Striae Distensae Treatment Using Deep Skin Abrasion

NCT ID: NCT07087405

Last Updated: 2025-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-01

Study Completion Date

2026-12-01

Brief Summary

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The goal of this clinical trial is to learn if a device works to treat striae distensae. It will also learn about the safety of the device. The main questions it aims to answer are:

1. Does the device improve the appearance of striae distensae?
2. Does the device cause any problems when treating striae distensae? Researchers will compare the appearance of striae distensae before and after treatment with the device.

Participants will:

1. Undergo treatment with the device in the clinic
2. Visit the clinic 1 week, 3 months, and 1 year for checkups and tests

Detailed Description

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Participants will have the area of striae distensae anesthetized with local anesthetic. A biopsy will be performed and a device will be placed underneath the skin that will abrade the skin. Three months later another biopsy will be performed, photographs will be taken, and participants will fill out surveys to determine the effectiveness of the device to improve the appearance of the striae distensae.

Conditions

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Striae Distensae

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Striae Distensae Treatment

Striae Distensae Treatment With A Device

Group Type EXPERIMENTAL

Striae Distensae Treatment Device

Intervention Type DEVICE

One time deep skin treatment

Interventions

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Striae Distensae Treatment Device

One time deep skin treatment

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Striae distensae

Exclusion Criteria

* Smoking, coagulation deficiency
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Arin Greene

Professor of Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Arin Greene, MD

Role: PRINCIPAL_INVESTIGATOR

Boston Children's Hospital

Central Contacts

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Arin Greene, MD

Role: CONTACT

16173552306

Patrick Smits, PhD

Role: CONTACT

6173552306

Other Identifiers

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IRB-P00051021

Identifier Type: -

Identifier Source: org_study_id

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