Straberi Epistamp Device for Postinflammatory Hyperpigmentation (EPH)

Universal Skincare Institute

Status: Completed

Conditions: Postinflammatory Hyperpigmentation

Treatments: Device: Straberi Epistamp

Study type: Interventional

Funder types: Other

Identifiers

NCT04740255

1115

Details and patient eligibility

About

This pilot study will expand knowledge and application needling using the Straberi device for the improvement of Postinflammatory Hyperpigmentation (PIH) caused by acne.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Straberi Epistamp Needling Treatment

Other group

Description:

Non-Randomized treatment for patients with Postinflammatory Hyperpigmentation (PIH) using the Straberi Epistamp needling.

Treatment:

Device: Straberi Epistamp

No Treatment

Other group

Description:

Non-Randomized patients with Postinflammatory Hyperpigmentation (PIH)

Treatment:

Device: Straberi Epistamp