Clinical trial NCT04740255: Straberi Epistamp Device for Postinflammatory Hyperpigmentation
Official title: Clinical Trial Study for the Use of Straberi Epistamp Needling Device to Treat Postinflammatory Hyperpigmentation (PIH)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postinflammatory Hyperpigmentation
Keywords: needling
postinflammatory hyperpigmentation
Epistamp
Universal Skincare Institute
Lead sponsor: Universal Skincare Institute
Sponsor class: OTHER
Collaborators: name: Lavish Beauty
First posted: 2021-02-05
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Participants in the Straberi by Epistamp device trial, are those who are seeking improvement for Postinflammatory Hyperpigmentation (PIH) caused by acne.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: The Global Aesthetic Improvement Scale (GAIS)
timeFrame: 6 months
Secondary outcomes:
measure: Overall Skin improvement assessed by Derma Scan
timeFrame: 6 months
measure: Overall Skin improvement assessed by Post Acne Hyperpigmentation Index (PAHPI)
timeFrame: 6 months
measure: Photographs
timeFrame: 6 months
measure: To evaluate the impact on the quality of life (DLQI)
timeFrame: 6 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Lavish
state: New York
Study officials:
affiliation: Columbia University
name: Maurice E Wright, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universal Skincare
name: Leslie L Nesbitt
role: STUDY_CHAIR
References:
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.
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.