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NCT Number: NCT07360860

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

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.

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Key information

Conditions

Macular Amyloidosis

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

microneedling

Device

microneedling will be done for the one arm of macular amyloidosis

microneedling with PRP

Device

microneedling with PRP will be done on macular amyloidosis

Primary outcomes

  1. Improvement of macular amyloidosis using microneedling or PRP with microneedling

    Time frame: 3 months

    • 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Amira Elbendary, MD

CONTACT

[email protected]

+201552208664

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 22, 2026
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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