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Efficacy and Safety of Intravenous Dexamethasone Palmitate Treatments in Acute and Subacute Herpes Zoster Pain

NCT07344246 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 954

Last updated 2026-01-15

No results posted yet for this study

Summary

This is a randomized, prospective, multicenter, open-label, blinded-endpoint study investigating the efficacy and safety of dexamethasone palmitate (DXP) for treating acute and subacute herpes zoster (shingles) pain.

The study consists of four parallel sub-studies, each designed to answer a specific question:

Study 1: Compares intramuscular (IM) vs. intravenous (IV) administration of DXP (8mg) against standard therapy alone.

Study 2: Compares two different IV doses of DXP (4mg vs. 8mg) against standard therapy.

Study 3: For HZ on the body trunk, compares IM injection vs. tender point infiltration vs. paravertebral nerve block (all containing 8mg DXP).

Study 4: For HZ on the face (trigeminal nerve), compares IM injection vs. tender point infiltration vs. trigeminal nerve block (all containing 8mg DXP).

Approximately 558 adult patients with HZ rash onset within 90 days and significant pain (VAS ≥7) will be enrolled across the studies. All patients receive standard background therapy, including antiviral medication (famciclovir), pregabalin, and rescue analgesics.

The primary outcome is the change in pain intensity (Visual Analogue Scale, VAS) over 6 months. Secondary outcomes include the incidence of postherpetic neuralgia (PHN) at 3 and 6 months, consumption of pain medications, patient satisfaction, quality of life, and safety.

The goal is to determine if DXP, through its targeted anti-inflammatory action, provides superior pain relief and PHN prevention compared to standard care, with a favorable safety profile across different administration routes.

Conditions

  • Herpes Zoster Pain

Interventions

DRUG

intramuscular injection (IM group) or intravenous infusion (IV group)

after routine physical examinations and vital sign monitor, they received 8 mg dexamethasone palmitate administered via intramuscular injection (IM group) or intravenous infusion (IV group)

Sponsors & Collaborators

  • Beijing Tiantan Hospital

    lead OTHER

Principal Investigators

  • Fang Luo · Beijing Tiantan Hospital, Capital Medical University,Beijing, China

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-01
Primary Completion
2028-09-01
Completion
2028-12-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07344246 on ClinicalTrials.gov