NCT00795327已完成不适用
The Canadian Study of the Use of Injectable Poly-L-Lactic Acid Dermal Implant for the Treatment of Hill and Valley Acne Scarring
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Physician Scar Improvement Scale (PSIS)
研究概览
简要总结
Primary:
Evaluate the degree of correction attainable with Poly-L-Lactic Acid(Sculptra) for the correction of hill and valley acne scarring
Secondary:
Document types and incidence of device adverse events with Poly-L-Lactic Acid(Sculptra) therapy.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Outpatient seeking therapy for correction of hill and valley acne scarring.
- •Ability and willingness to understand and comply with requirements of the trial
排除标准
- •The subject has active acne or chronic skin disease, inflammation or related conditions, such as infection, psoriasis and herpes zoster
- •History of presence of keloid formation or hypertrophic scars
- •History of procedures that precipitate an active dermal inflammatory or hyperplastic response (i.e., epilation or radiofrequency laser and chemical peeling procedures) within one month of study entry
- •History of use of facial tissue augmenting therapy or aesthetic facial surgical therapy within six months prior to study entry
- •Concomitant anticoagulant therapy, antiplatelet therapy or has any bleeding disorders
- •History of unanticipated adverse reactions when treated with hyaluronic acid based products
- •Any condition which in the opinion of the investigator makes the patient unable to complete the study per protocol (e.g., patients not likely to avoid other facial cosmetic treatments; patients not likely to stay in the study for its duration because of other commitments, concomitant conditions, or past history; patients anticipated to be unreliable, or patients who have a concomitant condition that may develop symptoms that might confuse or confound study treatments or assessments)
- •History of or current cancerous or pre-cancerous lesions in the area to be treated
- •Use of any investigational drugs or any other medical devices within 30 days of enrolment
- •Use of any prohibited medication within a proscribed time period before entry
- •Pregnancy
- •Recent use of Accutane (patient should not be on Accutane for the last 6 months)
- •History of allergic/anaphylactic reactions, including hypersensitivity to local anaesthetics (lidocaine)
- •Recent history of trauma in the face (less that 1 year)
- •Previous of Dermalive or Dermadeep
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
结局指标
主要结局
Physician Scar Improvement Scale (PSIS)
时间窗: At each visit
Self-Assessed Scar Improvement Scale (SASIS).
时间窗: At each visit
次要结局
- Degree of subject satisfaction with treatment(At each Visit)
- Adverse events(At each visit)
研究者
研究点 (1)
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