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Epistamp for Postinflammatory Hyperpigmentation (EPH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04740255
Recruitment Status : Not yet recruiting
First Posted : February 5, 2021
Last Update Posted : April 5, 2021
Sponsor:
Collaborator:
Lavish Beauty
Information provided by (Responsible Party):
Universal Skincare Institute

Study Description
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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.

Condition or disease Intervention/treatment Phase
Postinflammatory Hyperpigmentation Device: Epistamp Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
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
Official Title: Clinical Trial Study for the Use of Epistamp Needling Device to Treat Postinflammatory Hyperpigmentation (PIH)
Estimated Study Start Date : April 20, 2021
Estimated Primary Completion Date : September 19, 2021
Estimated Study Completion Date : September 29, 2021
Arms and Interventions
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Arm Intervention/treatment
Epistamp Needling Treatment Without RF
Non-Randomized treatment for patients with Postinflammatory Hyperpigmentation (PIH) using the Epistamp needling without RF (Radio Frequency)
 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: Microneedling
Epistamp Microneedling Treatment With RF
Non-Randomized treatment for patients with Postinflammatory Hyperpigmentation (PIH) using the Epistamp needling with RF (Radio Frequency)
 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: Microneedling


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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.

  3. 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.


  4. 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).

  5. 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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04740255


Contacts
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Contact: Michelle Jenkins, Tech 6468384154 trials@universalskincareinstitute.com
Contact: Leslie Nesbitt 6468384154 trials@universalskincareinstitute.com

Locations
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United States, New York
Lavish
New York, New York, United States, 10028
Contact: Steven Wong, MD    646-838-4154    info@universalskincareinstitute.com   
Contact: Leslie Nesbitt         
Sponsors and Collaborators
Universal Skincare Institute
Lavish Beauty
Investigators
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Principal Investigator: Maurice E Wright, MD Columbia University
Study Chair: Leslie L Nesbitt Universal Skincare
More Information
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Additional Information:

Publications of Results:

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Responsible Party: Universal Skincare Institute
ClinicalTrials.gov Identifier: NCT04740255    
Other Study ID Numbers: 1115
First Posted: February 5, 2021    Key Record Dates
Last Update Posted: April 5, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Once the overall trial is completed and sensitive detailed information is legally advised to published.

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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
Keywords provided by Universal Skincare Institute:
needling
postinflammatory hyperpigmentation
Epistamp
Universal Skincare Institute
Additional relevant MeSH terms:
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Hyperpigmentation
Pigmentation Disorders
Skin Diseases