Straberi Microneedling For Atrophic Acne (SAA)

Clinical Trial Study for the Use of Straberi Microneedling Device to Treat Atrophic Acne Scarring

This pilot study will expand knowledge and application needling using the Straberi microneedling device for the improvement of Atrophic Acne Scarring

Study Overview

• Status: Completed
• Conditions: Atrophic Acne Scar
• Intervention / Treatment: Device: Straberi

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Steven Wong, DR; Phone Number: 6468384154; Email: trials@universalskincareinstitute.com

Study Locations

• United States
  • New York
    • New York, New York, United States, 10028
      • Lavish Beauty

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Patiant without treatment; Non-Randomized patients with atrophic acne skin conditions	Device: Straberi; 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; Other Names: microneedling
Other: Straberi Microneedling Treatment; Non-Randomized treatment for patients with atrophic acne skin conditions using the Straberi Microneedling device.	Device: Straberi; 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; Other Names: microneedling

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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	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

Collaborators and Investigators

• Sponsor: Universal Skincare Institute
• Collaborators: Lavish Beauty
• Investigators: Study Chair: Leslie L Nesbitt, Universal Skincare; Principal Investigator: Maurice E Wright, DR, Columbia University/ Harlem Hospital HHCNYC

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

• Derma Scan
• Atrophic Scars Subtypes

Study record dates

Study Major Dates

• Study Start (Actual): December 23, 2022
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): October 12, 2023

Study Registration Dates

• First Submitted: September 13, 2020
• First Submitted That Met QC Criteria: February 3, 2021
• First Posted (Actual): February 5, 2021

Study Record Updates

• Last Update Posted (Actual): December 6, 2023
• Last Update Submitted That Met QC Criteria: December 4, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: microneedling; atrophic acne; epistamp; universal skincare institute
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Atrophy
• Other Study ID Numbers: 1114

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Once the overall trial is completed and sensitive detailed information is legally advised to published.

Drug and device information, study documents

• 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