Ablative Fractional Laser for Sclerotic GVHD-Associated Joint Contractures

NCT ID: NCT02881047

Last Updated: 2020-04-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-11
• Study Completion Date: 2016-08-19

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE

Study Groups

rAblative Fractional Laser for Sclerotic GVHD-Associated Joint

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

Group Type: EXPERIMENTAL

CO2 Laser

Intervention Type: 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.

Ultrasound

Intervention Type: RADIATION

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

Skin Biopsy

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

CO2 Laser

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: DEVICE

Ultrasound

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

Intervention Type: RADIATION

Skin Biopsy

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

Intervention Type: DIAGNOSTIC_TEST

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abramson Cancer Center at Penn Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Micheletti, MD

Role: PRINCIPAL_INVESTIGATOR

Abramson Cancer Center at Penn Medicine

Locations

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

UPCC 14613

Identifier Type: -

Identifier Source: org_study_id