Ablative Fractional Laser for Sclerotic GVHD-Associated Joint Contractures

Not Applicable

Terminated

• Conditions: Subjects With Severe, Refractory Sclerotic Skin Changes
• Interventions: Device: CO2 Laser; Radiation: Ultrasound; Diagnostic Test: Skin Biopsy

• Registration Number: NCT02881047
• Lead Sponsor: Abramson Cancer Center at Penn Medicine

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11-11
• Primary Completion: 2016-08
• Study Completion: 2016-08-19
• Study First Submitted: 2016-08-24
• Study First Submitted QC: 2016-08-24
• Study First Posted: 2016-08-26
• Results First Submitted: 2019-04-10
• Status Verified: 2020-04
• Results First Submitted QC: 2020-04-06
• Last Update Submitted: 2020-04-06
• Results First Posted: 2020-04-16
• Last Update Posted: 2020-04-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
rAblative Fractional Laser for Sclerotic GVHD-Associated Joint	CO2 Laser	Range of motion limitations and joint contractures due to sclerotic GVHD across a specific joint / limb"
rAblative Fractional Laser for Sclerotic GVHD-Associated Joint	Ultrasound	Range of motion limitations and joint contractures due to sclerotic GVHD across a specific joint / limb"
rAblative Fractional Laser for Sclerotic GVHD-Associated Joint	Skin Biopsy	Range of motion limitations and joint contractures due to sclerotic GVHD across a specific joint / limb"

Primary Outcome Measures

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

Trial Locations

Locations (1)

Abramson Cancer Center of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States