Macular AmyloidosisNCT07360860
Microneedling Alone vs Microneedling With PRP in the Treatment of Macular Amyloidosis; a Split Face Comparative Study
A study testing microneedling and microneedling with PRP in people with Macular Amyloidosis, run by Cairo University.
Trial summary
This study is going to asses and compare the efficacy of treatment of macular amyloidosis using microneedling vs PRP with microneedling. Pruritus and pigmentation will be assessed. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Macular Amyloidosis
- What is being tested?
- microneedling and microneedling with PRP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 10 Jan 2026to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients above 18 years old.
- Patients diagnosed by macular amyloidosis, proved by dermoscopy and histopathology.
- Exclusion Criteria: • Prior use of topical therapies in the previous 4 weeks.
- Prior use of any procedures such as chemical peel or laser treatment in the previous 1 month.
- Prior use of any systemic treatment for macular amyloidosis in the past 12 weeks.
- Patients with other skin conditions (e.g., psoriasis, eczema).
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- Immunocompromised patients (HIV, chemotherapy).
- Patients with history of any type of autoimmune disorders, coagulopathies, and keloid tendency.
- Known or suspected allergy to ingredients
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparison Between Efficacy and Safety of PRP With Microneedling and Microneedling Alone in Treatment of Macular Amyloidosis; a Split Face Blinded Non Randomized Control Trial With Dermoscopic and Histopathologic Evaluation
This study is going to asses and compare the efficacy of treatment of macular amyloidosis using microneedling vs PRP with microneedling. Pruritus and pigmentation will be assessed.
- Conditions
- Macular Amyloidosis
- Being tested
- microneedling, microneedling with PRP
- Keywords
- Macular amyloidosis, Microneedling, PRP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
microneedlingDevice
microneedling will be done for the one arm of macular amyloidosis
microneedling with PRPDevice
microneedling with PRP will be done on macular amyloidosis
| Study group | Role | What they receive |
|---|---|---|
| microneedling | Active comparator | microneedling will be done on the first arm Receives: Device: microneedling |
| macular amyloidosis treated with microneedling and PRP | Active comparator | Not described Receives: Device: microneedling with PRP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of macular amyloidosis using microneedling or PRP with microneedling
- The clinical assessment will be performed based on the photographs taken at baseline, after 1month, and 3 months of the last session.
- Results will be measured by the Quartile grading scale:
1< 25% improvement 2=25-<50% improvement 3=50-<75% improvement 4> 75% improvement 3. Degree of improvement in dermoscopic features will be measured by scoring system as follows : 0-25% = 0 (no improvement) 26-50% = 1(mild improvement) 51-75% = 2 (moderate improvement) 76- 100% = 3 (marked improvement) 4. Patients' satisfaction: Visual Analog Score for pain 5.measuring the Treatment Satisfaction Questionnaire for Medication (TSQM) for effectiveness.
- TPhysician global satisfaction will be assessed. 0-3 (unsatisfied) 4-6 (satisfied) 7-10 (highly satisfied)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start10 Jan 2026 (estimated)
- Primary completion30 Mar 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular AmyloidosisStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Face split
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Elbendary, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07360860
- Sponsor's protocol ID
- MS-59-2025
- Status last verified
- Jan 2026
- First submitted
- 27 Dec 2025
- Last updated
- 22 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Efficacy and Safety of PRP With Microneedling and Microneedling Alone in Treatment of Macular Amyloidosis; a Split Face Blinded Non Randomized Control Trial With Dermoscopic and Histopathologic Evaluation
- ClinicalTrials.gov ID
- NCT07360860
- Acronym / sponsor ID
- MS-59-2025
- Conditions
- Macular Amyloidosis
- Keywords
- Macular amyloidosis, Microneedling, PRP
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Jan 2026 (estimated)
- Primary completion
- 30 Mar 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 22 Jan 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 study is going to asses and compare the efficacy of treatment of macular amyloidosis using microneedling vs PRP with microneedling. Pruritus and pigmentation will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Face split
| Arm | Type | Receives |
|---|---|---|
| microneedling | Active comparator | Device: microneedlingmicroneedling will be done on the first arm |
| macular amyloidosis treated with microneedling and PRP | Active comparator | Device: microneedling with PRP |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients above 18 years old.
- Patients diagnosed by macular amyloidosis, proved by dermoscopy and histopathology.
- Exclusion Criteria: • Prior use of topical therapies in the previous 4 weeks.
- Prior use of any procedures such as chemical peel or laser treatment in the previous 1 month.
- Prior use of any systemic treatment for macular amyloidosis in the past 12 weeks.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| microneedlingmicroneedling will be done for the one arm of macular amyloidosis | Device | microneedling |
| microneedling with PRPmicroneedling with PRP will be done on macular amyloidosis | Device | macular amyloidosis treated with microneedling and PRP |
Primary outcome
Improvement of macular amyloidosis using microneedling or PRP with microneedling
Time frame: 3 months
1. The clinical assessment will be performed based on the photographs taken at baseline, after 1month, and 3 months of the last session. 2. Results will be measured by the Quartile grading scale: 1< 25% improvement 2=25-<50% improvement 3=50-<75% improvement 4> 75% improvement 3. Degree of improvement in dermoscopic features will be measured by scoring system as follows : 0-25% = 0 (no improvement) 26-50% = 1(mild improvement) 51-75% = 2 (moderate improvement) 76- 100% = 3 (marked improvement) 4. Patients' satisfaction: Visual Analog Score for pain 5.measuring the Treatment Satisfaction Questionnaire for Medication (TSQM) for effectiveness. 6. TPhysician global satisfaction will be assessed. 0-3 (unsatisfied) 4-6 (satisfied) 7-10 (highly satisfied)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing microneedling and microneedling with PRP in people with Macular Amyloidosis, run by Cairo University.
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 9 inclusion and 0 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: opening soon, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amira Elbendary, MD (+201552208664, aelbendary@kasralainy.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of macular amyloidosis using microneedling or PRP with microneedling (time frame: 3 months). 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 22 Jan 2026.