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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 microneedling device for the improvement of Atrophic Acne Scarring
This pilot study will expand the knowledge and application of needling using the Straberi microneedling device and its safety and benefits for improving the appearance of atrophic acne scarring. The pilot aims to objectively measure skin quality using the Derma Scan, photographs, and provide objective data showing improvement by way of the Goodman and Barons quantitative scar scale.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patiant without treatment | Other | Non-Randomized patients with atrophic acne skin conditions |
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| Straberi Microneedling Treatment | Other | Non-Randomized treatment for patients with atrophic acne skin conditions using the Straberi Microneedling device. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Straberi | Device | The patient's entire face will be treated with the Straberi microneedling devise. The following settings will be used as a treatment protocol. Needle length between .02- 1.55 mm |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Patient satisfaction of skin improvement assessed by the Goodman and Barons quantitative scar scale. | A global quantitative grading system for assessing the disease load and global severity of disease in a patient with post acne scarring. The Goodman and Baron score considers type of scar, number of scars, and severity of scarring and assigns a grade 1-4 with grade 1 representing mild, macular disease and grade 4 representing severe scarring that is obviously visible at social distances of 50cm, is not easily covered by makeup, and is not able to be flattened by manual stretching of the skin. Lower scores are favorable. Scale will be completed at every office visit over the 6 month study. | 6 months |
| 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 | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Skin changes 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 changes assessed by Acne Scar Subtypes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maurice E Wright, DR | Columbia University/ Harlem Hospital HHCNYC | Principal Investigator |
| Leslie L Nesbitt | Universal Skincare | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lavish Beauty | New York | New York | 10028 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8033378 | Background | 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. | |
| 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. |
| Label | URL |
|---|---|
| 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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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 17, 2025 | Oct 7, 2025 | 6 |
| 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 microneedling trial are those who are seeking improvement for atrophic acne scaring.
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Skin improvement assessed by Acne Scar Subtypes for improvement of acne scarring rolling, icepick, and or boxcar subtypes.Ice pick scars are narrow, sharply demarcated, V-shaped tracts, <2 mm in diameter, that extend into the deep dermis or even subcutaneous layer. Boxcar scars are wider (1-4 mm in diameter), U-shaped tracts, with sharp, vertical edges that extend 0.1-0.5 mm into the dermis. Rolling scars are characterised by dermal tethering of the dermis to the subcutis. They are generally ≥4 mm in diameter, irregular, with a rolling or undulating appearance.Scale will be completed at every office visit over the 6 month study. |
| 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 |
| Atrophic Scars Subtypes | View source |
| D012046 |
| Rehabilitation |