AmyloidFCO2-PCANCT07815132
Fractional CO₂ Laser for Primary Cutaneous Amyloidosis
A study testing Fractional CO₂ Laser in people with Amyloid and Fractional, run by Tanta University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amyloid, Fractional, Laser
- What is being tested?
- Fractional CO₂ Laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Sep 2024to 10 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Ultrastructural Evaluation of Fractional CO₂ Laser in the Treatment of Primary Cutaneous Amyloidosis: A Randomized, Controlled Clinical Study
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.
Read the detailed description
Primary cutaneous amyloidosis is a localized skin disorder characterized by deposition of amyloid within the skin. Available treatments include topical therapies, phototherapy, systemic medications, and various physical modalities; however, no treatment is considered consistently curative or satisfactory. Fractional CO₂ laser has been proposed as a promising physical treatment because it produces controlled microscopic columns of thermal injury that can ablate amyloid-laden tissue and stimulate dermal remodeling.
This study is a prospective, randomized, parallel-group, controlled clinical trial conducted at the Department of Dermatology and Venereology, Faculty of Medicine, Tanta University, Egypt. A total of 22 patients aged >18 years, of either sex, with clinically and histopathologically confirmed primary cutaneous amyloidosis will be enrolled and randomly assigned in a 1:1 ratio to two groups using a computer-generated randomization table. Allocation concealment will be performed using opaque, sequentially numbered, sealed envelopes.
Participants in the intervention group will receive three sessions of fractional CO₂ laser, with a 4-week interval between sessions and laser power of 12-18 W. Topical anesthetic cream will be applied before treatment, and patients will receive appropriate post-treatment advice. Participants in the control group will receive no active laser treatment during the study period and will be followed for an equivalent duration; supportive measures such as emollients and antihistamines for pruritus may be used when needed.
Clinical assessment will include photography, dermoscopic examination, the Amyloidosis Severity Score, and assessment of pruritus using a visual analogue scale. Skin biopsies will be obtained at baseline and at the final assessment for transmission electron microscopy, including morphometric and image analysis. Adverse events, including redness, swelling, itching, pain, bacterial infection, and bleeding, will also be monitored.
The primary outcome is the change in Amyloidosis Severity Score from baseline to one month after the last laser session, or the corresponding time point in the control group. Secondary outcomes include dermoscopic changes, ultrastructural changes on transmission electron microscopy, change in pruritus severity, patient satisfaction, and treatment-related adverse events.
The expected study duration is approximately six months, from August 2026 to February 2027. Control-group participants will be offered fractional CO₂ laser treatment free of charge after completion of the study follow-up period.
- Conditions
- Amyloid, Fractional, Laser
- Being tested
- Fractional CO₂ Laser
- Keywords
- amyloidosis, fractional co2
- Medical subject headings
- Alzheimer Disease, Amyloidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fractional CO₂ LaserDevice
3 fractional CO₂ laser sessions
| Study group | Role | What they receive |
|---|---|---|
| Fractional CO₂ Laser | Experimental | Fractional CO₂ laser, 3 sessions at 4-week intervals, with power 12-18 W Receives: Device: Fractional CO₂ Laser |
| Control | No intervention | No active laser treatment; supportive care only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 1 month after the last treatment session (Week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2026
- Study start10 Sep 2024
- Primary completion24 Jun 2025
- Study completion10 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmyloidStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Hamdy Soliman, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07815132
- Sponsor's protocol ID
- 36265PR144/7/26
- Acronym
- FCO2-PCA
- Status last verified
- Sep 2026
- First submitted
- 6 Sep 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Ultrastructural Evaluation of Fractional CO₂ Laser in the Treatment of Primary Cutaneous Amyloidosis: A Randomized, Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT07815132
- Acronym / sponsor ID
- FCO2-PCA / 36265PR144/7/26
- Conditions
- Amyloid, Fractional, Laser
- Keywords
- amyloidosis, fractional co2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 10 Sep 2024 (actual)
- Primary completion
- 24 Jun 2025 (actual)
- Study completion
- 10 Aug 2025 (actual)
- First posted
- 11 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Primary cutaneous amyloidosis is a localized skin disorder characterized by deposition of amyloid within the skin. Available treatments include topical therapies, phototherapy, systemic medications, and various physical modalities; however, no treatment is considered consistently curative or satisfactory. Fractional CO₂ laser has been proposed as a promising physical treatment because it produces controlled microscopic columns of thermal injury that can ablate amyloid-laden tissue and stimulate dermal remodeling.
This study is a prospective, randomized, parallel-group, controlled clinical trial conducted at the Department of Dermatology and Venereology, Faculty of Medicine, Tanta University, Egypt. A total of 22 patients aged >18 years, of either sex, with clinically and histopathologically confirmed primary cutaneous amyloidosis will be enrolled and randomly assigned in a 1:1 ratio to two groups using a computer-generated randomization table. Allocation concealment will be performed using opaque, sequentially numbered, sealed envelopes.
Participants in the intervention group will receive three sessions of fractional CO₂ laser, with a 4-week interval between sessions and laser power of 12-18 W. Topical anesthetic cream will be applied before treatment, and patients will receive appropriate post-treatment advice. Participants in the control group will receive no active laser treatment during the study period and will be followed for an equivalent duration; supportive measures such as emollients and antihistamines for pruritus may be used when needed.
Clinical assessment will include photography, dermoscopic examination, the Amyloidosis Severity Score, and assessment of pruritus using a visual analogue scale. Skin biopsies will be obtained at baseline and at the final assessment for transmission electron microscopy, including morphometric and image analysis. Adverse events, including redness, swelling, itching, pain, bacterial infection, and bleeding, will also be monitored.
The primary outcome is the change in Amyloidosis Severity Score from baseline to one month after the last laser session, or the corresponding time point in the control group. Secondary outcomes include dermoscopic changes, ultrastructural changes on transmission electron microscopy, change in pruritus severity, patient satisfaction, and treatment-related adverse events.
The expected study duration is approximately six months, from August 2026 to February 2027. Control-group participants will be offered fractional CO₂ laser treatment free of charge after completion of the study follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fractional CO₂ Laser | Experimental | Device: Fractional CO₂ LaserFractional CO₂ laser, 3 sessions at 4-week intervals, with power 12-18 W |
| Control | No intervention | –No active laser treatment; supportive care only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fractional CO₂ Laser3 fractional CO₂ laser sessions | Device | Fractional CO₂ Laser |
Primary outcome
Amyloidosis Severity Score
Time frame: Baseline to 1 month after the last treatment session (Week 12)
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fractional CO₂ Laser in people with Amyloid and Fractional, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amyloidosis Severity Score (time frame: Baseline to 1 month after the last treatment session (Week 12)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.