Clinical trial NCT05818709: A Study to Assess Adverse Events and Effectiveness of HAC 22L Injection for Mid-Face Volume in Adult Participants
Official title: A Multicenter, Evaluator-blinded, Randomized, Delayed Treatment Control Study of the Safety and Effectiveness of HAC 22L for Improving Midface Volume
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Facial Volume Deficit
Keywords: Mid-Face Volume
HAC 22L
VOLUMIZE
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2023-04-19
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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 75 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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants Achieving "Responder" Status Based on the Evaluating Investigator's (EI) live assessment of Mid-Face Volume Deficit Scale (MFVDS)
timeFrame: Month 6
measure: Number of Participants with Adverse Events
timeFrame: Up to approximately 25 Months
Secondary outcomes:
measure: Change from baseline on the Rasch transformed score of the FACE-Q Satisfaction with Cheeks module
timeFrame: Month 6
measure: 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)
timeFrame: Month 6
measure: Percentage of Participants Achieving "Responder" Status based on Participant's assessments of Global Aesthetic Improvement in the treatment area using GAIS
timeFrame: Month 6
Other outcomes:
Locations:
city: Blankenfelde-Mahlow
country: Germany
facility: Dermatologische Gemeinschaftspraxis Mahlow /ID# 243805
state: Brandenburg
city: Potsdam
country: Germany
facility: Haut- und Lasercentrum Potsdam /ID# 243822
state: Brandenburg
city: Darmstadt
country: Germany
facility: Rosenpark Research /ID# 243804
state: Hessen
city: Duesseldorf
country: Germany
facility: Privatpraxis Dr. Hilton & Partner /ID# 243798
state: Nordrhein-Westfalen
city: Koeln
country: Germany
facility: Hautzentrum Koeln /ID# 244607
state: Nordrhein-Westfalen
city: Bochum
country: Germany
facility: Hautarztpraxis Dr. Niesmann und Dr. Othlinghaus /ID# 243802
city: Hamburg
country: Germany
facility: Universitaet Hamburg /ID# 251970
city: Kassel
country: Germany
facility: Noahklinik GmbH /ID# 244610
city: Muenchen
country: Germany
facility: Hautok and Hautok-cosmetics /ID# 243800
city: Muenchen
country: Germany
facility: Privatpraxis fuer Dermatologie und Aesthetik /ID# 243803
city: Oberursel
country: Germany
facility: MediCorium Zentrum fuer Dermatologie und Aesthetik /ID# 243799
city: Málaga
country: Spain
facility: Instituto Medico Miramar /ID# 251640
state: Malaga
city: Barcelona
country: Spain
facility: Antiaging Group Barcelona (AGB) /ID# 245446
city: Madrid
country: Spain
facility: Instituto de Medicina y Dermatologia Avanzada (IMDA) /ID# 243339
city: Madrid
country: Spain
facility: Sclinic /Id# 243340
city: Madrid
country: Spain
facility: Grupo Pedro Jaen /ID# 243347
city: Madrid
country: Spain
facility: Instituto de Dermatologia Integral (IDEI) /ID# 245764
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: