Double Blind Split Face Randomized Placebo Controlled Clinical Trial Investigating Juvederm Vollure for the Correction of Atrophic Facial Scarring
试验速览
- 阶段
- 不适用
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Quantitiative Global Scaring Grading System (QGSGS) score
研究概览
简要总结
Subjects will be randomized to receive up to 1cc of Juvéderm Vollure on one side of their face and up to 1cc of Saline on the other. On Day 30, this treatment with the same left-right assignment can be repeated. Subjects will return 24-48 hours after their first treatment to fill out questionnaires, take pictures, and to be assessed by blinded evaluators regarding short term adverse events. Subjects will fill out a 30 day subject diary and also return 30 and 90 days after their last treatment to fill out questionnaires, take pictures, complete the Global Aesthetic Improvement Scale (GAIS), and to be assessed on the QGSGS and for long-term adverse events by blinded evaluators. At 12 months, 18 months, and 24 months, the subjects will return to fill out questionnaires, take pictures, and to be assessed by blinded evaluators for long-term efficacy.
详细描述
Subjects with grades ranging from 4-55 on the Quantitative Global Scarring Grading System (QGSGS)1 will be randomized to receive up to 1cc of Juvéderm Vollure on one side of their face and up to 1cc of Saline on the other. On Day 30, this treatment with the same left-right assignment can be repeated if optimal correction on the active intervention side has not been achieved according to the treating investigator. Subjects will return 24-48 hours after their first treatment to fill out questionnaires, take pictures, and to be assessed by blinded evaluators regarding short term adverse events. Subjects will fill out a 30 day subject diary and also return 30 and 90 days after their last treatment to fill out questionnaires, take pictures, complete the Global Aesthetic Improvement Scale (GAIS), and to be assessed on the QGSGS and for long-term adverse events by blinded evaluators. The subjects will be eligible to receive treatment with Juvéderm Vollure 90 days after their last treatment on the placebo-controlled side if they choose. In addition, at 12 months, 18 months, and 24 months, the subjects will return to fill out questionnaires, take pictures, and to be assessed by blinded evaluators for long-term efficacy.
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
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •In good general health as evidenced by medical history
- •For females of reproductive potential: use of highly effective contraception and a negative urine pregnancy test at screening and all injection visits.
- •Score of 4-55 on a validated scarring grading system
排除标准
- •Subjects with allergies to hyaluronic acid filler, gram positive bacteria or lidocaine.
- •Subjects with auto-immune conditions
- •Subjects with diabetes
- •Subjects with a history of sever anaphylactic reactions
- •Subjects with cancer, or other life-threatening medical condition
- •Subjects taking anti---coagulants, chemotherapy, immunosuppressive agents, immunomodulatory agents, diuretics, anti---histamines, or anti---inflammatory medications in the 2 weeks prior to the study or who will need to take these medications at any time during the first 120 days of the study.
- •Subjects with any scheduled laser, light, or surgical procedures during the study, including dental surgery.
- •Subjects who had neuromodulators in the past 6 months or hyaluronic acid fillers in the previous year on the face
- •Subjects who at any time had surgery or more permanent fillers in the face such as Bellafill or Radiesse
- •Subjects with tattoos or many skin growths on the face that would obscure visualization of the scars
- •Subjects with a history of keloid or hypertrophic scar on the face
- •Subjects unwilling or unable to sit still while an injector places Juvéderm Vollure in the face
- •Subjects unwilling or unable to keep their head still during the photos
- •Subjects who are pregnant or nursing
- •Female subjects of child-bearing potential unable to take or use some form of birth control
- •Subjects with any facial bruising or swelling
- •Subjects with current skin infections, tumors, herpes outbreak or dermatitis on the face
- •Subjects using skin-irritating topical preparations, pigmenting agents (self-tanning or bleaching creams), in the past two weeks or for the first 120 days of the study on the face
- •Any medical condition that in the opinion of the Investigator would make the subject unsuitable for inclusion
- •Women who are pregnant or breast feeding, or women of childbearing potential who are not practicing adequate contraception or planning to become pregnant during the study period.
- •Study site personnel, close relatives of the study site personnel (e.g. parents, children, siblings, or spouse), employees, or close relatives of employee.
结局指标
主要结局
Quantitiative Global Scaring Grading System (QGSGS) score
时间窗: Baseline to 90 days after last injection
Difference in the mean QGSGS score from baseline to 90 days after injection in active group. The QGSGS score ranges from 0 to 84 and a higher score signifies a worse condition.
次要结局
- Global Aesthetic Improvement Scale (GAIS)(Baseline to 90 days after last injection)
- 24 Month Global Aesthetic Improvement Scale (GAIS) Results(24 months after 1st injection)
- Result of Placebo Group based on the Quantitiative Global Scaring Grading System (QGSGS)(Baseline to 90 days after last injection)
- Adverse Events(Baseline to 90 days after last injection)
- 24 Month Quantitiative Global Scaring Grading System (QGSGS) Results(24 months after 1st injection)