Clinical Trial Study for the Use of Straberi Epistamp Needling Device to Treat Postinflammatory Hyperpigmentation (PIH)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The Global Aesthetic Improvement Scale (GAIS)
研究概览
简要总结
This pilot study will expand knowledge and application needling using the Straberi device for the improvement of Postinflammatory Hyperpigmentation (PIH) caused by acne.
详细描述
This pilot study will expand the knowledge and application of needling using the Straberi Epistamp device and its safety and benefits for improving the appearance of Postinflammatory Hyperpigmentation. Postinflammatory Hyperpigmentation (PIH) caused by acne is a common inflammatory disease that can adversely affect facial appearance. Facial acne can have a serious negative impact on psychosocial functioning leaving deep emotional scars. Severe acne can also lead to physical scars and disfigurement. Among patients with severe acne, facial scarring affects both genders equally and occurs to some degree in 95% of cases.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Derma Scan showing aging including skin texture, wrinkles, brown spots, and pores.
- •Patients willing to sign informed consent.
- •Patients willing to be photographed and video documented
- •Patients willing to consent to 3 months of treatment
排除标准
- •History of eczema in the treatment area; psoriasis and any other chronic skin conditions
- •History of actinic (solar) keratosis in the treatment area;
- •History of hemophilia
- •History of diabetes
- •The presence of raised moles, warts on the targeted area.
- •Collagen vascular diseases or cardiac abnormalities
- •Blood clotting problems
- •Active bacterial or fungal infection
- •Facial melanosis
- •Malignant tumors
- •Immunosuppression
- •Use of blood thinners or prednisone
- •Corticosteroids within two weeks of the procedure
- •Chronic liver disease
- •Porphyria or other skin diseases.
- •Patient not willing to sign informed consent.
- •TCA peels in the last 5 weeks
- •Subject currently has moderate to severe acne on the face.
- •Microneedling within the last 6 months
- •Subject has an active infection.
- •Subject has a history of a bleeding disorder
- •Subject has a history of keloidal tendency
- •Subject has received ablative or non-ablative laser treatments in the previous 6 months.
- •Subject has taken Accutane within the previous 3 months.
结局指标
主要结局
The Global Aesthetic Improvement Scale (GAIS)
时间窗: 6 months
The Global Aesthetic Improvement Scale (GAIS) is a 5-point scale rating global aesthetic improvement in appearance, compared to pretreatment, as judged by the investigator 5 point scale ranging from 1 to 5 with 5 = The appearance has worsen compared with the original condition and 1 = Excellent corrective results compared to pretreatment, as judged by the investigator.
次要结局
- To evaluate the impact on the quality of life (DLQI)(6 months)
- Overall Skin improvement assessed by Derma Scan(6 months)
- Overall Skin improvement assessed by Post Acne Hyperpigmentation Index (PAHPI)(6 months)
- Photographs(6 months)