Straberi Epistamp Needling Treatment For Skin Rejuvenation (ESAA)
Primary Purpose
Wrinkle, Elastic Skin, Collagen Degeneration
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Straberi Epistamp Microneedling Treatment
Sponsored by
About this trial
This is an interventional treatment trial for Wrinkle focused on measuring microneedling
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.
Sites / Locations
- LavishRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Straberi Epistamp Needling Treatment
No Treatment
Arm Description
Non-Randomized treatment for patients who seek improvement for elastin, fine lines, deep wrinkles, and collagen production using Straberi Epistamp needling treatment
Non-Randomized patients who seek improvement for elastin, fine lines, deep wrinkles, and collagen production.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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).
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.
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.
Full Information
NCT ID
NCT04742803
First Posted
October 1, 2020
Last Updated
January 17, 2023
Sponsor
Universal Skincare Institute
Collaborators
Lavish Beauty
1. Study Identification
Unique Protocol Identification Number
NCT04742803
Brief Title
Straberi Epistamp Needling Treatment For Skin Rejuvenation
Acronym
ESAA
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
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 23, 2022 (Actual)
Primary Completion Date
May 2, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universal Skincare Institute
Collaborators
Lavish Beauty
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wrinkle, Elastic Skin, Collagen Degeneration
Keywords
microneedling
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Straberi Epistamp Needling Treatment
Arm Type
Other
Arm Description
Non-Randomized treatment for patients who seek improvement for elastin, fine lines, deep wrinkles, and collagen production using Straberi Epistamp needling treatment
Arm Title
No Treatment
Arm Type
Other
Arm Description
Non-Randomized patients who seek improvement for elastin, fine lines, deep wrinkles, and collagen production.
Intervention Type
Device
Intervention Name(s)
Straberi Epistamp Microneedling Treatment
Other Intervention Name(s)
Needling
Intervention Description
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
Primary Outcome Measure Information:
Title
The Global Aesthetic Improvement Scale (GAIS)
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Overall Skin improvement assessed by Derma Scan
Description
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.
Time Frame
6 months
Title
Photographs
Description
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).
Time Frame
6 months
Title
To evaluate the impact on the quality of life (DLQI)
Description
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.
Time Frame
6 months
Title
Wrinkle Severity Rating Scale (WSRS)
Description
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.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Steven Wong, MD
Phone
6468384154
Ext
3
Email
trials@universalskincareinstitute.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maurice Wright, MD
Organizational Affiliation
Columbia University/ Harlem Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Leslie L Nesbitt
Organizational Affiliation
Universal Skincare
Official's Role
Study Chair
Facility Information:
Facility Name
Lavish
City
New York
State/Province
New York
ZIP/Postal Code
10028
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leslie Nesbitt, Tech
Phone
646-838-4154
Email
trials@universalskincareinstitute.com
First Name & Middle Initial & Last Name & Degree
Steven Wong, MD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Once the overall trial is completed and sensitive detailed information is legally advised to published.
Citations:
PubMed Identifier
17199653
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.
Results Reference
background
PubMed Identifier
8033378
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.
Results Reference
background
Links:
URL
http://universalskincareinstitute.com/
Description
Derma Scan
Learn more about this trial
Straberi Epistamp Needling Treatment For Skin Rejuvenation
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