Straberi Epistamp Device for Postinflammatory Hyperpigmentation (EPH)

Clinical Trial Study for the Use of Straberi Epistamp Needling Device to Treat Postinflammatory Hyperpigmentation (PIH)

This pilot study will expand knowledge and application needling using the Straberi device for the improvement of Postinflammatory Hyperpigmentation (PIH) caused by acne.

Study Overview

• Status: Completed
• Conditions: Postinflammatory Hyperpigmentation
• Intervention / Treatment: Device: Straberi Epistamp

Detailed Description

This pilot study will expand the knowledge and application of needling using the Straberi Epistamp device and its safety and benefits for improving the appearance of Postinflammatory Hyperpigmentation. Postinflammatory Hyperpigmentation (PIH) caused by acne is a common inflammatory disease that can adversely affect facial appearance. Facial acne can have a serious negative impact on psychosocial functioning leaving deep emotional scars. Severe acne can also lead to physical scars and disfigurement. Among patients with severe acne, facial scarring affects both genders equally and occurs to some degree in 95% of cases.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

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

Study Locations

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

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: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Straberi Epistamp Needling Treatment; Non-Randomized treatment for patients with Postinflammatory Hyperpigmentation (PIH) using the Straberi Epistamp needling.	Device: Straberi Epistamp; The patient's entire face will be treated. The following settings will be used as a treatment protocol. Needle length between .02- 1.55 mm; Other Names: Microneedling
Other: No Treatment; Non-Randomized patients with Postinflammatory Hyperpigmentation (PIH)	Device: Straberi Epistamp; The patient's entire face will be treated. 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
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 compared to pretreatment, as judged by the investigator.	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 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
Overall Skin improvement assessed by Post Acne Hyperpigmentation Index (PAHPI)	The parameters of the scoring method are: median lesion size (S) (<3mm, 3-6, 7-10, and >10mm scored as 2, 4, 6, and 8, respectively), median lesion intensity (I) (slightly or moderately or significantly darker than surrounding skin scored as 3, 6, and 9, respectively), and number of lesions (N) (1-15, 16-30, 31-45, 46-60, and >60 scored as 1-5, respectively). The score range from the total of S+I+N=6-22.	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, MD, Columbia University

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

• Description Derma Scan
• Description Acne 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 15, 2020
• First Submitted That Met QC Criteria: February 3, 2021
• First Posted (Actual): February 5, 2021

Study Record Updates

• Last Update Posted (Estimated): 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: needling; postinflammatory hyperpigmentation; Epistamp; Universal Skincare Institute
• Additional Relevant MeSH Terms: Skin Diseases; Pigmentation Disorders; Hyperpigmentation
• Other Study ID Numbers: 1115

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