An interventional study of CO2 Laser and Ultrasound in Subjects With Severe, Refractory Sclerotic Skin Changes, sponsored by Abramson Cancer Center at Penn Medicine. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-04-16.
Sponsored by Abramson Cancer Center at Penn Medicine · Not applicable, Interventional, and Supportive care
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.
151 studies on the registry are indexed under Contracture; 21 are open to participants now.
This study's enrollment of 8 is below the median of 40 across 110 interventional studies indexed under Contracture.
Browse Contracture studies →Abramson Cancer Center at Penn Medicine is the lead sponsor of 446 studies on the registry; 86 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 14 (44%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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.
Patients will undergo ultrasound of the planned treatment site to measure skin thickness and blood flow via Doppler ultrasound.
standard 4mm punch biopsy of the skin at the planned treatment site for histologic assessment of skin thickness and sclerosis.
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).
Time frame: 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.
Time frame: 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.
Time frame: baseline and 3 months after final laser session
| Milestone | rAblative Fractional Laser for Sclerotic GVHD-Associated Joint |
|---|---|
| Started | 8 |
| Completed | 6 |
| Not completed | 2 |
| Withdrew: Adverse event | 1 |
| Withdrew: Withdrawal by subject | 1 |
Range of motion (flexion, extension, supination, pronation) of the target joint (measured in degrees, using a goniometer).
| Participants | rAblative Fractional Laser for Sclerotic GVHD-Associated Joint |
|---|---|
| Number of Subjects Who Show Improvement in Range of Motion, Flexion, and Extension | 6 |
Measurement of skin echogencity (brightness) in comparison with pre-therapy images of the same areas using high-resolution ultrasound.
| Participants | rAblative Fractional Laser for Sclerotic GVHD-Associated Joint |
|---|---|
| Number of Subjects With Evidence of Collagen Remodeling (Increased Dermal Echogenicity) Compared to Baseline | 6 |
Trichcrome stain, collagen fiber number and thickness, Herovici stain, elastic fiber length, and dermal thickness.
| Participants | rAblative Fractional Laser for Sclerotic GVHD-Associated Joint |
|---|---|
| Number of Subjects Who Show Decrease in Skin Thickness and Sclerosis With Collagen Remodeling as Measured by Before and After Skin Biopsies Biopsy | 6 |
Collected over 8 months. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| rAblative Fractional Laser for Sclerotic GVHD-Associated Joint | 0/8 (0%) | 1/8 (12.5%) | 1/8 (12.5%) |
| Event | rAblative Fractional Laser for Sclerotic GVHD-Associated Joint |
|---|---|
| Left Brachial artery clotCardiac disorders | 1/8 |
| Biopsy site infectionInfections and infestations | 1/8 |
| Event | rAblative Fractional Laser for Sclerotic GVHD-Associated Joint |
|---|---|
| Pain at Treatment site (right foot)Nervous system disorders | 1/8 |
| Age, Categorical(Participants) | rAblative Fractional Laser for Sclerotic GVHD-Associated Joint |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 8 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | rAblative Fractional Laser for Sclerotic GVHD-Associated Joint |
|---|---|
| Female | 2 |
| Male | 6 |
| Race (NIH/OMB)(Participants) | rAblative Fractional Laser for Sclerotic GVHD-Associated Joint |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 8 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | rAblative Fractional Laser for Sclerotic GVHD-Associated Joint |
|---|---|
| United States | 8 |
This study is terminated, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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Abramson Cancer Center at Penn Medicine