Straberi Epistamp Device for Postinflammatory Hyperpigmentation

Postinflammatory Hyperpigmentation Clinical Trial

— EPH  

Official title:

Clinical Trial Study for the Use of Straberi Epistamp Needling Device to Treat Postinflammatory Hyperpigmentation (PIH)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04740255
• Other study ID #: 1115
• Status: Completed
• Phase: N/A
• Start date: December 23, 2022
• Est. completion date: October 12, 2023

Study information

• Verified date: January 2023
• Source: Universal Skincare Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 12, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hyperpigmentation
• Postinflammatory Hyperpigmentation

Intervention

Device:
• 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

Locations

Country	Name	City	State
United States	Lavish	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Universal Skincare Institute	Lavish Beauty

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Global Aesthetic Improvement Scale (GAIS)	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.	6 months
Secondary	Overall Skin improvement assessed by Derma Scan	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	6 months
Secondary	Overall Skin improvement assessed by Post Acne Hyperpigmentation Index (PAHPI)	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.	6 months
Secondary	Photographs	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).	6 months
Secondary	To evaluate the impact on the quality of life (DLQI)	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.	6 months

External Links

•   Description Acne Scars Subtypes
•   Description Derma Scan