Mid Face Volume Deficit
Conditions
Keywords
Mid Face Volume Deficit, HArmonyCa Lidocaine, Restylane® Perlane® Lidocaine, Mid-Face China
Brief summary
The cumulative effect of aging and environmental exposures (ie, ultraviolet, infrared, and visible light radiation and pollution) leads to wrinkles, discoloration, laxity, and roughness of sun exposed skin. The rapid restoration of soft tissue augmentation is commonly achieved by the use of dermal fillers. HArmonyCa Lidocaine injectable gel is a dermal filler intended for facial soft tissue augmentation. The purpose of this study is to assess adverse events and effectiveness of HArmonyCa Lidocaine injectable gel compared to Restylane® Perlane® Lidocaine (Perlane) in adults seeking restoration and/or correction of moderate to severe mid-face volume deficit. HArmonyCa Lidocaine Injectable Gel is an investigational device being developed for soft tissue augmentation in the mid face. 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 receive active comparator, Perlane. Around 252 adult participants seeking restoration and/or creation of mid-face volume will be enrolled in the study at approximately 9 sites in China. Participants will receive HArmonyCa Lidocaine injectable gel or Perlane at Day 1 with an option touch-up treatment on Day 31. Participants will be followed for up to 12 Months after last treatment. 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. The effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires.
Interventions
Subdermal or Deep Dermal or Supraperiosteal Injection
DEVICERestylane® Perlane® Lidocaine
Subcutaneous to Supraperiosteal Implantation Injection
Sponsors
AbbVie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Has moderate (3), significant (4), or severe (5) mid-face volume deficit on the Mid-face Volume Deficit Scale (MFVDS) 5-point photonumeric scale based on evaluating investigator (EI) live assessment at randomization visit. * Mid-face areas are amenable to achieving at least a 1-point improvement in MFVDS score with the allowed injection volume in the treating investigator's (TI) judgment. * Must be in good health as determined by medical history, physical examination, vital signs, and investigator's judgment, including no known active pandemic infection.
Exclusion criteria
* Excessive skin laxity in the mid-face area in the opinion of the TI. * Significant skin pigmentation disorders or discoloration in the mid-face area that would interfere with the visual assessment of the mid-face area. * Semi-permanent soft tissue filler treatment (e.g., CaHA, poly-L-lactic acid) in the face within 36 months before randomization.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving Responder Status Based on the Evaluating Investigator's (EI) Live Assessment of Mid-Face Volume Deficit Scale (MFVDS) | Month 6 | A responder is a participant with at least 1-point improvement (reduction) of mid face volume deficit using the MFVDS. MFVDS is a validated 5-point scale (1 = None/Minimal to 5 = Severe). |
| Number of Participants with Adverse Events (AEs) | Up to Approximately Month 14 | An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a medical device which does not necessarily have a causal relationship with this treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving Responder Status Based on EI's Assessments of Global Aesthetic Improvement in the Treatment Area Using the Global Aesthetic Improvement Scale (GAIS) | Month 6 | 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 treatment area (2 = Much Improved, -2 = Much Worse). |
| Percentage of Participants Achieving Responder Status Based on Participant's Assessments of Global Aesthetic Improvement in the Treatment Area Using GAIS | Month 6 | 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 treatment area (2 = Much Improved to -2 = Much Worse). |
| Change from Baseline on the Overall Score of FACE-Q Satisfaction with Cheeks | Month 6 | The FACE-Q Satisfaction with Cheeks questionnaire is a 5-point survey where 1 = Very Dissatisfied and 4 = Very Satisfied. |
Countries
China
Outcome results
None listed