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Sponsor study identifier
interventional
954
1 country
1
Study Start
September 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
September 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 7, 2026
Actual (reported)January 15, 2026
Actual (reported)September 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
VAS scores at different follow-up time points.
VAS scores at week 1, month 1, month 3, month 6, month 12following the treatments.
week 1, month 1, month 3, month 6,month 12
PHN incidence
month 3 and month 6
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 4 mg dexamethasone palmitate administered via intravenous infusion
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
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)
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Beijing Tiantan Hospital
Beijing, Beijing Municipality, 100071, China
Fang Luo
Beijing Tiantan Hospital, Capital Medical University,Beijing, China
First Submitted
January 7, 2026
First Posted
January 15, 2026
Study Start
September 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
September 1, 2028
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.
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Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
August 26, 2026
Record last verified: 2025-12
De-identified individual participant data that underlie the results reported in this article will be shared following publication. The data will be available with researchers who provide a methodologically sound proposal for use in achieving the goals of the approved proposal. Proposals should be directed to the corresponding author. Data requestors will need to sign a data access agreement to gain access.
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Source: ClinicalTrials.gov.
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