approximately 20 sites worldwide.

Participants in the treatment group will receive HAC 22L injection at Day 1. Participants will have the opportunity to receive optional touch-up and will be followed for up to 24 months. An optional repeat treatment will be offered after the follow-up period. Participants in the control group will followed for 6 months (no treatment period). At completion of the control period, participants may exit or opt to receive the study treatment (inclusive of optional touch-up). Participants will then be followed for 6 months. No repeat treatment is offered to the control group.

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 checked by different methods such as medical assessments, questionnaires and instrument's measures.

Study Overview

• Status: Recruiting
• Conditions: Facial Volume Deficit
• Intervention / Treatment: Device: HAC 22L

• Study Type: Interventional
• Enrollment (Estimated): 259
• Phase: Phase 3

Contacts and Locations

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

Study Locations

• Germany
  • Bochum, Germany, 44793
    • Recruiting
    • Hautarztpraxis Dr. Niesmann und Dr. Othlinghaus /ID# 243802
  • Hamburg, Germany, 20146
    • Recruiting
    • Universitaet Hamburg /ID# 251970
  • Kassel, Germany, 34117
    • Recruiting
    • Noahklinik GmbH /ID# 244610
  • Mahlow, Germany, 15831
    • Recruiting
    • Dermatologische Gemeinschaftspraxis Mahlow /ID# 243805
  • Muenchen, Germany, 80333
    • Recruiting
    • Hautok and Hautok-cosmetics /ID# 243800
  • Muenchen, Germany, 80539
    • Recruiting
    • Privatpraxis fuer Dermatologie und Aesthetik /ID# 243803
  • Oberursel, Germany, 61440
    • Recruiting
    • MediCorium Zentrum fuer Dermatologie und Aesthetik /ID# 243799
  • Brandenburg
    • Potsdam, Brandenburg, Germany, 14467
      • Recruiting
      • Haut- und Lasercentrum Potsdam /ID# 243822
  • Hessen
    • Darmstadt, Hessen, Germany, 64283
      • Recruiting
      • Rosenpark Research /ID# 243804
  • Nordrhein-Westfalen
    • Duesseldorf, Nordrhein-Westfalen, Germany, 40212
      • Recruiting
      • Privatpraxis Dr. Hilton & Partner /ID# 243798
    • Koeln, Nordrhein-Westfalen, Germany, 50996
      • Recruiting
      • Hautzentrum Koeln /ID# 244607
• Spain
  • Barcelona, Spain, 08021
    • Recruiting
    • Antiaging Group Barcelona (AGB) /ID# 245446
  • Madrid, Spain, 28006
    • Recruiting
    • Grupo Pedro Jaen /ID# 243347
  • Madrid, Spain, 28001
    • Recruiting
    • Sclinic /Id# 243340
  • Madrid, Spain, 28001
    • Recruiting
    • Instituto de Medicina y Dermatologia Avanzada (IMDA) /ID# 243339
  • Madrid, Spain, 28009
    • Recruiting
    • Instituto de Dermatologia Integral (IDEI) /ID# 245764
  • Malaga
    • Málaga, Malaga, Spain, 29016
      • Recruiting
      • Instituto Medico Miramar /ID# 251640

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Participant in general good health
• Seeking improvement/correction of mid-face volume
• Participant has overall mid-face severity of Moderate (3), Significant (4), or Severe (5) on the 6-point photonumeric MFVDS as assessed by the EI
• Participant capable of giving signed informed consent

Exclusion Criteria:

• Has experienced trauma to the mid-face within 6 months before enrollment or has residual deficiencies, deformities, or scarring.
• Conditions that could interfere with device effectiveness such as current cutaneous or mucosal inflammatory or infectious processes (eg, herpes), rosacea, abscess, an unhealed wound, active acne, or a cancerous or precancerous lesion in the mid-face
• History of keloid scar formation, hypertrophic scarring, and/or post inflammatory hyperpigmentation
• History of pigmentation disorders or current pigmentation disorder in the face
• A history of facial surgeries in the mid-face
• Received fat injection or permanent implants (eg, 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 (eg, calcium hydroxyapatite, poly-L-lactic acid) in the mid-face within 36 months before enrollment, or is planning to be implanted with any of these products at any time during the study
• Temporary soft tissue filler injections in the mid-face within 24 months before enrollment
• Received botulinum toxin treatment to the midface within 6 months before enrollment, or is planning to undergo any such treatment during the study
• Received mesotherapy or cosmetic facial procedures in the mid-face within 6 months before enrollment, or is planning to undergo any such treatment during the study
• Any over-the-counter or prescription oral or topical, anti-wrinkle products for the mid-face within 30 days before enrollment (participants who have been on a regimen of such products for at least 30 days are eligible for the study if they intend to continue their regimen throughout the study)
• Is on a prescribed regimen of anti-coagulation therapy (eg, warfarin, clopidogrel)
• Tattoos, piercings, hair, or scars that would interfere with visualization of the cheek area for the effectiveness assessments
• Pregnant, nursing, or planning a pregnancy

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HAC 22L; Participants will be randomized to receive HAC 22L on Day 1. Participants will have the opportunity to receive optional touch-up and optional repeat treatment of HAC 22L during the follow-up period.	Device: HAC 22L; Subcutaneous and/or Supraperiosteal injection
Other: Control Group; Participants can opt to receive HAC 22L after a control period of 6 months. Participants will have the opportunity to receive an optional touch-up treatment and will be followed for an additional 6 months period.	Device: HAC 22L; Subcutaneous and/or Supraperiosteal injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving "Responder" Status Based on the Evaluating Investigator's (EI) live assessment of Mid-Face Volume Deficit Scale (MFVDS)	A "responder" is a participant with at least 1- grade improvement (reduction) of mid face soft tissue deficit using the MFVDS. MFVDS is a validated 6-point scale (0 = None, 5 = Severe).	Month 6
Number of Participants with Adverse Events	An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a study intervention which does not necessarily have a causal relationship with the treatment. The investigator assesses the relationship of each event to the use of the study intervention.	Up to approximately 25 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline on the Rasch transformed score of the FACE-Q Satisfaction with Cheeks module	In the FACE-Q Satisfaction with Cheeks questionnaire, the responses will be summed and converted to a Rasch transformed score that ranges from 0 to 100.	Month 6
Percentage of Participants Achieving "Responder" Status based on Evaluating Investigator (EIs) assessments of Global Aesthetic Improvement in the treatment area using the Global Aesthetic Improvement Scale (GAIS)	A "responder" is a participant who achieves "Improved" or "Much Improved" on GAIS. GAIS is a 5-point scale used to assess global aesthetic improvement of the cheek area (2=Much Improved, -2=Much Worse).	Month 6
Percentage of Participants Achieving "Responder" Status based on Participant's assessments of Global Aesthetic Improvement in the treatment area using GAIS	A "responder" is a participant who achieves "Improved" or "Much Improved" on GAIS. GAIS is a 5-point scale used to assess global aesthetic improvement of the cheek area (2=Much Improved, -2=Much Worse).	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): June 14, 2023
• Primary Completion (Estimated): September 18, 2026
• Study Completion (Estimated): September 18, 2026

Study Registration Dates

• First Submitted: April 6, 2023
• First Submitted That Met QC Criteria: April 6, 2023
• First Posted (Actual): April 19, 2023

Study Record Updates

• Last Update Posted (Actual): October 2, 2023
• Last Update Submitted That Met QC Criteria: September 28, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Mid-Face Volume; HAC 22L; VOLUMIZE
• Other Study ID Numbers: M21-846

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