Subcutaneous Calcitonin in Acute Herpes Zoster

NCT07655804 | Recruiting Phase 3

• 1 other identifier: 36265PR14/4/26
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective randomized controlled study will be conducted to evaluate the effect of adding calcitonin to the standard treatment protocol in patients with acute herpes zoster infection.

Conditions

Acute Herpes Zoster; Calcitonin; Subcutaneous

Outcome Measures

Primary Outcomes (1)

• Incidence of postherpetic neuralgia at 3 months after rash onset.

  A numeric rating scale (NRS) that ranged from 0 for "no pain" to 10 for "worst ever pain will be used to assess the degree of pain. Pain score more than (3) at 3 months after onset of acute herpes zoster rash will be considered positive for the occurrence of postherpetic neuralgia.

  3 months after onset of acute herpes zoster rash.

Secondary Outcomes (4)

• Incidence of postherpetic neuralgia.

  6 months after onset of acute herpes zoster rash.

• Severity of acute herpes zoster pain.

  Up to 1 month after onset of acute herpes zoster rash.

• Number of medications used to treat pain.

  up to 6 months after onset of acute herpes zoster rash.

• Side effects

  Up to 1 month after onset of acute herpes zoster rash.

Study Arms (2)

Calcitonin group

EXPERIMENTAL

patients will receive subcutaneous salmon calcitonin 100 IU (ampoule = 1 ml) daily for three weeks.

Drug: Calcitonin

Control group

PLACEBO COMPARATOR

patients will receive subcutaneous saline (1 ml) daily for three weeks.

Other: Saline

Interventions

Calcitonin DRUG

patients will receive subcutaneous salmon calcitonin 100 IU (ampoule = 1 ml) daily for three weeks

Calcitonin group

Saline OTHER

patients will receive subcutaneous saline (1 ml) daily for three weeks.

Control group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients aged ≥ 50 years, with acute herpes zoster infection (rash duration \< 7 days) and moderate to severe pain.

You may not qualify if:

• Coagulation abnormalities
• Pre-existing other pain syndrome or psychological disorders.
• Severe hepatic, cardiovascular, or renal disorders.
• Allergy to calcitonin.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University Hospitals

Tanta, Gharbia Governorate, 31527, Egypt

RECRUITING

MeSH Terms

Interventions

Calcitonin; Sodium Chloride

Intervention Hierarchy (Ancestors)

Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Thyroid Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

Amira M Elkeblawy, MD

CONTACT

01148529429; marmoramero999@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double blind
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor of anesthesiology, surgical intensive care and pain medicine Tanta university

Model Details: Parallel assignment

Study Record Dates

• First Submitted: June 13, 2026
• First Posted: June 18, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: July 6, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: After completion of the study.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)