Ablative Fractional Laser for Sclerotic GVHD-Associated Joint Contractures

NCT02881047 | Terminated Results DMC

• 1 other identifier: UPCC 14613
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Subjects With Severe, Refractory Sclerotic Skin Changes

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

rAblative Fractional Laser for Sclerotic GVHD-Associated Joint

EXPERIMENTAL

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

Device: CO2 Laser; Radiation: Ultrasound; Diagnostic Test: Skin Biopsy

Interventions

CO2 Laser DEVICE

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.

rAblative Fractional Laser for Sclerotic GVHD-Associated Joint

Ultrasound RADIATION

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

rAblative Fractional Laser for Sclerotic GVHD-Associated Joint

Skin Biopsy DIAGNOSTIC_TEST

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

rAblative Fractional Laser for Sclerotic GVHD-Associated Joint

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Interventions

Lasers, Gas; High-Energy Shock Waves

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies; Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Limitations and Caveats

Small number of study subjects.

Results Point of Contact

• Title: Study Coordinator
• Organization: Hospital of the University of Pennsylvania

leahyd@uphs.upenn.edu

215-662-6722

Study Officials

• Robert Micheletti, MD

  Abramson Cancer Center at Penn Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2016
• First Posted: August 26, 2016
• Study Start: November 11, 2013
• Primary Completion: August 1, 2016
• Study Completion: August 19, 2016
• Last Updated: April 16, 2020
• Results First Posted: April 16, 2020

Record last verified: 2020-04

Locations

US (1)