Trial Outcomes & Findings for Ablative Fractional Laser for Sclerotic GVHD-Associated Joint Contractures (NCT NCT02881047)

NCT ID: NCT02881047

Last Updated: 2020-04-16

Results Overview

Range of motion (flexion, extension, supination, pronation) of the target joint (measured in degrees, using a goniometer).

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 8 participants
• Primary outcome timeframe: 5 months from time point zero / baseline
• Results posted on: 2020-04-16

Participant Flow

Participant milestones

Measure	rAblative Fractional Laser for Sclerotic GVHD-Associated Joint Range of motion limitations and joint contractures due to sclerotic GVHD across a specific joint / limb" 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. Ultrasound: Patients will undergo ultrasound of the planned treatment site to measure skin thickness and blood flow via Doppler ultrasound. Skin Biopsy: standard 4mm punch biopsy of the skin at the planned treatment site for histologic assessment of skin thickness and sclerosis. Photography: Photography of the affected area / intended treatment area.
Overall Study STARTED	8
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	rAblative Fractional Laser for Sclerotic GVHD-Associated Joint Range of motion limitations and joint contractures due to sclerotic GVHD across a specific joint / limb" 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. Ultrasound: Patients will undergo ultrasound of the planned treatment site to measure skin thickness and blood flow via Doppler ultrasound. Skin Biopsy: standard 4mm punch biopsy of the skin at the planned treatment site for histologic assessment of skin thickness and sclerosis. Photography: Photography of the affected area / intended treatment area.
Overall Study Adverse Event	1
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Ablative Fractional Laser for Sclerotic GVHD-Associated Joint Contractures

Baseline characteristics by cohort

Measure	rAblative Fractional Laser for Sclerotic GVHD-Associated Joint n=8 Participants Range of motion limitations and joint contractures due to sclerotic GVHD across a specific joint / limb" 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. Ultrasound: Patients will undergo ultrasound of the planned treatment site to measure skin thickness and blood flow via Doppler ultrasound. Skin Biopsy: standard 4mm punch biopsy of the skin at the planned treatment site for histologic assessment of skin thickness and sclerosis. Photography: Photography of the affected area / intended treatment area.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	8 Participants n=5 Participants

PRIMARY outcome

Timeframe: 5 months from time point zero / baseline

Range of motion (flexion, extension, supination, pronation) of the target joint (measured in degrees, using a goniometer).

Outcome measures

Measure

rAblative Fractional Laser for Sclerotic GVHD-Associated Joint n=6 Participants Range of motion limitations and joint contractures due to sclerotic GVHD across a specific joint / limb" 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. Ultrasound: Patients will undergo ultrasound of the planned treatment site to measure skin thickness and blood flow via Doppler ultrasound. Skin Biopsy: standard 4mm punch biopsy of the skin at the planned treatment site for histologic assessment of skin thickness and sclerosis. Photography: Photography of the affected area / intended treatment area.

Number of Subjects Who Show Improvement in Range of Motion, Flexion, and Extension

6 Participants

PRIMARY outcome

Timeframe: 3 months after final laser session (5 months after time zero / baseline)

Measurement of skin echogencity (brightness) in comparison with pre-therapy images of the same areas using high-resolution ultrasound.

Outcome measures

Measure

rAblative Fractional Laser for Sclerotic GVHD-Associated Joint n=6 Participants Range of motion limitations and joint contractures due to sclerotic GVHD across a specific joint / limb" 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. Ultrasound: Patients will undergo ultrasound of the planned treatment site to measure skin thickness and blood flow via Doppler ultrasound. Skin Biopsy: standard 4mm punch biopsy of the skin at the planned treatment site for histologic assessment of skin thickness and sclerosis. Photography: Photography of the affected area / intended treatment area.

Number of Subjects With Evidence of Collagen Remodeling (Increased Dermal Echogenicity) Compared to Baseline

6 Participants

PRIMARY outcome

Timeframe: baseline and 3 months after final laser session

Trichcrome stain, collagen fiber number and thickness, Herovici stain, elastic fiber length, and dermal thickness.

Outcome measures

Measure

rAblative Fractional Laser for Sclerotic GVHD-Associated Joint n=6 Participants Range of motion limitations and joint contractures due to sclerotic GVHD across a specific joint / limb" 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. Ultrasound: Patients will undergo ultrasound of the planned treatment site to measure skin thickness and blood flow via Doppler ultrasound. Skin Biopsy: standard 4mm punch biopsy of the skin at the planned treatment site for histologic assessment of skin thickness and sclerosis. Photography: Photography of the affected area / intended treatment area.

Number of Subjects Who Show Decrease in Skin Thickness and Sclerosis With Collagen Remodeling as Measured by Before and After Skin Biopsies Biopsy

6 Participants

Adverse Events

rAblative Fractional Laser for Sclerotic GVHD-Associated Joint

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	rAblative Fractional Laser for Sclerotic GVHD-Associated Joint n=8 participants at risk Range of motion limitations and joint contractures due to sclerotic GVHD across a specific joint / limb" 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. Ultrasound: Patients will undergo ultrasound of the planned treatment site to measure skin thickness and blood flow via Doppler ultrasound. Skin Biopsy: standard 4mm punch biopsy of the skin at the planned treatment site for histologic assessment of skin thickness and sclerosis. Photography: Photography of the affected area / intended treatment area.
Cardiac disorders Left Brachial artery clot	12.5% 1/8 • Number of events 1 • 8 months
Infections and infestations Biopsy site infection	12.5% 1/8 • Number of events 1 • 8 months

Other adverse events

Measure

rAblative Fractional Laser for Sclerotic GVHD-Associated Joint n=8 participants at risk Range of motion limitations and joint contractures due to sclerotic GVHD across a specific joint / limb" 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. Ultrasound: Patients will undergo ultrasound of the planned treatment site to measure skin thickness and blood flow via Doppler ultrasound. Skin Biopsy: standard 4mm punch biopsy of the skin at the planned treatment site for histologic assessment of skin thickness and sclerosis. Photography: Photography of the affected area / intended treatment area.

Nervous system disorders Pain at Treatment site (right foot)

12.5% 1/8 • Number of events 1 • 8 months

Additional Information

Study Coordinator

Hospital of the University of Pennsylvania

Phone: 215-662-6722

Email: leahyd@uphs.upenn.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place