Mandibular Hypoplasia Clinical Trial
Official title:
Juvederm Voluma® XC for the Treatment of Hypoplastic Chin
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
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.
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