cosmetische behandeling facial volume loss
Conditions
Interventions
One group will receive immediate treatment with VYC-25L. In the other group,
the treatment with VYC-25L is delayed by 3 months.
Sponsors
Allergan
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. 18 years of age or older and in good general health 2. Has chin retrusion (G-Sn-Pog angle of 145° to 165°) based on calculations of facial angle derived from digital images obtained using Canfield imaging equipment and software 3. Investigator considers the subject*s chin/jaw retrusion to be amenable to correction with a treatment goal consistent with increasing chin projection horizontally (in the profile view) 4. Ability to follow study instructions and likely to complete all required visits 5. Written informed consent has been obtained
Exclusion criteria
Exclusion criteria: 1. Has clinically significant malocclusion and/or macrogenia (ie, Class I [macrogenia: excess in the vertical or horizontal dimension or excess in both dimensions], Class III [combined macrogenia and microgenia: excess in one dimension with deficiency in the other], or Class VI [pseudomacrogenia: excess soft tissue over a normal skeleton]) in the investigator*s judgment 2. Has ever received permanent facial implants (eg, polymethylmethacrylate, silicone, polytetrafluoroethylene) anywhere in the face or neck, or is planning to be implanted with any of these products during the study 3. Has tattoos, piercings, facial hair (ie, beard, mustache), or scars below and including the subnasale that would interfere with visual assessment of the chin, jowls, or jawline 4. Has dentures or any device covering all or part of the palate or is planning to undergo any dental procedure (other than prophylaxis and dental fillings) during the study 5. Has undergone semipermanent dermal filler treatment (eg, calcium hydroxyapatite, poly-L-lactic acid) in the chin or jaw area within 36 months before enrollment or is planning to undergo such treatment during the study 6.Has undergone dermal filler injections or fat injections, or has undergone any surgery in the chin or jaw area (including marionette lines, pre-jowl sulci, mandibular body, or masseter muscles) within 24 months before enrollment or is planning to undergo any of these procedures during the study 7. Has undergone dermal filler injections in the glabellar area or nose within 12 months before enrollment or is planning to undergo such treatment within the first 3 months after study treatment 8. Has undergone mesotherapy or cosmetic resurfacing (laser, photomodulation, intense pulsed light, radio frequency, dermabrasion, moderate or greater depth chemical peel, or other ablative procedures) anywhere in the face or neck or botulinum toxin injections below the subnasale (including injections to the masseter muscles) within 6 months before enrollment or is planning to undergo any of these procedures during the study 9. Has experienced trauma to the chin and jaw area within 6 months before enrollment or has residual deficiencies, deformities, or scarring 10.Has, in the opinion of the investigator, significant skin laxity in the chin, jaw, or neck 11.Has a tendency to develop hypertrophic scarring 12. Has been previously diagnosed with streptococcal disease (eg, recurrent sore throat, acute rheumatic fever) 13.Has a history of anaphylaxis or allergy to lidocaine (or any amide-based anesthetics), hyaluronic acid products, or Streptococcal protein, or is planning to undergo desensitization therapy during the term of the study 14.Has porphyria or untreated epilepsy 15.Has active autoimmune disease 16.Has current cutaneous or mucosal inflammatory or infectious processes (eg, acne, herpes, gum disease), abscess, an unhealed wound, or a cancerous or pre-cancerous lesion below the subnasale (Study device injection may be delayed for subjects with a history of recurrent oral herpes lesions who take prophylactic doses of antiviral/herpes medication for at least 2 days before study treatment administration.) 17.Is on a concurrent regimen of lidocaine or structurally-related local anesthetics (eg, bupivacaine); is on a concurrent regimen of drugs that reduce or inhibit hepatic metabolism (eg, cimetidine, beta blockers) 18.Has impaired cardiac c
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary effectiveness measure is the subject*s G-Sn-Pog angle, based on analysis of angular measurements by a blinded image-analysis technician from digital images of subject*s facial profile. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary effectiveness measures include investigator and subject assessments of global aesthetic improvement in the chin and jaw area using the 5-point GAIS. Other effectiveness measures include 1) subject responses on the Satisfaction with Chin module of the FACE-Q questionnaire, 2) subject responses on the Satisfaction with Lower Face and Jawline module of the FACE-Q questionnaire, 3) subject responses on the Psychological Well-Being module of the FACE-Q questionnaire, 4) 3D volumetric data from analysis of digital images of subject*s facial profile, and 5) distance measurement of chin projection from analysis of digital images of subject*s facial profile. Safety: Safety measures include subject assessment of procedural pain on an 11-point scale and subject responses to the Recovery Early Life Impact and Recovery Early Symptoms modules of the FACE-Q questionnaire. Additional safety measures include the presence, severity, and duration of injection site responses (ISRs), which will be recorded by the subject in the safety e-diaries for 30 days after treatment (initial, top-up, repeat) and any adverse events from investigator observation and inquiry of adverse events at scheduled follow-up visits. | — |
Countries
Netherlands
Outcome results
None listed