We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Straberi Microneedling For Atrophic Acne (SAA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04740268
Recruitment Status : Recruiting
First Posted : February 5, 2021
Last Update Posted : October 31, 2022
Sponsor:
Collaborator:
Lavish Beauty
Information provided by (Responsible Party):
Universal Skincare Institute

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

Condition or disease Intervention/treatment Phase
Atrophic Acne Scar Device: Straberi Not Applicable

Detailed Description:
This pilot study will expand the knowledge and application of needling using the Straberi microneedling device and its safety and benefits for improving the appearance of atrophic acne scarring. The pilot aims to objectively measure skin quality using the Derma Scan, photographs, and provide objective data showing improvement by way of the Goodman and Barons quantitative scar scale.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Participants in the Straberi microneedling trial are those who are seeking improvement for atrophic acne scaring.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Trial Study for the Use of Straberi Microneedling Device to Treat Atrophic Acne Scarring
Estimated Study Start Date : November 21, 2022
Estimated Primary Completion Date : May 30, 2023
Estimated Study Completion Date : June 2, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne Scars

Arm Intervention/treatment
Patiant without treatment
Non-Randomized patients with atrophic acne skin conditions
Device: Straberi

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

Other Name: microneedling

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

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

Other Name: microneedling




Primary Outcome Measures :
  1. Overall Patient satisfaction of skin improvement assessed by the Goodman and Barons quantitative scar scale. [ Time Frame: 6 months ]
    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.

  2. The Global Aesthetic Improvement Scale (GAIS) [ Time Frame: 6 months ]
    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


Secondary Outcome Measures :
  1. Overall Skin changes assessed by Derma Scan [ Time Frame: 6 months ]
    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

  2. Overall Skin changes assessed by Acne Scar Subtypes [ Time Frame: 6 months ]
    Skin improvement assessed by Acne Scar Subtypes for improvement of acne scarring rolling, icepick, and or boxcar subtypes.Ice pick scars are narrow, sharply demarcated, V-shaped tracts, <2 mm in diameter, that extend into the deep dermis or even subcutaneous layer. Boxcar scars are wider (1-4 mm in diameter), U-shaped tracts, with sharp, vertical edges that extend 0.1-0.5 mm into the dermis. Rolling scars are characterised by dermal tethering of the dermis to the subcutis. They are generally ≥4 mm in diameter, irregular, with a rolling or undulating appearance.Scale will be completed at every office visit over the 6 month study.

  3. Photographs [ Time Frame: 6 months ]
    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).

  4. To evaluate the impact on the quality of life (DLQI) [ Time Frame: 6 months ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04740268


Contacts
Layout table for location contacts
Contact: Steven Wong, Tech 6468384154 trials@universalskincareinstitute.com
Contact: Michelle Jenkins, Tech 6468384154

Locations
Layout table for location information
United States, New York
Lavish Beauty Recruiting
New York, New York, United States, 10028
Contact: Leslie Nesbitt, Tech    646-838-4154    trials@universalskincareinstitute.com   
Contact: Steven Wong, MD         
Sponsors and Collaborators
Universal Skincare Institute
Lavish Beauty
Investigators
Layout table for investigator information
Principal Investigator: Maurice E Wright, DR Columbia University/ Harlem Hospital HHCNYC
Study Chair: Leslie L Nesbitt Universal Skincare
Additional Information:
Publications of Results:
Other Publications:
Layout table for additonal information
Responsible Party: Universal Skincare Institute
ClinicalTrials.gov Identifier: NCT04740268    
Other Study ID Numbers: 1114
First Posted: February 5, 2021    Key Record Dates
Last Update Posted: October 31, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Once the overall trial is completed and sensitive detailed information is legally advised to published.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Universal Skincare Institute:
microneedling
atrophic acne
epistamp
universal skincare institute
Additional relevant MeSH terms:
Layout table for MeSH terms
Atrophy
Pathological Conditions, Anatomical