Straberi Epistamp Needling Treatment For Skin Rejuvenation

NCT ID: NCT04742803

Last Updated: 2023-12-06

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-23

Study Completion Date

2023-10-12

Brief Summary

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This pilot study will expand knowledge and application needling using the Epistamp device for the improvement of a new vitalized epidermal layer with new vibrant active cells, supported by more robust collagen and elastin fine lines, deep wrinkles, and collagen production.

Detailed Description

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This pilot study will expand the knowledge and application needling using the Epistamp device and its benefits for improving the appearance of fine lines, deep wrinkles, and collagen production. The pilot aims to objectively measure skin quality using the Derma Scan, photographs and provide objective data showing improvement by way of the Universal Skincare Institute Blood Flow Scale.

Conditions

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Wrinkle Elastic Skin Collagen Degeneration

Keywords

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microneedling

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Straberi Epistamp Needling Treatment

Non-Randomized treatment for patients who seek improvement for elastin, fine lines, deep wrinkles, and collagen production using Straberi Epistamp needling treatment

Group Type OTHER

Straberi Epistamp Microneedling Treatment

Intervention Type DEVICE

The patient's entire face will be treated with the Straberi Epistamp needling device.

The following settings will be used as a treatment protocol. Needle length between .02- 1.55 mm

No Treatment

Non-Randomized patients who seek improvement for elastin, fine lines, deep wrinkles, and collagen production.

Group Type OTHER

Straberi Epistamp Microneedling Treatment

Intervention Type DEVICE

The patient's entire face will be treated with the Straberi Epistamp needling device.

The following settings will be used as a treatment protocol. Needle length between .02- 1.55 mm

Interventions

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Straberi Epistamp Microneedling Treatment

The patient's entire face will be treated with the Straberi Epistamp needling device.

The following settings will be used as a treatment protocol. Needle length between .02- 1.55 mm

Intervention Type DEVICE

Other Intervention Names

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Needling

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Lavish Beauty

UNKNOWN

Sponsor Role collaborator

Universal Skincare Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maurice Wright, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University/ Harlem Hospital

Leslie L Nesbitt

Role: STUDY_CHAIR

Universal Skincare

Locations

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Lavish

New York, New York, United States

Site Status

Countries

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United States

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.

Reference Type BACKGROUND
PMID: 17199653 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8033378 (View on PubMed)

Related Links

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Other Identifiers

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1116

Identifier Type: -

Identifier Source: org_study_id