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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
61
Subcutaneous and/or Supraperiosteal injection
Hautok and Hautok-cosmetics /ID# 243800
Munich, Bavaria, Germany
Dermatologie Mahlow /ID# 243805
Blankenfelde-Mahlow, Brandenburg, Germany
Haut- und Lasercentrum Potsdam /ID# 243822
Potsdam, Brandenburg, Germany
Rosenpark Research /ID# 243804
Darmstadt, Hesse, Germany
MediCorium Zentrum fuer Dermatologie und Aesthetik /ID# 243799
Oberursel, Hesse, Germany
Hautarztpraxis Dr. Niesmann und Dr. Othlinghaus /ID# 243802
Bochum, North Rhine-Westphalia, Germany
Hautzentrum Koeln /ID# 244607
Cologne, North Rhine-Westphalia, Germany
Privatpraxis Dr. Hilton & Partner /ID# 243798
Düsseldorf, North Rhine-Westphalia, Germany
Universitaet Hamburg /ID# 251970
Hamburg, Germany
Noahklinik GmbH /ID# 244610
Kassel, Germany
...and 7 more locations
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).
Time frame: 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.
Time frame: Up to approximately 25 Months
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.
Time frame: 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).
Time frame: 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).
Time frame: Month 6
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