Ablative Fractional Laser for Sclerotic GVHD-Associated Joint Contractures

Stopped early · Not applicable

Conditions studied: Subjects With Severe, Refractory Sclerotic Skin Changes

In brief

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.

Key facts

Study ID

NCT02881047

Run by

Abramson Cancer Center at Penn Medicine

People needed

8

Starts

2013-11-11

Expected to finish

2016-08-19

Last updated by the study team

2020-04-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

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

Full record on ClinicalTrials.gov

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