Juvederm Voluma® XC for the Treatment of Hypoplastic Chin
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Primary outcome will be a change in the facial angle as measured by a blinded facial image analysis technician.
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Primary outcome will be a change in the facial angle as measured by a blinded facial image analysis technician.
时间窗: 12 months
次要结局
- Evaluation of the patient's self image using the satisfaction with lower face and jawline, satisfaction of chin, and appraisal of area under chin modules of the FACE-Q questionnaire.(12 months)
研究者
Kenneth Beer
President
Beer, Kenneth R., M.D., PA