Striae DistensaeNCT07087405
Striae Distensae Treatment Using Deep Skin Abrasion
A study testing Striae Distensae Treatment Device in people with Striae Distensae, run by Boston Children's Hospital at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Striae Distensae
- What is being tested?
- Striae Distensae Treatment Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2025to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Striae distensae
Who cannot join
- Smoking
- coagulation deficiency
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Boston Children's Hospital
Boston, Massachusetts, 02115
Patrick Smits, patrick.smits@childrens.harvard.edu
About this study
Official title: Stretch Mark Treatment Using Subcutaneous Skin Abrasion
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:
- Does the device improve the appearance of striae distensae?
- 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:
- Undergo treatment with the device in the clinic
- Visit the clinic 1 week, 3 months, and 1 year for checkups and tests
Read the detailed description
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
- Striae Distensae
- Being tested
- Striae Distensae Treatment Device
- Keywords
- Striae Distensae
- Medical subject headings
- Striae Distensae
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Striae Distensae Treatment DeviceDevice
One time deep skin treatment
| Study group | Role | What they receive |
|---|---|---|
| Striae Distensae Treatment | Experimental | Striae Distensae Treatment With A Device Receives: Device: Striae Distensae Treatment Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Striae Distensae Appearance
Comparison of photographs before and after treatment
Measured: From enrollment to 12 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2025
- Study start1 Oct 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Striae DistensaeStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arin Greene, Boston Children's Hospital
- Investigators
- Arin Greene, MD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07087405
- Sponsor's protocol ID
- IRB-P00051021
- Status last verified
- May 2026
- First submitted
- 20 Jul 2025
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will be aggregated
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stretch Mark Treatment Using Subcutaneous Skin Abrasion
- ClinicalTrials.gov ID
- NCT07087405
- Acronym / sponsor ID
- IRB-P00051021
- Conditions
- Striae Distensae
- Keywords
- Striae Distensae
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 28 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does the device improve the appearance of striae distensae?
- 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:
- Undergo treatment with the device in the clinic
- Visit the clinic 1 week, 3 months, and 1 year for checkups and tests
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Striae Distensae Treatment | Experimental | Device: Striae Distensae Treatment DeviceStriae Distensae Treatment With A Device |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Striae distensae
Key exclusion criteria (2 listed)
- Smoking
- coagulation deficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Striae Distensae Treatment DeviceOne time deep skin treatment | Device | Striae Distensae Treatment |
Primary outcome
Improvement in Striae Distensae Appearance
Time frame: From enrollment to 12 months after treatment
Comparison of photographs before and after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Individual participant dataSharing planned: No. IPD will be aggregated
Related trials for Striae Distensae
Not yet recruiting
Evaluating the Effectiveness and Safety of Microneedling With Topical Tranexamic Acid in Treatment of Striae Rubra
Striae Rubra
RecruitingObservational study
Prevention of Stretch Marks in Expectant Mothers
Pregnant Women, Stretch Mark
Not yet recruitingPhase 1
Efficacy Of Combined Microneedling Plus Tretinoin In Treatment Of Stria Rubra
Striae
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Arin Greene, MD principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Striae Distensae Treatment Device in people with Striae Distensae, run by Boston Children's Hospital 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 1 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 28 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Arin Greene, MD (16173552306, arin.greene@childrens.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in Striae Distensae Appearance (time frame: From enrollment to 12 months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 May 2026.