This pilot study will expand knowledge and application needling using the Straberi device for the improvement of Postinflammatory Hyperpigmentation (PIH) caused by acne.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
The patient's entire face will be treated. The following settings will be used as a treatment protocol. Needle length between .02- 1.55 mm
Lavish
New York, New York, United States
The Global Aesthetic Improvement Scale (GAIS)
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.
Time frame: 6 months
Overall Skin improvement assessed by Derma Scan
The Derma Scan System utilizes two special lighting systems (RGB +UV) and smart skin analyzer software that allows two images (before and after care) to be compared side by side, which can be used to detect the changes in skin
Time frame: 6 months
Overall Skin improvement assessed by Post Acne Hyperpigmentation Index (PAHPI)
The parameters of the scoring method are: median lesion size (S) (\<3mm, 3-6, 7-10, and \>10mm scored as 2, 4, 6, and 8, respectively), median lesion intensity (I) (slightly or moderately or significantly darker than surrounding skin scored as 3, 6, and 9, respectively), and number of lesions (N) (1-15, 16-30, 31-45, 46-60, and \>60 scored as 1-5, respectively). The score range from the total of S+I+N=6-22.
Time frame: 6 months
Photographs
Digital imaging device using a grid background with controlled lighting and setting to grade acne scar improvement on a quartile grading scale(1 = 1% to 25%, 2 = 26 to 50%, 3 = 51 to 75%, 4 = \>76% improvement).
Time frame: 6 months
To evaluate the impact on the quality of life (DLQI)
The Dermatology Life Quality Index questionnaire (DLQI) is 10 questions were asked to the patients and score is 0-3 for each question. The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.
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Time frame: 6 months