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

NCT07360860 | Not Yet Recruiting

• 1 other identifier: MS-59-2025
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Macular Amyloidosis

Keywords

Macular amyloidosis; Microneedling; PRP

Outcome Measures

Primary Outcomes (1)

• Improvement of macular amyloidosis using microneedling or PRP with microneedling

  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

Study Arms (2)

microneedling

ACTIVE COMPARATOR

microneedling will be done on the first arm

Device: microneedling

macular amyloidosis treated with microneedling and PRP

ACTIVE COMPARATOR

Device: microneedling with PRP

Interventions

microneedling DEVICE

microneedling will be done for the one arm of macular amyloidosis

microneedling

microneedling with PRP DEVICE

microneedling with PRP will be done on macular amyloidosis

macular amyloidosis treated with microneedling and PRP

Eligibility Criteria

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

You may qualify if:

• Patients above 18 years old.
• Patients diagnosed by macular amyloidosis, proved by dermoscopy and histopathology.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Interventions

Percutaneous Collagen Induction

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Punctures; Rehabilitation

Central Study Contacts

Amira Elbendary, MD

CONTACT

+201552208664; aelbendary@kasralainy.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer in Cairo University

Model Details: Face split

Study Record Dates

• First Submitted: December 27, 2025
• First Posted: January 22, 2026
• Study Start: January 10, 2026
• Primary Completion: March 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share