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Completed
NCT07815132
Fractional CO₂ Laser for Primary Cutaneous Amyloidosis
Conditions: Amyloid, Fractional, Laser
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 22
Sponsor: Tanta University
Location: Tanta University Hospitals Tanta
Summary
This randomized, controlled clinical study will evaluate the clinical and ultrastructural effects, efficacy, and safety of fractional CO₂ laser in patients with primary cutaneous amyloidosis. Twenty-two eligible patients will be randomly allocated in a 1:1 ratio to receive either three fractional CO₂ laser sessions at 4-week intervals or no active laser treatment (control group). The primary outcome will be the change in the Amyloidosis Severity Score from baseline to one month after the final laser session, with secondary assessments including dermoscopic findings, transmission electron microscopy findings, pruritus severity, patient satisfaction, and adverse events.
Eligibility Criteria
Inclusion Criteria:
* Patients aged 18 years or older, of either sex. Patients with a clinical and histopathologically confirmed diagnosis of primary cutaneous amyloidosis.
No systemic or topical treatment for primary cutaneous amyloidosis for at least 6 months before enrollment.
Ability and willingness to comply with all study procedures and follow-up visits.
Provision of written informed consent before participation.
Exclusion Criteria:
* Patients with systemic amyloidosis. Patients with a history of keloid formation. Patients with coagulation disorders. Pregnant or lactating women. Patients with other relevant dermatological diseases that may interfere with study assessment.
Patients with Fitzpatrick skin types V or VI. Patients with diabetes mellitus or renal or hepatic disease. Patients with photosensitivity.
Source: ClinicalTrials.gov (NCT07815132). StuddyBuddy aggregates publicly available trial information.