10 Participants NeededMy employer runs this trial

Deep Skin Abrasion for Stretch Marks

PS
AG
Overseen ByArin Greene, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Boston Children's Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device, the Striae Distensae Treatment Device, to determine its effectiveness in improving the appearance of stretch marks, or striae distensae, and to assess its safety. Participants will receive treatment for their stretch marks with the device and attend follow-up visits at 1 week, 3 months, and 1 year. This trial suits individuals with stretch marks who do not smoke or have blood clotting issues. As an unphased trial, it provides a unique opportunity for participants to contribute to innovative research and potentially benefit from early access to new treatment options.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this device is safe for treating striae distensae?

Research shows that the device used for treating stretch marks is generally safe. Studies on similar treatments, such as microneedling, have found mild side effects, including temporary skin darkening, redness, and crusting. These effects are expected and usually not serious. Some participants experienced slight pain and observed skin changes that improved over time. Overall, participants tolerated these treatments well, suggesting this device is likely safe too.12345

Why are researchers excited about this trial?

Unlike the standard treatments for stretch marks, which often include topical creams, laser therapy, and microdermabrasion, the Striae Distensae Treatment Device offers a new approach through deep skin abrasion. This technique aims to physically resurface the skin, promoting regeneration at a deeper level than current options. Researchers are excited about this treatment because it potentially offers more significant and faster visible improvements by deeply targeting and remodeling the affected skin layers.

What evidence suggests that this device is effective for treating striae distensae?

Research has shown that treatments for stretch marks, such as the device studied in this trial, can lead to noticeable improvements. Similar devices have demonstrated that 25% of patients see moderate improvement, while 56% experience good results. These treatments promote the skin's natural healing, which can gradually fade stretch marks. Other options, like CO2 lasers and certain creams, have also successfully reduced stretch marks. However, results can vary depending on factors such as the age of the stretch marks and skin type. Overall, this treatment device appears promising based on these findings.12356

Who Is on the Research Team?

AG

Arin Greene, MD

Principal Investigator

Boston Children's Hospital

Are You a Good Fit for This Trial?

This trial is for people who have stretch marks (striae distensae) and want to try a new device treatment. Participants must have visible stretch marks but there are no other major restrictions listed.

Inclusion Criteria

I have stretch marks on my skin.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo treatment with the device in the clinic, including local anesthesia and biopsy

1 day
1 visit (in-person)

Follow-up

Participants visit the clinic for checkups and tests to monitor safety and effectiveness

12 months
3 visits (in-person) at 1 week, 3 months, and 1 year

What Are the Treatments Tested in This Trial?

Interventions

  • Striae Distensae Treatment Device

Trial Overview

The study tests a deep skin abrasion device designed to improve the appearance of stretch marks. All participants receive the treatment in a clinic, with follow-up visits at 1 week, 3 months, and 1 year.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Striae Distensae TreatmentExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Boston Children's Hospital

Lead Sponsor

Trials
801
Recruited
5,584,000+

Citations

Striae Distensae Treatment Review and Update - PMC

This article reviews all currently accepted modalities and their effectiveness in the treatment of stretch marks.

A Systematic Review on Treatment Outcomes of Striae

The highest rates of complete response were injection-based devices for striae distensae (7%; n 5 12/172), CO2 lasers for striae alba (4%; n 5 12/341), and ...

Stretch Marks: Systematic Review of its Therapeutic ...

Tretinoin at 0.1% and glycolic acid at different concentrations demonstrated clinical improvement, especially in recent stretch marks.

Striae Distensae (Stretch Marks) Treatment & Management

Significant improvement in the appearance of the stretch marks was observed 2 months after treatment. Histologic examination revealed a ...

Striae distensae: What's new at the horizon?

Only one study was conducted, which concluded that the product markedly lowered the incidence of stretch mark development after pregnancy.40 Glycolic acid 10- ...

Medline ® Abstracts for References 75-81 of 'Striae ...

CONCLUSION The clinical results obtained in this study support the safe and effective treatment of striae distensae with microneedling in light and dark ...