Wrinkle Clinical Trial
— ESAAOfficial title:
Face Study of the Effects of Needling Using the Straberi Epistamp for the Improvement of Fine Lines and Skin Laxity.
NCT number | NCT04742803 |
Other study ID # | 1116 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | December 23, 2022 |
Est. completion date | October 12, 2023 |
Verified date | December 2023 |
Source | Universal Skincare Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This pilot study will expand knowledge and application needling using the Epistamp device for the improvement of a new vitalized epidermal layer with new vibrant active cells, supported by more robust collagen and elastin fine lines, deep wrinkles, and collagen production.
Status | Completed |
Enrollment | 30 |
Est. completion date | October 12, 2023 |
Est. primary completion date | June 30, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 21 Years to 65 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Lavish | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Universal Skincare Institute | Lavish Beauty |
United States,
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 investigator. | 6 months | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Wrinkle Severity Rating Scale (WSRS) | The Wrinkle Severity Rating Scale assesses the presence and severity of wrinkles at rest in a rating scale from 0 to 4, where 0 means no visible wrinkles, 1 means minimal wrinkles, 2 means shallow wrinkles, 3 means moderately deep wrinkles and 4 means very deep wrinkles. | 6 months |
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