Straberi Microneedling For Atrophic Acne

NCT04740268 | Completed DMC FDA Device

• 1 other identifier: 1114
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot study will expand knowledge and application needling using the Straberi microneedling device for the improvement of Atrophic Acne Scarring

Conditions

Atrophic Acne Scar

Keywords

microneedling; atrophic acne; epistamp; universal skincare institute

Outcome Measures

Primary Outcomes (2)

• Overall Patient satisfaction of skin improvement assessed by the Goodman and Barons quantitative scar scale.

  A global quantitative grading system for assessing the disease load and global severity of disease in a patient with post acne scarring. The Goodman and Baron score considers type of scar, number of scars, and severity of scarring and assigns a grade 1-4 with grade 1 representing mild, macular disease and grade 4 representing severe scarring that is obviously visible at social distances of 50cm, is not easily covered by makeup, and is not able to be flattened by manual stretching of the skin. Lower scores are favorable. Scale will be completed at every office visit over the 6 month study.

  6 months

• 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

  6 months

Secondary Outcomes (4)

• Overall Skin changes assessed by Derma Scan

  6 months

• Overall Skin changes assessed by Acne Scar Subtypes

  6 months

• Photographs

  6 months

• To evaluate the impact on the quality of life (DLQI)

  6 months

Study Arms (2)

Patiant without treatment

OTHER

Non-Randomized patients with atrophic acne skin conditions

Device: Straberi

Straberi Microneedling Treatment

OTHER

Non-Randomized treatment for patients with atrophic acne skin conditions using the Straberi Microneedling device.

Device: Straberi

Interventions

Straberi DEVICE

The patient's entire face will be treated with the Straberi microneedling devise. The following settings will be used as a treatment protocol. Needle length between .02- 1.55 mm

Also known as: microneedling

Patiant without treatment; Straberi Microneedling Treatment

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universal Skincare Institute: lead
• Lavish Beauty: collaborator

Study Sites (1)

Lavish Beauty

New York, New York, 10028, United States

Location

Related 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.

  PMID: 8033378 BACKGROUND

• 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.

  PMID: 17199653 RESULT

Related Links

• Derma Scan
• Atrophic Scars Subtypes

MeSH Terms

Interventions

Percutaneous Collagen Induction

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Punctures; Rehabilitation

Study Officials

• Maurice E Wright, DR

  Columbia University/ Harlem Hospital HHCNYC

  PRINCIPAL INVESTIGATOR

• Leslie L Nesbitt

  Universal Skincare

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants in the Straberi microneedling trial are those who are seeking improvement for atrophic acne scaring.

Study Record Dates

• First Submitted: September 13, 2020
• First Posted: February 5, 2021
• Study Start: December 23, 2022
• Primary Completion: June 30, 2023
• Study Completion: October 12, 2023
• Last Updated: December 6, 2023

Record last verified: 2023-01

Locations

US (1)