Clinical trial NCT04742803: Straberi Epistamp Needling Treatment For Skin Rejuvenation
Official title: Face Study of the Effects of Needling Using the Straberi Epistamp for the Improvement of Fine Lines and Skin Laxity.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wrinkle
Elastic Skin
Collagen Degeneration
Keywords: microneedling
Lead sponsor: Universal Skincare Institute
Sponsor class: OTHER
Collaborators: name: Lavish Beauty
First posted: 2021-02-08
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The Global Aesthetic Improvement Scale (GAIS)
timeFrame: 6 months
Secondary outcomes:
measure: Overall Skin improvement assessed by Derma Scan
timeFrame: 6 months
measure: Photographs
timeFrame: 6 months
measure: To evaluate the impact on the quality of life (DLQI)
timeFrame: 6 months
measure: Wrinkle Severity Rating Scale (WSRS)
timeFrame: 6 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Lavish
state: New York
Study officials:
affiliation: Columbia University/ Harlem Hospital
name: Maurice Wright, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universal Skincare
name: Leslie L Nesbitt
role: STUDY_CHAIR
References:
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.
citation: 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.