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Ablative Fractional Laser for Sclerotic GVHD-Associated Joint Contractures

Primary Purpose

Subjects With Severe, Refractory Sclerotic Skin Changes

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

CO2 Laser

Ultrasound

Skin Biopsy

About this trial

This is an interventional supportive care trial for Subjects With Severe, Refractory Sclerotic Skin Changes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Abramson Cancer Center of the University of Pennsylvania

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

rAblative Fractional Laser for Sclerotic GVHD-Associated Joint

Arm Description

Range of motion limitations and joint contractures due to sclerotic GVHD across a specific joint / limb"

Outcomes

Primary Outcome Measures

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).

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.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT02881047

First Posted

August 24, 2016

Last Updated

April 6, 2020

Sponsor

Abramson Cancer Center at Penn Medicine

1. Study Identification

Unique Protocol Identification Number

NCT02881047

Brief Title

Ablative Fractional Laser for Sclerotic GVHD-Associated Joint Contractures

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Terminated

Study Start Date

November 11, 2013 (Actual)

Primary Completion Date

August 2016 (Actual)

Study Completion Date

August 19, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Abramson Cancer Center at Penn Medicine

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Subjects With Severe, Refractory Sclerotic Skin Changes

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Allocation

N/A

Enrollment

8 (Actual)

8. Arms, Groups, and Interventions

Arm Title

rAblative Fractional Laser for Sclerotic GVHD-Associated Joint

Arm Type

Experimental

Arm Description

Range of motion limitations and joint contractures due to sclerotic GVHD across a specific joint / limb"

Intervention Type

Device

Intervention Name(s)

CO2 Laser

Intervention Description

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.

Intervention Type

Radiation

Intervention Name(s)

Ultrasound

Intervention Description

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

Intervention Type

Diagnostic Test

Intervention Name(s)

Skin Biopsy

Intervention Description

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

Primary Outcome Measure Information:

Title

Number of Subjects Who Show Improvement in Range of Motion, Flexion, and Extension

Description

Range of motion (flexion, extension, supination, pronation) of the target joint (measured in degrees, using a goniometer).

Time Frame

5 months from time point zero / baseline

Title

Number of Subjects With Evidence of Collagen Remodeling (Increased Dermal Echogenicity) Compared to Baseline

Description

Measurement of skin echogencity (brightness) in comparison with pre-therapy images of the same areas using high-resolution ultrasound.

Time Frame

3 months after final laser session (5 months after time zero / baseline)

Title

Number of Subjects Who Show Decrease in Skin Thickness and Sclerosis With Collagen Remodeling as Measured by Before and After Skin Biopsies Biopsy

Description

Trichcrome stain, collagen fiber number and thickness, Herovici stain, elastic fiber length, and dermal thickness.

Time Frame

baseline and 3 months after final laser session

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Robert Micheletti, MD

Organizational Affiliation

Abramson Cancer Center at Penn Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Abramson Cancer Center of the University of Pennsylvania

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

12. IPD Sharing Statement

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Ablative Fractional Laser for Sclerotic GVHD-Associated Joint Contractures

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