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| Name | Class |
|---|---|
| Lavish Beauty | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Straberi Epistamp Needling Treatment | Other | Non-Randomized treatment for patients with Postinflammatory Hyperpigmentation (PIH) using the Straberi Epistamp needling. |
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| No Treatment | Other | Non-Randomized patients with Postinflammatory Hyperpigmentation (PIH) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Straberi Epistamp | Device | 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 |
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maurice E Wright, MD | Columbia University | Principal Investigator |
| Leslie L Nesbitt | Universal Skincare | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lavish | New York | New York | 10028 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17199653 | Result | Goodman GJ, Baron JA. Postacne scarring: a qualitative global scarring grading system. Dermatol Surg. 2006 Dec;32(12):1458-66. doi: 10.1111/j.1524-4725.2006.32354.x. | |
| 8033378 | Result | Finlay AY, Khan GK. Dermatology Life Quality Index (DLQI)--a simple practical measure for routine clinical use. Clin Exp Dermatol. 1994 May;19(3):210-6. doi: 10.1111/j.1365-2230.1994.tb01167.x. |
| Label | URL |
|---|---|
| Description Derma Scan | View source |
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Once the overall trial is completed and sensitive detailed information is legally advised to published.
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 18, 2025 | |
| Reset | Oct 7, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 18, 2025 | Oct 7, 2025 |
| ID | Term |
|---|---|
| D017495 | Hyperpigmentation |
| ID | Term |
|---|---|
| D010859 | Pigmentation Disorders |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000097244 | Percutaneous Collagen Induction |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D011677 | Punctures |
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Participants in the Straberi by Epistamp device trial, are those who are seeking improvement for Postinflammatory Hyperpigmentation (PIH) caused by acne.
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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 |
| Description Acne Scars Subtypes | View source |
| D012046 |
| Rehabilitation |