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

ConditionPostherpetic Neuralgia ( PHN )

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorZagazig University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with post-herpes zoster persistent dermatomal pain consistent with post-herpetic neuralgia for at least 90 days.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

Exosomes
Biological/Vaccine
Intradermal injection of 0.1 cc exosome product per 1 cm² square into the affected dermatome, every two weeks for four sessions.
PRP
Biological/Vaccine
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.
Corticosteroids
Drug
Intradermal triamcinolone acetonide 10 mg/mL, 0.1 mL per 1 cm² square of the affected dermatome, every two weeks for four sessions

Treatment groups

45 Participants

are divided into 3 treatment groups

Group A: ExosomesExperimental treatment 1 intervention

Group B: PRPExperimental treatment 1 intervention

Group C: CorticosteroidsActive comparator 1 intervention

Trial outcomes

Primary outcomes

Change in Pain Severity Using the Visual Analog Scale

Time frame

Baseline and final treatment session, approximately 6 weeks after baseline

Secondary outcomes

Change in Neuropathic Pain Scale Score

Time frame

Baseline, final treatment session, 3 months after last session, and 6 months after last session

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zagazig University

Lead sponsor

Source ClinicalTrials.gov

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