Straberi Epistamp Device for Postinflammatory Hyperpigmentation
NCT ID: NCT04740255
Last Updated: 2023-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2022-12-23
2023-10-12
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Straberi Epistamp Needling Treatment
Non-Randomized treatment for patients with Postinflammatory Hyperpigmentation (PIH) using the Straberi Epistamp needling.
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
No Treatment
Non-Randomized patients with Postinflammatory Hyperpigmentation (PIH)
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
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
21 Years
65 Years
ALL
Yes
Sponsors
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Lavish Beauty
UNKNOWN
Universal Skincare Institute
OTHER
Responsible Party
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Principal Investigators
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Maurice E Wright, MD
Role: PRINCIPAL_INVESTIGATOR
Columbia University
Leslie L Nesbitt
Role: STUDY_CHAIR
Universal Skincare
Locations
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Lavish
New York, New York, United States
Countries
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References
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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.
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.
Related Links
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Description Derma Scan
Description Acne Scars Subtypes
Other Identifiers
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1115
Identifier Type: -
Identifier Source: org_study_id