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Atrophic Acne ScarSAANCT04740268

Straberi Microneedling For Atrophic Acne

A study testing Straberi in people with Atrophic Acne Scar, run by Universal Skincare Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 21 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Atrophic Acne Scar
What is being tested?
Straberi
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteUnited States
Study dates
23 Dec 2022to 12 Oct 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 24Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Lavish Beauty

    New York, New York, 10028

Other trials in United States

About this study

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

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

Read the 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.

Being tested
Straberi
Keywords
microneedling, atrophic acne, epistamp, universal skincare institute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • StraberiDevice

    Also called microneedling

    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

Study groups in NCT04740268
Study groupRoleWhat they receive
Patiant without treatmentOtherNon-Randomized patients with atrophic acne skin conditions
Receives: Device: Straberi
Straberi Microneedling TreatmentOtherNon-Randomized treatment for patients with atrophic acne skin conditions using the Straberi Microneedling device.
Receives: Device: Straberi

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 6 months

  2. 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

    Measured: 6 months

Secondary outcomes (4)

  1. Overall Skin changes 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

    Measured: 6 months

  2. Overall Skin changes assessed by Acne Scar Subtypes

    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.

    Measured: 6 months

  3. 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).

    Measured: 6 months

  4. 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.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Feb 2021
  2. Study start23 Dec 2022
  3. Primary completion30 Jun 2023
  4. Study completion12 Oct 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Model description
Participants in the Straberi microneedling trial are those who are seeking improvement for atrophic acne scaring.
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04740268
Sponsor's protocol ID
1114
Acronym
SAA
Status last verified
Jan 2023
First submitted
13 Sep 2020
Last updated
6 Dec 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Undecided: Once the overall trial is completed and sensitive detailed information is legally advised to published.

Publications

  • 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.

    PubMed 8033378

  • 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.

    PubMed 17199653

Questions about this trial

What is this clinical trial studying?

A study testing Straberi in people with Atrophic Acne Scar, run by Universal Skincare Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Patient satisfaction of skin improvement assessed by the Goodman and Barons quantitative scar scale. (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04740268, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2023.

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