Laser Treatment for the Improvement of Scars and Scleroderma (NCT04567537) | Clinical Trial Compass
TerminatedNot Applicable
Laser Treatment for the Improvement of Scars and Scleroderma
Stopped: Recruitment has been slow and we are prioritizing other studies.
United States6 participantsStarted 2021-06-02
Plain-language summary
In this study, the investigators seek to evaluate the effects of a laser treatment on the redistribution/regeneration of collagen on the clinical, microscopic, and molecular profiles of hypertrophic scars and scleroderma.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Subject must be able and willing to provide written informed consent and comply with the requirements of the study protocol;
✓. In good general health, based on answers provided during the screening visit;
✓. Subject must be able to read and understand English;
✓. Any gender and any Fitzpatrick skin type;
✓. Age equal to or greater than 18 years old;
✓. Subjects in the hypertrophic scar branch must have at least one extragenital hypertrophic scar (defined as abnormal proliferation of scar tissue that forms at the site of cutaneous injury and does not regress and grows beyond the original margins of the scar) large enough to treat for both the control and experimental arm (at least 4cm in length for spit scar treatment) or two similar hypertrophic scars (at least 4cm2 for each);
✓. Subjects in the scleroderma branch must have eligible extragenital lesions; large enough to treat for both the control and experimental arm or two similar scleroderma areas (at least 4cm2 area for each);
Exclusion criteria
✕. Participation in another investigational drug or device clinical trial in the past 30 days;
✕. Are pregnant or lactating;
✕. Use of any prescription or in-clinic medications or treatments, such as intralesional corticosteroids or excision, on the eligible scars/scleroderma in the previous 3 months;
What they're measuring
1
Change in Vancouver Scar Scale Score Post-Treatment
. History of allergic reaction to topical or local anesthesia;
✕. Regular intake of high doses of anti-inflammatory drugs (aspirin \>81 mg/day, ibuprofen, corticosteroids, etc.) or immunosuppressive drugs;
✕. Clinically significant abnormal findings or conditions which might, in the opinion of the Investigator, interfere with study evaluations or pose a risk to subject safety during the study.