Open-Label Proof-of-Concept Study of CelluJuve® for the Treatment of Moderate to Severe Nasolabial Folds
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Wrinkle Severity Rating Scale (WSRS)
研究概览
简要总结
Single-center, open-label proof of concept study assessing the safety and effectiveness of CelluJuve® for the treatment of moderate to severe NLFs
详细描述
All subjects will receive injections of CelluJuve® into both NLFs at Visit 1 (Baseline) and will receive touch-up treatments (if necessary) at Week 4 (Visit 2).
Subjects will then be followed for 24 months after their last treatment (Visit 1 or Visit 2). Follow-up visits will occur every 3 months to collect safety and effectiveness data continuing through Month 24. The study will terminate after completion of the Month 24 visit.
At each study visit, safety will be assessed through adverse event reporting and injection sites will be assessed for the common treatment responses (CTRs) that typically occur following the injection of a dermal filler (i.e., erythema, pain, tenderness, firmness, swelling, lumps/bumps, bruising, itching, and discoloration).
Blood sampling will be performed for safety laboratory testing and immunogenicity testing. Photography of the NLFs will be conducted at each visit. High-resolution cutaneous ultrasound of injection sites will be performed at select visits and prior to study exit.
At least 3 subjects will be of Fitzpatrick skin type IV to VI, with at least 1 subject will be of skin type V-VI.
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
- 否
入选标准
- •Male or female of any race, 22 years of age or older, who are seeking therapy for correction of moderate to severe NLFs. Female subjects of childbearing potential must have a negative UPT at Visit 1 and practice a reliable method of contraception throughout the study.
- •Moderate to severe bilateral NLFs with a severity grading of 3 or 4 as per the Wrinkle Severity Rating Scale (WSRS). Each NLF must have the same WSRS grade.
- •Healthy skin in the study treatment area and free of conditions or diseases that could interfere with study evaluations.
- •Able to follow study instructions and complete all required visits.
- •Signed ICF, Photographic Release, HIPAA, and if applicable the California Experimental Research Subject's Bill of Rights.
排除标准
- •Female subjects that are pregnant, breast-feeding, or of childbearing potential and not practicing reliable contraception.
- •A condition or situation that puts the subject at significant risk, may confound the study results, or may significantly interfere with subjects' study participation.
- •Study staff or close relative to study staff (e.g., parents, children, siblings, or spouse).
- •Abnormal visual tests (i.e., Snellen acuity test worse than 20/40 with corrections, if applicable), abnormal confrontational visual field test, and/or abnormal ocular motility test.
- •Subjects with known prolonged bleeding times due to disease or anticoagulants (e.g., warfarin). If on a drug or supplement that prolongs bleeding times (e.g., non-steroidal anti-inflammatory, anticoagulant, high-dose vitamin E, fish oil, corticosteroids), wait 7 days or until bleeding times return to normal before injecting. (Note: low dose 81mg/day ASA is permitted).
- •Acute or chronic skin disease, inflammation, or related conditions, cancerous or precancerous lesions near the treatment area.
- •Presence of any skin pathology or condition that could interfere with the evaluation of the treatment areas, worsen due to study treatment, or require interfering topical, systemic or surgical therapy.
- •Herpes simplex lesion flare-ups greater than 6 per year.
- •Medical or psychiatric conditions that may increase the risk associated with study participation or may interfere with interpretation of study results or compliance of the subject and could make the subject inappropriate for study entry.
- •Known history of allergic/anaphylactic reactions to any of the components of CelluJuve® including known sensitivity to cellulose or local anesthetics of the amide type, history of multiple severe allergies, or history of anaphylactic shock.
- •Malignancy (excluding non-melanoma skin cancer) within the past 3 years.
- •History of systemic granulomatous diseases active or inactive (e.g., Sarcoid, Wegener's disease, TB, etc.) or connective tissue diseases (e.g., lupus, dermatomyositis, etc.).
- •History or evidence of keloid scarring, susceptibility to keloid formation or hypertrophic scarring, or delayed healing activity.
- •History or presence of severe chronic systemic diseases, including but not limited to, poorly controlled diabetes mellitus (all types), congestive heart failure, severe liver disease, severe kidney disease, and others as judged by the Investigator.
- •History or presence of any autoimmune or connective tissue disease, receiving treatment with immunomodulating therapy, or is immunocompromised or immunosuppressed.
- •Known history of clinically significant skin pigmentation disorders.
- •Clinically significant alcohol or drug abuse, or history of poor cooperation or unreliability.
- •Elective, clinically significant facial procedures that may confound the interpretation of the results in the NLF area (PI discretion), prior to study enrollment.
- •Physical attribute that may interfere with NLF assessment or treatment (e.g., facial hair, acne scarring, etc.).
- •Received a COVID-19 vaccine within 2 weeks of study entry.
- •Undergoing, or planning to undergo, radiation or ultrasound therapy in the treatment area.
- •History of any previous injectable filler to the study treatment area.
- •Exposure to any other investigational drug/device within 90 days of study entry or planning to participate in another investigation during the course of the study.
研究组 & 干预措施
CelluJuve®
CelluJuve® injected into left and right NLF
干预措施: CelluJuve® (Device)
结局指标
主要结局
Wrinkle Severity Rating Scale (WSRS)
时间窗: 2 months, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months, 24 months
Validated 5-point static scale assessing nasolabial fold (NLF) severity
Wrinkle Severity Rating Scale
时间窗: 2 months, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months, 24 months
5-point static scale ranging from 1-Absent to 5-Extreme
次要结局
未报告次要终点