Straberi Epistamp Device for Postinflammatory Hyperpigmentation

Study Overview
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Brief Summary
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This pilot study will expand knowledge and application needling using the Straberi device for the improvement of Postinflammatory Hyperpigmentation (PIH) caused by acne.

Detailed Description
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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.

Official Title
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Clinical Trial Study for the Use of Straberi Epistamp Needling Device to Treat Postinflammatory Hyperpigmentation (PIH)

Conditions
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Postinflammatory Hyperpigmentation

Intervention / Treatment
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* Device: Straberi Epistamp


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Participants in the Straberi by Epistamp device trial, are those who are seeking improvement for Postinflammatory Hyperpigmentation (PIH) caused by acne.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Straberi Epistamp Needling Treatment<br>Non-Randomized treatment for patients with Postinflammatory Hyperpigmentation (PIH) using the Straberi Epistamp needling. | Device: Straberi Epistamp<br>* 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<br>* Other names: Microneedling;|
| Other: No Treatment<br>Non-Randomized patients with Postinflammatory Hyperpigmentation (PIH) | Device: Straberi Epistamp<br>* 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<br>* Other names: Microneedling;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 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). | 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. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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needling, postinflammatory hyperpigmentation, Epistamp, Universal Skincare Institute