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Completed

NCT Number: NCT04740268

Straberi Microneedling For Atrophic Acne

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

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Key information

Conditions

Atrophic Acne Scar

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lavish Beauty

New York, 10028, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other names: microneedling

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Universal Skincare Institute

Other

Collaborators

  • Lavish Beauty

Registry information

Official study title

Clinical Trial Study for the Use of Straberi Microneedling Device to Treat Atrophic Acne Scarring

Acronym: SAA

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 5, 2021
Registry last updated
Dec 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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