Clinical trial NCT02881047: 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
Overall status: TERMINATED
Phase: NA
Conditions: Subjects With Severe, Refractory Sclerotic Skin Changes
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2016-08-26
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: Number of Subjects Who Show Improvement in Range of Motion, Flexion, and Extension
timeFrame: 5 months from time point zero / baseline
measure: Number of Subjects With Evidence of Collagen Remodeling (Increased Dermal Echogenicity) Compared to Baseline
timeFrame: 3 months after final laser session (5 months after time zero / baseline)
measure: Number of Subjects Who Show Decrease in Skin Thickness and Sclerosis With Collagen Remodeling as Measured by Before and After Skin Biopsies Biopsy
timeFrame: baseline and 3 months after final laser session
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Abramson Cancer Center at Penn Medicine
name: Robert Micheletti, MD
role: PRINCIPAL_INVESTIGATOR
References: