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Straberi Epistamp Device for Postinflammatory Hyperpigmentation (EPH)

Primary Purpose

Postinflammatory Hyperpigmentation

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Straberi Epistamp
Sponsored by
Universal Skincare Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postinflammatory Hyperpigmentation focused on measuring needling, postinflammatory hyperpigmentation, Epistamp, Universal Skincare Institute

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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 with Postinflammatory Hyperpigmentation (PIH) using the Straberi Epistamp needling.

Non-Randomized patients with Postinflammatory Hyperpigmentation (PIH)

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 compared to pretreatment, as judged by the 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
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.
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.

Full Information

First Posted
September 15, 2020
Last Updated
January 17, 2023
Sponsor
Universal Skincare Institute
Collaborators
Lavish Beauty
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1. Study Identification

Unique Protocol Identification Number
NCT04740255
Brief Title
Straberi Epistamp Device for Postinflammatory Hyperpigmentation
Acronym
EPH
Official Title
Clinical Trial Study for the Use of Straberi Epistamp Needling Device to Treat Postinflammatory Hyperpigmentation (PIH)
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 30, 2023 (Anticipated)
Study Completion Date
June 3, 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 Straberi device for the improvement of Postinflammatory Hyperpigmentation (PIH) caused by acne.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postinflammatory Hyperpigmentation
Keywords
needling, postinflammatory hyperpigmentation, Epistamp, Universal Skincare Institute

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Participants in the Straberi by Epistamp device trial, are those who are seeking improvement for Postinflammatory Hyperpigmentation (PIH) caused by acne.
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 with Postinflammatory Hyperpigmentation (PIH) using the Straberi Epistamp needling.
Arm Title
No Treatment
Arm Type
Other
Arm Description
Non-Randomized patients with Postinflammatory Hyperpigmentation (PIH)
Intervention Type
Device
Intervention Name(s)
Straberi Epistamp
Other Intervention Name(s)
Microneedling
Intervention Description
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
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 compared to pretreatment, as judged by the 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
Overall Skin improvement assessed by Post Acne Hyperpigmentation Index (PAHPI)
Description
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.
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

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
Email
trials@universalskincareinstitute.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maurice E Wright, MD
Organizational Affiliation
Columbia University
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
Steven Wong, MD
Phone
646-838-4154
Email
info@universalskincareinstitute.com
First Name & Middle Initial & Last Name & Degree
Leslie Nesbitt

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
result
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
result
Links:
URL
http://universalskincareinstitute.com/
Description
Description Derma Scan
URL
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2958495/
Description
Description Acne Scars Subtypes

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Straberi Epistamp Device for Postinflammatory Hyperpigmentation

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