Subjects With Severe, Refractory Sclerotic Skin ChangesNCT02881047
Ablative Fractional Laser for Sclerotic GVHD-Associated Joint Contractures
A study testing CO2 Laser, Ultrasound and Skin Biopsy in people with Subjects With Severe, Refractory Sclerotic Skin Changes, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subjects With Severe, Refractory Sclerotic Skin Changes
- What is being tested?
- CO2 Laser, Ultrasound and Skin Biopsy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Nov 2013to 19 Aug 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Ablative Fractional Laser Resurfacing for the Treatment of Scars and Contractures Caused by Sclerotic Skin Changes Chronic Graft Versus Host Disease
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.
- Being tested
- CO2 Laser, Ultrasound, Skin Biopsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CO2 LaserDevice
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.
UltrasoundRadiation
Patients will undergo ultrasound of the planned treatment site to measure skin thickness and blood flow via Doppler ultrasound.
Skin BiopsyDiagnostic test
standard 4mm punch biopsy of the skin at the planned treatment site for histologic assessment of skin thickness and sclerosis.
| Study group | Role | What they receive |
|---|---|---|
| rAblative Fractional Laser for Sclerotic GVHD-Associated Joint | Experimental | Range of motion limitations and joint contractures due to sclerotic GVHD across a specific joint / limb" Receives: Device: CO2 Laser; Radiation: Ultrasound; Diagnostic Test: Skin Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: baseline and 3 months after final laser session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2016 (estimated)
- Study start11 Nov 2013
- Primary completionAug 2016
- Study completion19 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Subjects With Severe, Refractory Sclerotic Skin ChangesStudies of the same condition, open and under way.
- More trials run by Abramson Cancer Center at Penn MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Micheletti, MD, Principal investigator, Abramson Cancer Center at Penn Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02881047
- Sponsor's protocol ID
- UPCC 14613
- Status last verified
- Apr 2020
- First submitted
- 24 Aug 2016
- Last updated
- 16 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ablative Fractional Laser Resurfacing for the Treatment of Scars and Contractures Caused by Sclerotic Skin Changes Chronic Graft Versus Host Disease
- ClinicalTrials.gov ID
- NCT02881047
- Acronym / sponsor ID
- UPCC 14613
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- 11 Nov 2013 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- 19 Aug 2016 (actual)
- First posted
- 26 Aug 2016 (estimated)
- Results
- Posted 16 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| rAblative Fractional Laser for Sclerotic GVHD-Associated Joint | Experimental | Device: CO2 Laser, Radiation: Ultrasound, Diagnostic Test: Skin BiopsyRange of motion limitations and joint contractures due to sclerotic GVHD across a specific joint / limb" |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CO2 LaserPerform 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. | Device | rAblative Fractional Laser for Sclerotic GVHD-Associated Joint |
| UltrasoundPatients will undergo ultrasound of the planned treatment site to measure skin thickness and blood flow via Doppler ultrasound. | Radiation | rAblative Fractional Laser for Sclerotic GVHD-Associated Joint |
| Skin Biopsystandard 4mm punch biopsy of the skin at the planned treatment site for histologic assessment of skin thickness and sclerosis. | Diagnostic test | rAblative Fractional Laser for Sclerotic GVHD-Associated Joint |
Primary outcome
Number of Subjects Who Show Improvement in Range of Motion, Flexion, and Extension
Time frame: 5 months from time point zero / baseline
Range of motion (flexion, extension, supination, pronation) of the target joint (measured in degrees, using a goniometer).
Number of Subjects With Evidence of Collagen Remodeling (Increased Dermal Echogenicity) Compared to Baseline
Time frame: 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.
Number of Subjects Who Show Decrease in Skin Thickness and Sclerosis With Collagen Remodeling as Measured by Before and After Skin Biopsies Biopsy
Time frame: baseline and 3 months after final laser session
Trichcrome stain, collagen fiber number and thickness, Herovici stain, elastic fiber length, and dermal thickness.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Micheletti, MD principal investigator
Abramson Cancer Center at Penn Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CO2 Laser, Ultrasound and Skin Biopsy in people with Subjects With Severe, Refractory Sclerotic Skin Changes, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects Who Show Improvement in Range of Motion, Flexion, and Extension (time frame: 5 months from time point zero / baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2020.