Juvederm Voluma® XC for the Treatment of Hypoplastic Chin (VolumaChin)
Mandibular Hypoplasia
About this trial
This is an interventional treatment trial for Mandibular Hypoplasia
Eligibility 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
Sites / Locations
- Kenneth R. Beer, M.D., PARecruiting
Arms of the Study
Arm 1
Experimental
Voluma XC
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.