West Palm Beach,
Florida
33401
Purpose:
This is a single center study of the safety and efficacy of Juvedérm Voluma for the
treatment of hypognathism.
Each qualified subject will undergo treatment with Juvedérm Voluma in the anterior and
lateral chin for volume correction. Prior to treatment, the principal investigator will
evaluate the severity of chin recession using a 90 degree image and a goniometer to measure
the angle from the glabella to the chin. Subjects will be eligible for injection if the
angle measures between 145 - 160 degrees. Facial digital photography will be captured prior
to treatment and at each subsequent visit. The subject will complete a safety and injection
site response (ISR) diary beginning on the evening of treatment.
The subject will return at Day 3 and Day 14 after initial treatment, at which time the
subject will undergo photography and the investigator will rate treatment improvement
(GAIS). An independent image analysis technician will assess the degree of correction. The
investigator will evaluate the treatment area for any adverse events (AEs).
The subject will return 30 days after initial treatment, and the principal investigator will
determine if a touch-up treatment is warranted. If deemed necessary, a touch-up treatment
may be administered. Facial digital photography will be captured prior to treatment and
following treatment. The subject will return 3 days after the touch-up to undergo digital
photography and for the principal investigator to assess safety/improvement.
After initial or touch-up treatment, whichever is last, routine follow-up visits for safety
and effectiveness will occur at 1 (30 days), 2, 4, 6, 9 (telephone call only) and 12
months. At all follow-up visits, facial digital photography will be captured and the
investigator will rate treatment improvement (GAIS).. At screening and at Months 1, 2, 4, 6
and month 12 subjects will complete the satisfaction of face overall module of the FACE-Q
questionnaire.
The goal of this study will be to assess the feasibility of Voluma XC for the treatment of
hypoplastic chins
Study summary:
Primary Objective: To evaluate efficacy of Voluma XC for the treatment of hypoplastic chins.
Secondary Objective: To evaluate patient satisfaction and improvement of GAIS following
treatment with Voluma for hypoplastic chins.
The expected outcome following deep (dermal and/or supra periosteal) injection of Voluma
when used to treat hypognathism is significant improvement in the facial angle of the chin.
Significant improvement defined as the mean change in the facial angle of the face measured
by the blinded digital image analysis technician. A secondary effectiveness measure will be
patient and treating investigator measure of improvement using the FACE-Q questionnaires as
well as the mean change in the GAIS score.
The study will span a total of approximately 15 months: an estimated 2 months for
recruitment and 12 months for follow-up. Each subject's participation will encompass a
screening/baseline visit, Day 3 and a Day 14 visit with a possible 1 month touch up (if
touch up occurs then a day 3 and a day 14 and a month 1 will occur following the touch up
then followed by study visits at 2, 4, 6, month and a 9 month telephone safety visit and a
12 month clinic visit (end of study).
JUVÉDERM® Voluma XC Injectable Gel No control treatment will be used. The primary
effectiveness endpoint will be one month after optimal correction has been attained
according to the investigator.
The image analysis technician performing the evaluation will be blinded as to the amount of
product injected. All digital photos will be analyzed in a batched, randomized format
(including the pre-treatment photos) in order to blind the technician.
Retreatment Criteria (if applicable) Study subjects will return for possible touch up 1
month following initial injection. At this time, the investigator and the subject will
evaluate the outcome of the initial treatment. In the event that both the subject and the
investigator concur that additional treatment is indicated because of a suboptimal aesthetic
correction, a repeat injection of Voluma XC will be performed. If a repeat treatment does
take place then the subject will then be followed at Day 3 and Day 14 and Day 30. In the
event that the subject does not want retreatment the subject will remain in the study and
followed through the course of the trial.
The subject will undergo treatment and return for follow-up visits throughout the study
period. At each visit, the Principal Investigator or designee will record AEs and
concomitant medications, therapies, and treatments. All reported AEs will be documented. The
procedures to be performed at each visit are described below.
Injections of Voluma will be accomplished using a serial puncture and fanning technique with
the needle inserted to the periosteal plane as well as in the subcutaneous plane. The
treatment area will include the medial and lateral chin as defined: lateral chin landmark is
the depressor anguli oris.
Photography will be mandatory to participate in this clinical trial. Subjects will consent
to allow Kenneth R. Beer, M.D., PA permission to use photographs for FDA advisory panel
meetings, scientific journals and conferences, advertising, publicity, and promotional
purposes as one option. Additional options will be given to the subject to allow Kenneth R.
Beer, M.D., PA to only use photographs for FDA advisory panel meetings and scientific
journals and conference, but does NOT have permission to use the photographs for
advertising, publicity, or promotional purposes as option 2. The third and final option
allows the subject to have photographs taken, but subject does NOT give permission to use
photographs for FDA advisory panel meetings, scientific journals and conferences,
advertising, publicity, and promotional purposes.
The photographs will be taken with 3D photography system and will be analyzed by a third
party which is hired by the sponsor. Full confidentiality cannot be maintained due to the
entire face will be photographed. Confidentiality will try to be maintained by only using
subject identifiers. If at a later date the subject does not want photos used for other
purposes that were consented to the subject at any time during the course of the study will
be allowed to change and update the photograph consent. If subject withdraws all photo
consent the subject will be discontinued from the study since photographs are mandatory to
participate in this clinical study.
The Principal Investigator will ensure that each subject meets the eligibility criteria. The
Principal Investigator will capture a 90 degree angle photo and using a goniometer to
manually measure the angle between the glabella and the mentalis and subjects with angles
between 145-160° will be included in the study. The Principal Investigator or designee will
record reasons for those subjects who withdraw consent prior to randomization or who do not
meet the inclusion/exclusion criteria.
The Principal Investigator or designee will collect and record the subject's demographic
information, medical and surgical history, cosmetic procedures history, and Fitzpatrick skin
phototype.
Initial Treatment Visit (Day 0) If Screening and Day 0 visit are on the same day, all
procedures performed at Screening will be performed at Screening will be performed once,
prior to treatment administration.
Prior to treatment, vital signs (blood pressure, heart rate, respiration rate, and
temperature only) will be measured. Study staff will attain subject demographics, medical,
cosmetic, and dental history. A negative UPT test will be confirmed prior to randomization.
Photos will be taken with the Canfield Vectra 3D system. Subjects will be asked to
complete the FACE-Q questionnaire licensed by Memorial Sloan Kettering (3). Concomitant
medications will be captured. A subject diary will be given to each subject to complete for
30 days. A Investigator assessment of chin function will be completed prior to injections.
Day 3 (+/- 2days) Subject will return to clinic for Day 3 follow up. Subject will be
photographed with the Canfield Vectra 3D system and the investigator will rate the
improvement using the GAIS score and Investigator Assessment of chin function.
Day 14 (+/-3 days) Subject will return to clinic for Day 14 follow up. Subject will be
photographed with the Canfield Vectra 3D system and the investigator will rate the
improvement using the GAIS score and Investigator Assessment of chin function.
Day 30 retreatment visit or Month 1 visit (+/-7days) Subject will be assessed by
investigator to determine if retreatment is needed. If no retreatment occurs then visit
will become the one month visit.
Month 1 Visit Subject will be photographed with the Canfield Vectra 3D system, investigator
GAIS score and FACE Q questionnaire completed, adverse events captured, collection of diary,
and concurrent procedures documented.
Retreatment Visit If retreatment is needed the visit schedule will be as follows from the
date of retreatment day 3 (+/- 2 days), day 14 (+/- 3 days) and then day 30 (+/- 7 days).
Subject and investigator will then complete Month 1 visit requirements as documented above.
(Same procedures will be followed from initial injection) Month 2 (+/- 14 days) Subject will
be photographed with the Canfield Vectra 3D system, investigator GAIS score, and
Investigator Assessment of chin function, Face Q questionnaire, adverse events and
concurrent procedures captured.
Month 4 (+/- 14 days) Subject will be photographed with the Canfield Vectra 3D system,
investigator GAIS score, and Investigator Assessment of chin function, Face Q questionnaire,
adverse events and concurrent procedures captured.
Month 6(+/- 14 days) Subject will be photographed with the Canfield Vectra 3D system,
investigator GAIS score, and Investigator Assessment of chin function, Face Q questionnaire,
adverse events and concurrent procedures captured.
Month 9 (+/- 14 days) telephone safety call Subject will be called to review any new
concomitant medications or any new adverse events since month 6 visit.
10 Month 12 (+/-14 days) End of Study Visit Subject will be photographed with the Canfield
Vectra 3D system, investigator GAIS score, and Investigator Assessment of chin function,
Face Q questionnaire, adverse events and concurrent procedures captured. End of Study page
completed Instructions for the Subjects
- Following injection with Voluma, application of ice for 10 minutes per hour while awake
may help to reduce swelling and this may be used for a period of 3-5 days.
- Discomfort may be treated with acetaminophen.
- Gentle massage may also be used to minimize lumps and bumps which are more common
during the first 7 days following treatment.
Criteria:
Inclusion Criteria:
Male or female, 22 years and above Has moderate to severe chin hypognathism Moderate to
severe hypognathism 145-160 degrees as measured with goniometer by principal investigator
at screening visit. All other measurements will be performed by a blinded Canfield facial
image analysis technician. Written informed consent has been obtained Written
Authorization for Use and Release of Health and Research Study Information has been
obtained Written documentation has been obtained in accordance with the relevant country
and local privacy requirements, where applicable. Ability to follow study instructions and
likely to complete all required visits If the subject is a female of childbearing
potential (sexually active and not sterile, surgically sterilized, or postmenopausal with
no menses for at least 1 year), have a urine pregnancy test evaluated as negative at
randomization, have used contraception for at least 30 days prior to enrollment, and agree
to use a reliable method of contraception for the duration of the study. Subject agrees
to abstain from any treatment to the lower 1/3 of the face including botulinum toxins,
hyaluronic acid fillers, cosmetic surgery, laser/light therapy, chemical peels, etc.
Exclusion Criteria:
Uncontrolled systemic disease. Severe cardiovascular disease. Known allergy or sensitivity
to the study medication(s) or its components Females who are pregnant, nursing, or
planning a pregnancy. Pregnancies that occur will be followed by the sponsor until
delivery or termination. Current enrollment in an investigational drug or device study or
participation in such a study within 30 days of entry into this study and for the duration
of the study. Previous treatment to the glabella, philtrum or chin with hyaluronic acid
fillers or semi-permanent filler (i.e. Radiesse) in the past 12 months and for the
duration of the study Any use of permanent filler materials such as Artefill or silicone
in the face. Subjects planning a facial cosmetic procedure during the study period or
with prior cosmetic procedures (i.e. surgery) in the treatment area or visible scars that
may affect the evaluation.
Subjects will need to be on the same facial product regimen for 90 days and no topical
anti-wrinkle products on the chin. Had received (or was planning to receive)
anti-coagulation medication(e.g., warfarin) from 10 days pre to 3 days post-injection.
Planned rhinoplasty Any subjects with volume deficit due to trauma, abnormalities in
adipose tissue related to immune-mediated diseases such as generalized lipodystrophy
(e.g., juvenile dermatomyositis), partial lipodystrophy (e.g., Barraquer-Simons syndrome),
inherited disese, or HIV-related disease. Infection or dermatoses at the injection site.
Evidence of recent alcohol or drug abuse. Medical and/or psychiatric problems that is
severe enough to interfere with the study results.
Known bleeding disorder or is receiving medication that will likely increase the risk of
bleeding as the result of injection. Has facial hair that would interfere with evaluation
and treatment of the chin area Has a tendency to develop hypertrophic scarring Has a
history of anaphylaxis or allergy to lidocaine (or any amide-based anesthestics), HA
products, or Streptococcal protein.
Has porphyria Has an active inflammation, infection, cancerous or precancerous lesion,
or unhealed wound in the lower face/jawline or chin area.
Subject 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