NCT07087405

Brief 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. 1.Does the device improve the appearance of striae distensae?
  2. 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.
  3. 3.Undergo treatment with the device in the clinic
  4. 4.Visit the clinic 1 week, 3 months, and 1 year for checkups and tests

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
7mo left

Started Oct 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress51%
Oct 2025Dec 2026

First Submitted

Initial submission to the registry

July 20, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 28, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2025

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

July 28, 2025

Status Verified

July 1, 2025

Enrollment Period

1.2 years

First QC Date

July 20, 2025

Last Update Submit

July 20, 2025

Conditions

Striae Distensae

Keywords

Striae Distensae

Outcome Measures

Primary Outcomes (1)

  • Improvement in Striae Distensae Appearance

    Comparison of photographs before and after treatment

    From enrollment to 12 months after treatment

Study Arms (1)

Striae Distensae Treatment

EXPERIMENTAL

Striae Distensae Treatment With A Device

Device: Striae Distensae Treatment Device

Interventions

Striae Distensae Treatment DeviceDEVICE

One time deep skin treatment

Striae Distensae Treatment

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Striae distensae

You may not qualify if:

  • Smoking, coagulation deficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Striae Distensae

Condition Hierarchy (Ancestors)

Skin ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Arin Greene, MD

    Boston Children's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Arin Greene, MD

CONTACT

16173552306arin.greene@childrens.harvard.edu

Patrick Smits, PhD

CONTACT

6173552306patrick.smits@childrens.harvard.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Surgery

Study Record Dates

First Submitted

July 20, 2025

First Posted

July 28, 2025

Study Start

October 1, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

July 28, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

IPD will be aggregated