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

NCT07565844 | Recruiting

• 1 other identifier: 984/5-1-2025
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postherpetic Neuralgia ( PHN )

Outcome Measures

Primary Outcomes (1)

• Change in Pain Severity Using the Visual Analog Scale

  Baseline and final treatment session, approximately 6 weeks after baseline

Secondary Outcomes (1)

• Change in Neuropathic Pain Scale Score

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

Study Arms (3)

Exosomes

EXPERIMENTAL

Participants will receive intradermal injections of exosome product into the affected dermatome. The dermatome will be marked and divided into 1 cm² squares, and 0.1 cc will be injected intradermally into each square using an insulin syringe. Treatment will be given every two weeks for a total of four sessions, followed by visits at 3 and 6 months after the last session.

Biological: Exosomes

PRP

EXPERIMENTAL

Participants will receive intradermal injections of autologous platelet-rich plasma into the affected dermatome. Ten mL of blood will be collected under aseptic conditions and centrifuged at 1000 rpm for 10 minutes. The lower 1-2 cc of plasma will be used as platelet-rich plasma concentrate. The affected dermatome will be marked into 1 cm² squares, and 0.1 cc PRP will be injected intradermally into each square. Treatment will be given every two weeks for four sessions, followed by visits at 3 and 6 months after the last session.

Biological: PRP

Corticosteroids

ACTIVE COMPARATOR

Drug: Corticosteroids

Interventions

Exosomes BIOLOGICAL

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

Exosomes

PRP BIOLOGICAL

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.

PRP

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

Corticosteroids

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Zagazig University Hospitals

Zagazig, Zagazig, 44519, Egypt

RECRUITING

MeSH Terms

Conditions

Neuralgia, Postherpetic

Interventions

Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Neuralgia; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Central Study Contacts

mona Elradi

CONTACT

+201067070550; monaelradi@medicine.zu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open-label study; participants and investigators are not masked to treatment assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Model Details: Participants will be assigned to one of three parallel groups: intradermal exosome injection, intradermal autologous platelet-rich plasma injection, or intradermal triamcinolone acetonide injection.

Study Record Dates

• First Submitted: April 27, 2026
• First Posted: May 4, 2026
• Study Start: February 2, 2025
• Primary Completion (Estimated): August 6, 2026
• Study Completion (Estimated): November 11, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)