RecruitingNot ApplicableNCT07565844

Intradermal Exosomes, Platelet-Rich Plasma, and Steroids for Post-Herpetic Neuralgia

A Comparative Study of Intradermal Injection of Exosomes, Platelet-Rich Plasma and Steroids in the Treatment of Post-Herpetic Neuralgia


Sponsor

Zagazig University

Enrollment

45 participants

Start Date

Feb 2, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This randomized controlled clinical trial will evaluate and compare the efficacy and safety of intradermal injection of exosomes, platelet-rich plasma, and corticosteroid in patients with post-herpetic neuralgia. Forty-five adult patients with dermatomal pain persisting for at least 90 days after herpes zoster will be enrolled from outpatient clinics. Participants will be assigned to one of three groups: intradermal exosome injection, intradermal autologous platelet-rich plasma injection, or intradermal triamcinolone acetonide injection. Each group will receive four treatment sessions every two weeks. Outcomes will include pain severity, neuropathic pain characteristics, quality of life, patient satisfaction, and adverse effects, assessed at baseline, at the final session, and during follow-up visits at 3 and 6 months after the last session.


Eligibility

Min Age: 18 Years

Inclusion Criteria2

  • Patients with post-herpes zoster persistent dermatomal pain consistent with post-herpetic neuralgia for at least 90 days.
  • Male or female patients. Age 18 years or older. Willingness to comply with study procedures and attend follow-up visits. Ability and willingness to provide written informed consent

Exclusion Criteria2

  • History of hypersensitivity to any of the study treatments. Pregnancy. Any type of skin infection involving the affected dermatome. Immunocompromised patients, including patients with cancer or HIV. Patients with bone marrow aplasia. Patients with known bleeding tendency, platelet dysfunction, or thrombocytopenia, defined as platelet count less than 150 × 10⁹/L.
  • Regular use of anticoagulant or antiplatelet drugs.

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Interventions

BIOLOGICALExosomes

Intradermal injection of 0.1 cc exosome product per 1 cm² square into the affected dermatome, every two weeks for four sessions.

BIOLOGICALPRP

Autologous platelet-rich plasma prepared from 10 mL patient blood by centrifugation at 1000 rpm for 10 minutes, injected intradermally at 0.1 cc per 1 cm² square every two weeks for four sessions.

DRUGCorticosteroids

Intradermal triamcinolone acetonide 10 mg/mL, 0.1 mL per 1 cm² square of the affected dermatome, every two weeks for four sessions


Locations(1)

Zagazig University Hospitals

Zagazig, Zagazig, Egypt

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NCT07565844