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

NCT07344246 | Not Yet Recruiting DMC

• 1 other identifier: KY2025-440-02
• Study Type: interventional
• Target: 954
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• VAS scores at different follow-up time points.

  VAS scores at week 1, week 2, month 1, month 3, month 6 following the treatments.

  week 1, week 2, month 1, month 3, month 6

Secondary Outcomes (1)

• PHN incidence

  month 3 and month 6

Study Arms (3)

intramuscular injection group (IM group)

EXPERIMENTAL

patients were allocated to receive the same standard antiviral therapy as the control group. Additionally, after routine physical examinations and vital sign monitor, they received 8 mg dexamethasone palmitate administered via intramuscular injection (IM group)

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

intravenous infusion group (IV group)

EXPERIMENTAL

patients were allocated to receive the same standard antiviral therapy as the control group. Additionally, after routine physical examinations and vital sign monitor, they received 8 mg dexamethasone palmitate administered via intravenous infusion

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

control group

NO INTERVENTION

HZ patients with onset of skin lesions within 72 hours received a standard seven-day course antiviral therapy with famciclovir 500 mg three times daily. Besides, they received daily 300 mg pregabalin in divided doses (150 mg/12 hours). Once the patient report mild pain (VAS ≤ 3), the trial for reducing the pregabalin dose was done. If the VAS value increased to more than 3, the patient was returned to the last controllable pregabalin dose. Furthermore, nonsteroidal anti-inflammatory drug celecoxib (200 mg on request, up to two times daily) and tramadol (100 mg on request, up to 400mg daily) will be available for as-needed analgesia, so that a sufficient pain therapy is guaranteed.

Interventions

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

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)

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 1. Patients with onset of HZ rash less than 90 days. 2. HZ affected the trigeminal nerves (ophthalmic/ maxillary/ mandibular nerve). 3. Aged 18 to 75 years (inclusive). 4. Pain intensity ≥ 7 cm on a visual analogue scale (VAS) with 0= 'no pain' to 10='unbearable pain'.
• \. Tender point count \> 4. 6. Agreed to sign the informed consent form.

You may not qualify if:

• Infection at the puncture site.
• Poor general situation unable to be treated.
• A history of abuse of narcotics.
• Non-compliance or inability to complete the self-evaluation questionnaires.
• Pregnancy or lactation.
• Patients using immunosuppressants and those with severe systemic diseases such as hematological malignancies, cancers, or autoimmune disorders.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100071, China

Location

MeSH Terms

Interventions

Injections, Intramuscular; Infusions, Intravenous; Population Groups

Intervention Hierarchy (Ancestors)

Injections; Drug Administration Routes; Drug Therapy; Therapeutics; Administration, Intravenous; Infusions, Parenteral; Demography; Population Characteristics

Study Officials

• Fang Luo

  Beijing Tiantan Hospital, Capital Medical University,Beijing, China

  STUDY CHAIR

Central Study Contacts

Xiangjun Zhou, Dr.

CONTACT

010-59976664; zhouxiangjun963@163.com

Chunmei Zhao, Dr.

CONTACT

13611326978; 13611326978@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Beijing Tiantan Hospital

Study Record Dates

• First Submitted: January 7, 2026
• First Posted: January 15, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: January 15, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The de-identified IPD and supporting documents will become available starting 6 months after the publication of the primary trial results . The data will be accessible for a period of 5 years This timeframe aligns with standard data sharing policies to ensure data are available while the research remains relevant.
• Access Criteria: Who can access the IPD: Qualified researchers with a sound scientific proposal. What data will be accessible: De-identified individual participant data and the study protocol. How to access it: Proposals should be submitted to the corresponding author. Approved requestors will need to sign a data access agreement before gaining access via a secure file-sharing service.

Locations

CN (1)