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Ablative Fractional Laser for Sclerotic GVHD-Associated Joint Contractures

NCT02881047 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2020-04-16

Study results available
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Summary

Graft versus host disease (GVHD) is a common complication of allogeneic stem cell transplant.Chronic GVHD is characterized by skin thickening and tightening. Advanced sclerosis can lead to reduced range of motion and incapacitating joint contractures. Once present, there are few therapeutic options. We will treat sclerosis and limb contractures with an ablative fractional laser, a device FDA-approved for scar treatment. This approach has successfully treated contracturesdue to burn scars.

Conditions

  • Subjects With Severe, Refractory Sclerotic Skin Changes

Interventions

DEVICE

CO2 Laser

Perform ablative fractional resurfacing using a 10,600nm carbon dioxide (CO2) laser targeted to thickened, sclerotic plaques causing range of motion limitation and contracture across joints.

RADIATION

Ultrasound

Patients will undergo ultrasound of the planned treatment site to measure skin thickness and blood flow via Doppler ultrasound.

DIAGNOSTIC_TEST

Skin Biopsy

standard 4mm punch biopsy of the skin at the planned treatment site for histologic assessment of skin thickness and sclerosis.

Sponsors & Collaborators

  • Abramson Cancer Center at Penn Medicine

    lead OTHER

Principal Investigators

  • Robert Micheletti, MD · Abramson Cancer Center at Penn Medicine

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-11
Primary Completion
2016-08-31
Completion
2016-08-19

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02881047 on ClinicalTrials.gov