NCT07815132Completed
Fractional CO₂ Laser for Primary Cutaneous Amyloidosis
Clinical and Ultrastructural Evaluation of Fractional CO₂ Laser in the Treatment of Primary Cutaneous Amyloidosis: A Randomized, Controlled Clinical Study
Source: ClinicalTrials.gov · Last updated 11 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 22 (actual)
- First submitted
- 6 Sept 2026
- Start date
- 10 Sept 2024
- Primary completion date
- 24 Jun 2025
- Lead sponsor
- Tanta University
- Diseases
- Amyloidosis
- NCT number
- NCT07815132
What you commit to
- Study type: Interventional
- Participants enrolled: 22
- From 10 Sept 2024 to the primary completion date, 24 Jun 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tanta University Hospitals Coordinator of this site? Confirm its status | Tanta | Egypt | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.