First Submitted Date ICMJE September 15, 2020
First Posted Date ICMJE February 5, 2021
Last Update Posted Date February 5, 2021
Estimated Study Start Date ICMJE February 20, 2021
Estimated Primary Completion Date August 19, 2021 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE
(submitted: February 3, 2021)
Overall Skin improvement assessed by Derma Scan [ Time Frame: 6 months ]
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) [ Time Frame: 6 months ]
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.
The Global Aesthetic Improvement Scale (GAIS) [ Time Frame: 6 months ]
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.
Photographs [ Time Frame: 6 months ]
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) [ Time Frame: 6 months ]
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.
Original Primary Outcome Measures ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures ICMJE Not Provided
Original Secondary Outcome Measures ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided

Descriptive Information
Brief Title ICMJE Epistamp for Postinflammatory Hyperpigmentation
Official Title ICMJE Clinical Trial Study for the Use of Epistamp Needling Device to Treat Postinflammatory Hyperpigmentation (PIH)

Brief Summary This pilot study will expand knowledge and application needling using the Epistamp 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 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 ICMJE Interventional
Study Phase ICMJE Not Applicable
Study Design ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:
Participants in the Epistamp trial are those who are seeking improvement for Postinflammatory Hyperpigmentation (PIH) caused by acne.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition ICMJE Postinflammatory Hyperpigmentation
Intervention ICMJE Device: 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 Name: Needling
Study Arms ICMJE
Epistamp Needling Treatment Without RF
Non-Randomized treatment for patients with Postinflammatory Hyperpigmentation (PIH) using the Epistamp Needling without RF (Radio Frequency)
Intervention: Device: Epistamp
Epistamp Needling Treatment With RF
Non-Randomized treatment for patients with Postinflammatory Hyperpigmentation (PIH) using the Epistamp Needling with RF (Radio Frequency)
Intervention: Device: Epistamp
Publications *
Goodman GJ, Baron JA. Postacne scarring: a qualitative global scarring grading system. Dermatol Surg. 2006 Dec;32(12):1458-66.
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.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ICMJE Not yet recruiting
Estimated Enrollment ICMJE
(submitted: February 3, 2021) 30
Original Estimated Enrollment ICMJE Same as current
Estimated Study Completion Date ICMJE August 29, 2021
Estimated Primary Completion Date August 19, 2021 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE
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.
Needling 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.
Sex/Gender ICMJE
Sexes Eligible for Study: All
Ages ICMJE 18 Years to 65 Years (Adult, Older Adult)
Accepts Healthy Volunteers ICMJE Yes
Contacts ICMJE
Contact: Michelle Jenkins, Tech 6468384154 trials@universalskincareinstitute.com
Contact: Leslie Nesbitt 6468384154 trials@universalskincareinstitute.com
Listed Location Countries ICMJE United States
Removed Location Countries

Administrative Information
NCT Number ICMJE NCT04740255
Other Study ID Numbers ICMJE 1115
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement ICMJE
Plan to Share IPD: Undecided
Plan Description: Once the overall trial is completed and sensitive detailed information is legally advised to published.
Responsible Party Universal Skincare Institute
Study Sponsor ICMJE Universal Skincare Institute
Collaborators ICMJE Lavish Beauty
Investigators ICMJE
Principal Investigator: Maurice E Wright, MD Columbia University
Study Chair: Leslie L Nesbitt Universal Skincare
PRS Account Universal Skincare Institute
Verification Date February 2021