Fractional CO₂ Laser for Primary Cutaneous Amyloidosis

NCT07815132 | Completed DMC

• 1 other identifier: 36265PR144/7/26
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Amyloid; Fractional; Laser

Keywords

amyloidosis; fractional co2

Outcome Measures

Primary Outcomes (1)

• Amyloidosis Severity Score

  Change in the Amyloidosis Severity Score from baseline to one month after completion of the third fractional CO₂ laser session, compared between the fractional CO₂ laser and control groups.

  Baseline to 1 month after the last treatment session (Week 12)

Study Arms (2)

Fractional CO₂ Laser

EXPERIMENTAL

Fractional CO₂ laser, 3 sessions at 4-week intervals, with power 12-18 W

Device: Fractional CO₂ Laser

Control

NO INTERVENTION

No active laser treatment; supportive care only

Interventions

Fractional CO₂ Laser DEVICE

3 fractional CO₂ laser sessions

Fractional CO₂ Laser

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University Hospitals

Tanta, Egypt

Location

MeSH Terms

Conditions

Alzheimer Disease; Amyloidosis

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Study Record Dates

• First Submitted: September 6, 2026
• First Posted: September 11, 2026
• Study Start: September 10, 2024
• Primary Completion: June 24, 2025
• Study Completion: August 10, 2025
• Last Updated: September 11, 2026

Record last verified: 2026-09

Locations

EG (1)