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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date December 2023
Source Universal Skincare Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

This pilot study will expand the knowledge and application needling using the Epistamp device and its benefits for improving the appearance of fine lines, deep wrinkles, and collagen production. The pilot aims to objectively measure skin quality using the Derma Scan, photographs and provide objective data showing improvement by way of the Universal Skincare Institute Blood Flow Scale.


Recruitment information / eligibility

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.

Study Design


Intervention

Device:
Straberi Epistamp Microneedling Treatment
The patient's entire face will be treated with the Straberi Epistamp needling device. The following settings will be used as a treatment protocol. Needle length between .02- 1.55 mm

Locations

Country Name City State
United States Lavish New York New York

Sponsors (2)

Lead Sponsor Collaborator
Universal Skincare Institute Lavish Beauty

Country where clinical trial is conducted

United States, 

References & Publications (2)

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

Outcome

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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