Postherpetic Neuralgia ( PHN )
Conditions
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.
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
Sponsors
Zagazig University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Open-label study; participants and investigators are not masked to treatment assignment.
Intervention model description
Participants will be assigned to one of three parallel groups: intradermal exosome injection, intradermal autologous platelet-rich plasma injection, or intradermal triamcinolone acetonide injection.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Pain Severity Using the Visual Analog Scale | Baseline and final treatment session, approximately 6 weeks after baseline |
Secondary
| Measure | Time frame |
|---|---|
| Change in Neuropathic Pain Scale Score | Baseline, final treatment session, 3 months after last session, and 6 months after last session |
Countries
Egypt
Contacts
CONTACTmona Elradi
Outcome results
None listed