NCT03652844已完成不适用
A Multi-Phase, Prospective, Multi-Center, Single-Blind, Clinical Study to Evaluate the Safety and Efficacy of Allograft Adipose Matrix (AAM) and Diluted AAM for Pre-Jowl and Malar Augmentation to Correct Age Related Volume Deficit in the Face
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 6
- 主要终点
- Volume change for the treated areas using the validated 4 point MEDICIS Mid-Face Volume Scale Assessment (MMVSA) at 24 weeks post-treatment compared to pre-treatment
研究概览
简要总结
The purpose of this study is to evaluate Allograft Adipose Matrix (AAM) in the face of people with age-related volume deficit - fat loss. AAM is a tissue used to correct fat loss. Participation in this study requires injections for placing AAM in the bilateral pre-jowl and malar areas of the face. The research will tell whether AAM is effective in maintaining mid-face fullness and whether the appearance of the skin improves after injection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men or women, 30-70 years of age
- •Has overall mid-facial volume deficit of Grade 3 or 4 on Medicis Midface Volume Scale (MMVS)
- •Willingness and ability to provide written informed consent
- •Has not had AAM injected above the neck
- •Ability to understand and comply with the requirements of the study
- •Negative urine pregnancy test results at the time of study entry (if applicable).
- •Willingness to stay on consistent and current skin care regimen for the duration of the study
- •Willingness to maintain consistent and current diet and exercise for the duration of the study
- •Willingness to forego any cosmetic augmentation procedure for the duration of the study
- •Willingness to be photographed for educational, medical publication and other non-commercial purposes
- •Has BMI ≥18 and ≤30
排除标准
- •A subject with any uncontrolled systemic disease.
- •A subject in whom therapy for a systemic disease is not yet stabilized will not be considered for entry into the study.
- •A subject with a significant history or current evidence of a medical, psychological or other disorder that, in the investigator's opinion, would preclude enrollment into the study.
- •Women that are pregnant, nursing, or planning a pregnancy during the duration of the study
- •A subject that has had AAM injected above the neck
- •A subject unwilling to be photographed for educational, medical publication and other non-commercial purposes
- •A subject with a history of diabetes
- •A subject with known hypersensitivity to any of the components of AAM
- •A subject that has had, or who knowingly will have, dental work +/- 4 weeks prior to, or following AAM injection
- •A subject using any systemic corticosteroid or immunosuppressive medications within 30 days prior to treatment and topical steroids on the face within 14 days prior to treatment and throughout the study
- •A subject that has participated in another research study within 30 days of enrollment in this study
- •A subject that is unwilling to forego any cosmetic augmentation treatment for the duration of the study
- •A subject that has been treated with Botulinum Toxin below the orbital rim within 6 months of study entry.
- •A subject that is unwilling to forego cosmetic facial treatments for the duration of the study
- •A subject that has received Sculptra in the treatment area
- •A subject that has received dermal filler in the treatment area within 2 years prior to randomization
- •A subject that has previously undergone mid-face cosmetic plastic surgery, tissue grafting, or tissue augmentation with silicone, semi-permanent fillers or fat
- •A subject that has previously undergone laser resurfacing, intense pulsed light treatment, chemical peel, or other ablative or non-ablative treatment within 6 months
- •Subject is immunocompromised or immunosuppressed
- •History of keloid formation or hypertrophic scars
- •NSAID or Aspirin, other than a stable low dose aspirin regimen, within 1 week (7 days) prior to treatment
- •Concomitant anticoagulant therapy, antiplatelet therapy, or history of bleeding disorders or connective tissue disorders
- •A subject with recent excessive facial exposure to sunlight or artificial UV light (e.g.: use of tanning beds/booths and/or sunbathing)
- •A subject with a recent history or active presence of any facial skin condition/disease that might interfere with the diagnosis or evaluation of study parameters (i.e. moderate to severe acne vulgaris, atopic dermatitis, psoriasis, rosacea, seborrheic dermatitis, excessive facial hair or coloration)
- •Current participation or participation within 30 days prior to the start of this study in a drug or other investigational research study
- •A subject not deemed to be enrolled at the discretion of the surgeon investigator
结局指标
主要结局
Volume change for the treated areas using the validated 4 point MEDICIS Mid-Face Volume Scale Assessment (MMVSA) at 24 weeks post-treatment compared to pre-treatment
时间窗: 24 weeks
MMVSA measures facial volume deficit, ranging from 1 (fairly full midface) to 4 (substantial loss of fullness in the midface area). Lower values represent a better outcome.
Three-D facial photography (Canfield) with computation of volume changes at 24 weeks compared to pre-treatment.
时间窗: 24 weeks
次要结局
- Duration of effectiveness when the average of the Evaluating Investigators' live assessments of the MMVSA scale will return to, or be worse than, the pre-treatment level over 24 weeks post-treatment.(24 weeks)
- Volume change assessments using the Global Aesthetic Improvement Scale (GAIS) at 24 weeks post-treatment compared to pre-treatment(24 weeks)
研究者
研究点 (6)
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