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NCT Number: NCT07655804

Subcutaneous Calcitonin in Acute Herpes Zoster

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.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Tanta University Hospitals

Tanta, Gharbia Governorate, 31527, Egypt

Location status: Recruiting

Location contact

Amira M Elkeblawy, MD

CONTACT

[email protected]

01148529429 ext. 002

About this study

Herpes zoster is associated with inflammation of the dorsal root ganglion and peripheral nerves, and this inflammation is considered to be an important causative factor for postherpetic neuralgia.

Interventions aimed at reducing this inflammation should therefore be effective in decreasing the likelihood of developing postherpetic neuralgia. Epidural administration of corticosteroids and local anesthetics has been shown to be effective, but is associated with the risk of arachnoiditis. Subcutaneous injection in an outpatient setting may be effective in preventing postherpetic neuralgia and is also considerably safer. Calcitonin has previously been shown to be effective in the management of acute pain following amputation. Also it was used in a previous study to prevent complex regional pain syndrome in severe hemiplegic patients after stroke. Also, a previous case report revealed that IV calcitonin provided immediate and sustained improvement in post herpetic neuralgia for over two months, without adverse effects from the calcitonin therapy.

However, no previous trials evaluated the effect of subcutaneous calcitonin as a preventive measure against the development of postherpetic neuralgia. We will conduct this study as we hypothesize that calcitonin therapy in patients with acute herpes zoster may be associated with better acute pain control and therefore may decrease the incidence of postherpetic neuralgia.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Calcitonin

Drug

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

Saline

Other

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

Primary outcomes

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

    Time frame: 3 months after onset of acute herpes zoster rash.

    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.

Secondary outcomes

  1. Incidence of postherpetic neuralgia.

    Time frame: 6 months after onset of acute herpes zoster rash.

    Pain score more than 3.

  2. Severity of acute herpes zoster pain.

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

    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.

  3. Number of medications used to treat pain.

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

    Analgesics, anti-neuropathic pain medications and opioids will be recorded.

  4. Side effects

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

    Vomiting

Study contacts

Contact information is provided by the study sponsor or research team.

Amira M Elkeblawy, MD

CONTACT

[email protected]

01148529429 ext. 002

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

The Prophylactic Value of Subcutaneous Calcitonin in Acute Herpes Zoster Patients: A Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 18, 2026
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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