Safety and Efficacy Study of Isolagen TherapyTM in the Treatment of Nasolabial Fold Wrinkles
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 203
- 试验地点
- 8
- 主要终点
- Subject Wrinkle Assessment Responders
研究概览
简要总结
The purpose of this study is to evaluate the safety profile and the treatment effect of Isolagen TherapyTM compared with placebo when administered to bilateral nasolabial fold wrinkles.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is at least 18 years of age
- •Level of severity of bilateral nasolabial fold wrinkles meeting severity criteria as per protocol
- •Level of subject dissatisfaction with both nasolabial fold wrinkles as per protocol
- •Ability to comply with the study requirements
- •Negative pregnancy test (Females)
- •Healthy post-auricular skin for biopsy
排除标准
- •Excessive dermatochalasis of the treatment area
- •Inability to lessen the nasolabial fold wrinkles by physically spreading the area apart
- •Total area to be treated exceeds 20 cm in length
- •Physical attributes which may prevent assessment or treatment as judged by the evaluator
- •Use of an investigational product/procedure within 30 days prior to enrollment or plans for use during the study
- •Previous treatment with the sponsor's product
- •History of active autoimmune disease or organ transplantation
- •Diagnosis of cancer, unless successfully treated or in remission (basal cell carcinoma is excluded)
- •Active or chronic skin disease
- •Known genetic disorders affecting fibroblasts or collagen
- •Active systemic infection
- •Requires chronic antibiotic or steroidal therapy
- •Use of certain commercial products/procedures to the treatment area prior to study enrollment or plans for use during the study
- •Use of systemic agents that increase bleeding or clotting, or disorders equated with these effects
- •Known allergic reactions to agents used in preparation of treatment
- •Excessive exposure to sun without adequate sun protection
结局指标
主要结局
Subject Wrinkle Assessment Responders
时间窗: Baseline (prior to first treatment) and 6 months post final treatment
A two point improvement on the Subject's live assessment of the wrinkles of the lower part of the face as compared to baseline on the Subject Wrinkle Assessment was considered a responder. The Subject Wrinkle Assessment scale was a five point scale with a score of -2 (Very Dissatisfied) being the worst and a score of +2 (Very Satisfied) being the best.
Evaluator Wrinkle Severity Assessment Responders
时间窗: Baseline (prior to first treatment) and 6 months after last treatment
A responder was defined as a two point improvement on the blinded Evaluator's live assessment of each of the bilateral nasolabial fold wrinkles at rest using the 6-point ordinal Lemperle Wrinkle Severity Scale. On the Lemperle scale, a score of 5 (Very Deep Wrinkle) is worst and a score of 0 (No Visible Wrinkle) is best.
次要结局
- Evaluator Wrinkle Severity Assessment Responders(Baseline (prior to first treatment) compared to 3rd treatment visit, 2 and 4 months post final treatment)
- Subject Wrinkle Assessment Responders(Baseline (prior to first treatment) compared to 3rd treatment visit, 2 and 4 months post final treatment)