An Open-label, Prospective, Postmarket Study to Assess Altering First Impressions and Self-esteem Following Radiesse® Injections.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Self-esteem
研究概览
简要总结
The purpose of this study is to determine if Radiesse injections to the cheeks result in an altered and improved first impression and self esteem.
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
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Females between 30 and 65 years of age with Fitzpatrick Skin Color Types (I-VI).
- •Have bilateral, fully visible aging defects in the malar area, corresponding to a rating of moderate to severe on the SOBER scale.
- •Willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study.
- •Subjects of childbearing potential must have a negative urine pregnancy test result at Visit 1 and be willing able to use an acceptable method of birth control (e.g., barrier methods used with a spermicidal agent, hormonal methods, IUD, surgical sterilization, abstinence) during the study. Women will not be considered of childbearing potential if one of the following is documented on the medical history:
- •postmenopausal for at least 12 months prior to study drug administration
- •without a uterus and/or both ovaries
- •has had a bilateral tubal ligation for at least 6 months prior to study drug administration.
- •absence of an other physical condition according to the PI's discretion
- •Willingness and ability to provide written photo consent and adherence to photography procedures (i.e., removal of jewelry and makeup).
- •Willingness and ability to provide written informed consent prior to performance of any study related procedure.
排除标准
- •Subjects who are pregnant, nursing, planning to become pregnant, and/or not using a reliable form of birth control.
- •Subjects with a known allergy or sensitivity to any component of the study medications or anesthesia.
- •Subjects who have had prior exposure to any calcium hydroxylapatite, or any other filler, injection for any purpose in the 12 months preceding study enrollment through the duration of the study (excluding study drug).
- •Subjects who have had a prior cosmetic procedure to improve malar eminence deficiency (i.e., rhytidectomy, lower eyelid surgery, cheek implants, CO2/erbium laser resurfacing, Thermage/Thermacool radiofrequency treatment) or who have visible scars that may affect evaluation of response and/or quality of photography.
- •Subjects who have had soft tissue augmentation of the malar area in the previous 6 months.
- •Permanent or semi-permanent dermal fillers in the malar area.
- •Ablative skin resurfacing on the malar area within the previous 6 months or during the study.
- •Retinoid, microdermabrasion, or prescription level glycolic acid treatments to the malar area within 2 weeks prior to study participation or during the study.
- •Active infection in the malar area (e.g., acute acne lesions or ulcers).
- •Marked facial asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring, or thick sebaceous skin.
- •Current history of chronic drug or alcohol abuse.
- •History of autoimmune disease.
- •Concurrent therapy that, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study medication.
- •Subjects who anticipate the need for surgery or overnight hospitalization during the study.
- •Subjects who, in the Investigator's opinion, have a history of poor cooperation, non¬compliance with medical treatment or unreliability.
- •Enrollment in any active study involving the use of investigational devices or drugs.
研究组 & 干预措施
Calcium hydroxylapatite
Subject will be treated at baseline and, if needed, at 2 weeks.
干预措施: Calcium hydroxylapatite (Drug)
结局指标
主要结局
Self-esteem
时间窗: 2 weeks
Self-esteem change will be determined by patient self-evaluation using the Heatherton \& Polivy State Self-Esteem (HPSS). The primary variable will be measured as improvement in self-esteem from baseline self-evaluations. Self-esteem change will be determined by patient self-evaluation using the Heatherton \& Polivy State Self-Esteem (HPSS). The primary variable will be measured as improvement in self-esteem from baseline self-evaluations. A 20-item scale that measures a participant's self-esteem at a given point in time. The 20 items are subdivided into 3 components of self-esteem: (1) performance self-esteem, social self-esteem, and appearance self-esteem. All items are answered using a 5-point scale (1= not at all, 2= a little bit, 3= somewhat, 4= very much, 5= extremely). Scores range from 20-100. Scores closer to 100 indicate a more favorable outcome.
Blinded Evaluations of First Impression
时间窗: After the 1-month post optimal correction visit for 20 subjects (averaged)
Upon completion of the study, 300 blinded evaluators will evaluate one of three binders comprised of a random visit photographs from baseline, optimal cosmetic result, and 1 month post optimal cosmetic result of 20 subjects. The 10-point (1=Not at all to 10=Extremely well) First Impression Scales consisting of 8 criteria. A score of 10 means favorable results and a score of 1 means unfavorable results.
次要结局
- Assessment of Malar Deficiency(1 month)
- Subject First Impression(baseline and 1 month post-OCR (averaged))
- Aesthetic Improvement(1 month)
研究者
Steven H. Dayan
Medical Director
DeNova Research