Microneedling Alone vs Microneedling With PRP in the Treatment of Macular Amyloidosis; a Split Face Comparative Study

January 17, 2026 updated by: Amira Elbendary, Cairo University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria: • Both genders were included.

  • 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).
  • Immunocompromised patients (HIV, chemotherapy).
  • Patients with history of any type of autoimmune disorders, coagulopathies, and keloid tendency.
  • Known or suspected allergy to ingredients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: microneedling
microneedling will be done on the first arm
Device: microneedling
microneedling will be done for the one arm of macular amyloidosis
Active Comparator: macular amyloidosis treated with microneedling and PRP
Device: microneedling with PRP
microneedling with PRP will be done on macular amyloidosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 10, 2026

Primary Completion (Estimated)

March 30, 2026

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

December 27, 2025

First Submitted That Met QC Criteria

January 17, 2026

First Posted (Actual)

January 22, 2026

Study Record Updates

Last Update Posted (Actual)

January 22, 2026

Last Update Submitted That Met QC Criteria

January 17, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MS-59-2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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