Lavish
New York, 10028, United States
NCT Number: NCT04740255
This pilot study will expand knowledge and application needling using the Straberi device for the improvement of Postinflammatory Hyperpigmentation (PIH) caused by acne.
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Notify Me21 year–65 year
All sexes
Interventional
Not applicable
New York, 10028, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Other names: Microneedling
Time frame: 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.
Time frame: 6 months
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
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
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
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.
Universal Skincare Institute
Other
Clinical Trial Study for the Use of Straberi Epistamp Needling Device to Treat Postinflammatory Hyperpigmentation (PIH)
Acronym: EPH
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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