Ablative Fractional Laser for Sclerotic GVHD-Associated Joint Contractures

Ablative Fractional Laser Resurfacing for the Treatment of Scars and Contractures Caused by Sclerotic Skin Changes Chronic Graft Versus Host Disease

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.

Study Overview

• Status: Terminated
• Conditions: Subjects With Severe, Refractory Sclerotic Skin Changes
• Intervention / Treatment: Device: CO2 Laser; Radiation: Ultrasound; Diagnostic test: Skin Biopsy

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Abramson Cancer Center of the University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects must be able to give informed consent
• All adult patients (18 years of age or older) Severe sclerotic skin changes of chronic graft versus host disease meeting a score of 3 on the NIH consensus criteria for organ scoring of chronic GVHD,
• a score defined by deep sclerotic features with hidebound skin which cannot be pinched together, resulting in impaired motion.
• According to the NIH criteria, the patient need not have widespread cutaneous GVHD; hidebound skin OR impaired mobility receive a score of 3 (highest score).
• Demonstrable range of motion limitations and joint contractures due to sclerotic GVHD across a specific joint / limb amenable to laser therapy must be present. - - Patients must note an inability to bend the joint (e.g. foot, wrist, elbow) freely which compromises the ability to perform specific tasks (e.g. walking up or down stairs, grabbing / making a fist, lifting or raising thearms over the head). As these functional limitations are by their nature subjective (and NIH scoring criteria are themselves subjective) determination of eligibility will be made by the investigator.
• ECOG Performance Status shall be 0-3

Exclusion Criteria:

• Persons unable to provide informed consent Pregnant or nursing women, or children under age 18
• Active infections such as herpes simplex virus (HSV) Acute, untreated medical problems such as poorly-controlled diabetes, decompensated heart failure, etc.
• There are no specific contraindications to use of the laser based on skin pigmentation, sun sensitivity, history of keloids, use of specific medications, etc.
• Appropriateness for trial entry will be determined on an individual basis by the study investigators.
• Patients with ECOG Performance Status 3 will be excluded.
• Patients with ANC 1500,PLT 50, or Hgb 8.0 will be excluded.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: rAblative Fractional Laser for Sclerotic GVHD-Associated Joint; Range of motion limitations and joint contractures due to sclerotic GVHD across a specific joint / limb"

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects Who Show Improvement in Range of Motion, Flexion, and Extension	Range of motion (flexion, extension, supination, pronation) of the target joint (measured in degrees, using a goniometer).	5 months from time point zero / baseline
Number of Subjects With Evidence of Collagen Remodeling (Increased Dermal Echogenicity) Compared to Baseline	Measurement of skin echogencity (brightness) in comparison with pre-therapy images of the same areas using high-resolution ultrasound.	3 months after final laser session (5 months after time zero / baseline)
Number of Subjects Who Show Decrease in Skin Thickness and Sclerosis With Collagen Remodeling as Measured by Before and After Skin Biopsies Biopsy	Trichcrome stain, collagen fiber number and thickness, Herovici stain, elastic fiber length, and dermal thickness.	baseline and 3 months after final laser session

Collaborators and Investigators

• Sponsor: Abramson Cancer Center of the University of Pennsylvania
• Investigators: Principal Investigator: Robert Micheletti, MD, Abramson Cancer Center of the University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2013
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): August 19, 2016

Study Registration Dates

• First Submitted: August 24, 2016
• First Submitted That Met QC Criteria: August 24, 2016
• First Posted (Estimate): August 26, 2016

Study Record Updates

• Last Update Posted (Actual): April 16, 2020
• Last Update Submitted That Met QC Criteria: April 6, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Joint Diseases; Musculoskeletal Diseases; Muscular Diseases; Sclerosis; Contracture
• Other Study ID Numbers: UPCC 14613