Clinical trial NCT04567537: Laser Treatment for the Improvement of Scars and Scleroderma
Official title: Ablative Fractional Laser Treatment for the Improvement of Hypertrophic Scars and Scleroderma: a Prospective Cohort Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Scars
Scleroderma
Keywords: Scar
Scleroderma
Laser
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2020-09-28
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The investigators will be performing a prospective cohort study, where the entire lesion will receive laser treatment.
Primary purpose: TREATMENT

Brief 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.

Detailed description: This study is designed to evaluate the efficacy of laser treatment for the improvement of the clinical appearance of disorders of collagen metabolism, including hypertrophic scars and scleroderma. The investigators will be performing a prospective cohort study. The entire lesion will receive laser treatment only.

The investigators plan to have 20 patients (10 patients with hypertrophic scars and 10 patients with scleroderma) complete the study.

Subjects must be equal to greater than 18 years old, but may be any gender or Fitzpatrick skin type. They must have one of the following: at least one extragenital hypertrophic scar, or at least one extragenital area of scleroderma . Subjects must not have received any prescription or in-clinic medications or treatments, such as intralesional corticosteroids or excision, on the eligible scars/scleroderma in the previous 3 months. Those on anti-inflammatory or immunosuppressive medications will also be excluded.

Eligibility criteria: Inclusion Criteria:

1. Subject must be able and willing to provide written informed consent and comply with the requirements of the study protocol;
2. In good general health, based on answers provided during the screening visit;
3. Subject must be able to read and understand English;
4. Any gender and any Fitzpatrick skin type;
5. Age equal to or greater than 18 years old;
6. 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);
7. 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:

1. Participation in another investigational drug or device clinical trial in the past 30 days;
2. Are pregnant or lactating;
3. 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;
4. History of allergic reaction to topical or local anesthesia;
5. Regular intake of high doses of anti-inflammatory drugs (aspirin \>81 mg/day, ibuprofen, corticosteroids, etc.) or immunosuppressive drugs;
6. 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.

Primary outcomes:
measure: Physician's Global Assessment Scale
timeFrame: baseline, pre-intervention
measure: Physician's Global Assessment Scale
timeFrame: 1 month after baseline
measure: Physician's Global Assessment Scale
timeFrame: 2 months after baseline
measure: Physician's Global Assessment Scale
timeFrame: 3 months after baseline
measure: Physician's Global Assessment Scale
timeFrame: 4 months after baseline
measure: Physician's Global Assessment Scale
timeFrame: Up to 1 year after baseline
Secondary outcomes:
measure: Mouth Handicap in Systemic Sclerosis scale
timeFrame: Compare baseline to post-procedural
measure: Vancouver Scar Scale
timeFrame: Compare baseline to post-procedural
measure: Range of Motion Evaluation
timeFrame: Compare baseline to post-procedural
Other outcomes:
Locations:
city: Boston
country: United States
facility: MGH Clinical Unit for Research Trials & Outcomes in Skin
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Dieter Manstein, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: