The objectives of this study are to evaluate: • the safety of VYC-25L injectable gel in subjects seeking to increase facial volume in the chin and jaw area • the performance of VYC-25L injectable gel in restoring and creating facial volume in the…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
cosmetische behandeling
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
The shape and projection of the chin contribute to the proportional balance of
the face. A chin lacking projection is commonly labeled a *weak chin* whereas
prominent chins are labeled *strong chins* and imply strength of personality
(Naini, 2011). Several studies have suggested that faces with average
proportions are viewed as the most attractive and that juvenile features
including a small chin are interpreted as attractive in females while a strong
chin and jaw are interpreted as attractive in males (Jones and Hall, 1993;
Schact, 2005). The appearance of the chin is a determinant of perceived
attractiveness and can influence an individual*s psychosocial well-being
(Naini et al, 2012).
A retrusive chin can be the result of changes in growth of the lower third of
the face during maturation, trauma, or facial aging, the latter of which may
exacerbate the deformities or asymmetries caused by the former two. The shape
of the mandible affects the mouth, chin, and neck. As an individual ages, the
reduction in skeletal support of this region makes soft tissue atrophy
prominent, exaggerating jowls, decreasing chin protrusion, and making the
jawline look weak (Romo and Lanson, 2008). Chin deformities are among the most
common bony abnormalities of the face, the most common of which is horizontal
microgenia characterized by the presence of normal vertical height with a
retruded bony chin
(Guyuron et al, 1995).
As the mandible and chin are the framework of the lower face, augmentation
methods to treat age-related chin retrusion and contour changes of the chin
area or to treat microgenia have been explored for decades. Where the approach
in correcting chin retrusion is to add volume, treatment methods have included
chin implants, genioplasty, and injection of silicone and semi-permanent
fillers, such as polymethylmethacrylate microspheres, and calcium
hydroxyapatite. However, all of these treatment methods have drawbacks. For
example, chin implants and genioplasty involve painful surgery that may not
result in correction of chin retrusion and aesthetic blending of the area. This
approach may exacerbate bone resorption and infection, resulting in the need
for implant removal (Frodel, 2005; Rubin and Yaremchuk, 1997; Yaremchuk,
2003). Injection of semi-permanent fillers have trade-offs between volumizing
capacity and adverse events. Temporary dermal fillers could offer a better
alternative. VYC-25L is a temporary HA dermal filler that is a structural gel
manufactured specifically to provide a safe, minimally invasive method to
restore and create facial volume. VYC-25L is similar to JUVÉDERM ® VOLUMA* with
Lidocaine, with the primary difference between the 2 products being the
concentration of HA, which is 20 mg/mL in JUVÉDERM ® VOLUMA* with Lidocaine and
25 mg/mL in VYC-25L. The higher concentration of HA in VYC-25L is expected to
provide improved volumizing and lift properties. VYC-25L is indicated for
injection into the subcutaneous and/or supraperiosteal space, and because it is
moldable after injection, VYC-25L permits sculpting, contouring, and shaping
across the injected areas. As the chin and jaw are high mobility areas, they
represent an excellent target for testing the volumizing and lift capabilities
of VYC-25L as well as its durability. The current study will investigate the
safety and performance of VYC-25L in subjects seeking to increase facial volume
in the chin and jaw area.
• Naini FB, Donaldson AN, McDonald F, Cobourne MT. Assessing the influence of
chin prominence on perceived attractiveness in the orthognathic patient,
clinician, and layperson. Int J Oral Maxillofac Surg. 2012;41(7):839-846.
• Jones D, Hall K. Criteria of facial attractiveness in five populations. Hum
Nat. 1993;4(3):271-296.
• Schact R. Female and Male Perceptions of Attractiveness: What is Attractive
and Why? Nebraska Anthropologist. 2005;8:63-69. Yaremchuk MJ. Improving
aesthetic outcomes after alloplastic chin augmentation. Plast Reconstr Surg.
2003;112:1422-1432.
• Romo R, Lanson GB. Chin Augmentation. Fac Plast Surg Clin North Amer.
2008;16(1):69-77.
• Guyuron B, Michelo BJ, Willis L. Practical classification of chin
deformities. Aesthet Plast Surg. 1995:19(3):257-264.
• Frodel JL. Evaluation and treatment of deformities of the chin. Fac Plast
Surg Clin North Amer. 2005;13(1):73-85.
• Rubin JP and Yaremchuk MJ. Complications and toxicities of implantable
biomaterials used in facial reconstructive and aesthetic surgery: a
comprehensive review of the literature. Plast Reconstr Surg.
1997;100:1336-1353.
•Yaremchuk MJ. Improving aesthetic outcomes after alloplastic chin
augmentation. Plast Reconstr Surg. 2003;112:1422-1432.
Study objective
The objectives of this study are to evaluate:
• the safety of VYC-25L injectable gel in subjects seeking to increase facial
volume in the chin and jaw area
• the performance of VYC-25L injectable gel in restoring and creating facial
volume in the chin and jaw area and in sculpting, shaping, and contouring
across the pogonion, mentum, pre-jowl sulci (left and right), and sublabial
(mental) crease
Study design
This is a prospective, multicenter, single-blind, randomized, controlled
study. Up to 10 investigational sites will enroll and follow subjects who meet
the study criteria.
This study is designed to evaluate the safety and performance of VYC-25L
hyaluronic acid (HA) injectable gel for the restoration and creation of facial
volume in subjects seeking to increase projection of the chin and/or jaw. At
screening after informed consent has been given, the investigator will document
the subject*s demographics, height, weight, vital signs, Fitzpatrick skin
phototype, and history of sun exposure, smoking, and medical, surgical, dental,
and cosmetic procedures. Female subjects of childbearing potential will
undergo urine pregnancy tests. All subjects will undergo 3-dimensional (3D)
facial digital imaging that will capture frontal and profile views. The
investigator will use these images and facial measurement software to measure
and document the angle of chin retrusion, as determined by the angle formed by
points on the glabella, subnasale, and pogonion (G-Sn-Pog) to determine
eligibility for the study. Eligible subjects will complete the Satisfaction
with Chin, Satisfaction with Lower Face and Jawline, and Psychological
Well-Being modules of the FACE-Q Patient Reported Outcomes questionnaire. The
study will target to enroll 20 subjects of Asian descent (based on the
subject*s identification of descent).
Subjects will be randomized in a 3:1 ratio either to have treatment with
VYC-25L at the outset of the study (treatment group) or to have treatment
delayed by 3 months (control group). Subjects randomized to the treatment
group will undergo treatment on the same day. Subjects randomized to the
control group will attend visits at months 1 and 3 in the control period
(no-treatment period) and undergo 3D facial digital imaging at these visits for
objective calculation of the angle of chin retrusion by an image analysis
technician who will remain blinded to the subjects* randomized assignments.
After the completion of the control period, subjects randomized to the control
group will receive treatment to increase chin projection and follow the same
schedule of visits (except month 24) and procedures in the treatment period as
described below for subjects randomized to have treatment at the outset of the
study.
On the initial treatment day using needles (27 gauge x 13 mm) supplied with the
kit, the investigator will inject VYC-25L subcutaneously and/or
supraperiosteally to increase chin projection. On the initial treatment day,
before treatment, the subject will undergo 3D facial digital imaging that will
capture frontal and profile views. Pretreatment anesthesia will be applied as
necessary. Following treatment, the investigator will evaluate treatment
characteristics, including injection ease and moldability. Subjects will
assess the procedural pain on an 11-point scale, and 3 days after treatment,
subjects will complete the Recovery Early Life Impact and Recovery Early
Symptoms modules of the FACE-Q questionnaire. The subject will complete a
daily safety electronic diary (e-diary) for 30 days after the treatment
session. Safety visits will occur 3 and 14 days after treatment at which time
the investigator will evaluate the treatment areas for localized reaction and
will review the safety e-diary with the subject and discuss reported symptoms.
The subject may undergo a top-up treatment 30 days after initial treatment (ie,
month 1 INITIAL ) if the investigator assesses that optimal (full) correction
of chin retrusion and/or aesthetic contouring was not achieved. Before
treatment on the top-up treatment day, the subject will undergo 3D facial
digital imaging that will capture frontal and profile views. The subject will
complete a new safety e-diary for 30 days after top-up treatment and will
return 3 and 14 days following treatment. At that time, the investigator will
evaluate the treatment areas for localized reaction and will review the safety
e-diary with the subject and discuss reported symptoms.
Routine follow-up visits for safety and effectiveness will occur at 1, 3, 6, 9,
12, 15, 18, and 21 months after the last treatment for the control group and at
1, 3, 6, 9, 12, 15, 18, 21, and 24 months after the last treatment for the
treatment group. At each visit the investigator and subject will assess global
aesthetic improvement in the chin and jaw area using the Global Aesthetic
Improvement Scale (GAIS), and subjects will undergo 3D facial digital imaging
(frontal and profile views) for objective calculation of the angle of chin
retrusion by the blinded image-analysis technician. At months 1, 3, 6, 12, and
18 for the control group and months 1, 3, 6, 12, 18, and 24 for the treatment
group, subjects will complete the Satisfaction with Chin, Satisfaction with
Lower Face and Jawline, and Psychological Well-Being modules of the FACE-Q
questionnaire.
At a scheduled visit between months 18 and 24 for the treatment group and
between months 18 and 21 for the control group, an optional repeat treatment
with VYC-25L may be administered if warranted in the investigator*s opinion and
desired by the subject. Reasons for not opting for repeat treatment will be
collected. On the repeat treatment day before treatment, the subject will
undergo 3D facial digital imaging. Subjects will complete a daily safety
e-diary for 30 days after repeat treatment and return for a follow-up visit at
1 month after repeat treatment. At the month 1 visit after repeat treatment,
the investigator and subject will assess global aesthetic improvement in the
chin and jaw area using the GAIS, subjects will undergo 3D facial digital
imaging for objective calculation of the angle of chin retrusion by the blinded
image-analysis technician, and subjects will complete the Satisfaction with
Chin, Satisfaction with Lower Face and Jawline, and Psychological Well-Being
modules of the FACE-Q questionnaire.
Intervention
One group will receive immediate treatment with VYC-25L. In the other group,
the treatment with VYC-25L is delayed by 3 months.
Study burden and risks
Potential risks include redness, swelling, or rashes which can accompanied by
itching, pain and pressure just after the treatment. These reactions can last
about a week. To reduce these risks, participants are recommended to avoid
strenuous exercise, prolonged exposure to the sun, Ultra Violet rays, and
temperatures below 0°C, and must refrain from using a sauna or steam room for 2
weeks. Furthermore, the following adverse reactions may occur: bruises, lumps
at the injection site, coloration or discoloration of the injection site. Rare
cases of abscesses, granuloma, and immediate or delayed hypersensitivity after
HA or lidocaine injections have been reported.
Marlow International, Parkway Marlow -
Buckinghamshire SL7 1 YL
GB
Marlow International, Parkway Marlow -
Buckinghamshire SL7 1 YL
GB
Listed location countries
Age
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
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 conduction, severely impaired hepatic function, or severe renal dysfunction
19.Is on an ongoing regimen of anti-coagulation therapy (eg, warfarin)
20.Is on an ongoing regimen of medications (aspirin, ibuprofen) or other substances known to increase coagulation time (eg, herbal supplements with garlic or gingko biloba) within 10 days of undergoing study device injection (study device injection may be delayed as necessary to accommodate this 10-day washout period)
21.Has received any investigational product within 90 days prior to study enrollment or is planning to participate in another investigation during the course of this study
22.Has begun using any over-the-counter or prescription, oral or topical, anti-wrinkle products below the subnasale within 30 days before enrollment or is planning to begin using such products during the study (subjects 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)
23.Females who are pregnant, nursing, or planning a pregnancy
24. Be a female of childbearing potential not using a reliable mean of contraception
25.Is an employee (or a relative of an employee) of the investigator, Allergan, or representative of Allergan
26.Has a condition or is in a situation which in the investigator*s opinion may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject*s participation in the study
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL50549.075.14 |