CalcitoninPhase 3NCT07655804
Subcutaneous Calcitonin in Acute Herpes Zoster
A Phase 3 study testing Calcitonin and Saline in people with Calcitonin and Subcutaneous, run by Tanta University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Calcitonin, Subcutaneous, Acute Herpes Zoster
- What is being tested?
- Calcitonin and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 168 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2026to 1 Oct 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients aged ≥ 50 years, with acute herpes zoster infection (rash duration < 7 days) and moderate to severe pain.
Who cannot join
- Coagulation abnormalities
- Pre-existing other pain syndrome or psychological disorders.
- Severe hepatic, cardiovascular, or renal disorders.
- Allergy to calcitonin.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Tanta University Hospitals
Tanta, Gharbia Governorate, 31527
Amira M Elkeblawy, MD, 01148529429 ext. 002, marmoramero999@gmail.com
About this study
Official title: The Prophylactic Value of Subcutaneous Calcitonin in Acute Herpes Zoster Patients: A Randomized Controlled Trial
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.
Read the detailed description
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.
- Conditions
- Calcitonin, Subcutaneous, Acute Herpes Zoster
- Being tested
- Calcitonin, Saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CalcitoninDrug
patients will receive subcutaneous salmon calcitonin 100 IU (ampoule = 1 ml) daily for three weeks
SalineOther
patients will receive subcutaneous saline (1 ml) daily for three weeks.
| Study group | Role | What they receive |
|---|---|---|
| Calcitonin group | Experimental | patients will receive subcutaneous salmon calcitonin 100 IU (ampoule = 1 ml) daily for three weeks. Receives: Drug: Calcitonin |
| Control group | Placebo comparator | patients will receive subcutaneous saline (1 ml) daily for three weeks. Receives: Other: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months after onset of acute herpes zoster rash.
Secondary outcomes (4)
Incidence of postherpetic neuralgia.
Pain score more than 3.
Measured: 6 months after onset of acute herpes zoster rash.
Severity of acute herpes zoster pain.
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.
Measured: Up to 1 month after onset of acute herpes zoster rash.
Number of medications used to treat pain.
Analgesics, anti-neuropathic pain medications and opioids will be recorded.
Measured: up to 6 months after onset of acute herpes zoster rash.
Side effects
Vomiting
Measured: Up to 1 month after onset of acute herpes zoster rash.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2026
- Study start1 Jul 2026
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CalcitoninStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel assignment
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 168 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Elkabalawy, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07655804
- Sponsor's protocol ID
- 36265PR14/4/26
- Status last verified
- Jul 2026
- First submitted
- 13 Jun 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prophylactic Value of Subcutaneous Calcitonin in Acute Herpes Zoster Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07655804
- Acronym / sponsor ID
- 36265PR14/4/26
- Conditions
- Calcitonin, Subcutaneous, Acute Herpes Zoster
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 18 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel assignment
| Arm | Type | Receives |
|---|---|---|
| Calcitonin group | Experimental | Drug: Calcitoninpatients will receive subcutaneous salmon calcitonin 100 IU (ampoule = 1 ml) daily for three weeks. |
| Control group | Placebo comparator | Other: Salinepatients will receive subcutaneous saline (1 ml) daily for three weeks. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients aged ≥ 50 years, with acute herpes zoster infection (rash duration < 7 days) and moderate to severe pain.
Key exclusion criteria (4 listed)
- Coagulation abnormalities
- Pre-existing other pain syndrome or psychological disorders.
- Severe hepatic, cardiovascular, or renal disorders.
- Allergy to calcitonin.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calcitoninpatients will receive subcutaneous salmon calcitonin 100 IU (ampoule = 1 ml) daily for three weeks | Drug | Calcitonin group |
| Salinepatients will receive subcutaneous saline (1 ml) daily for three weeks. | Other | Control group |
Primary outcome
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.
4 secondary outcomes
Incidence of postherpetic neuralgia.
Time frame: 6 months after onset of acute herpes zoster rash.
Severity of acute herpes zoster pain.
Time frame: Up to 1 month after onset of acute herpes zoster rash.
Number of medications used to treat pain.
Time frame: up to 6 months after onset of acute herpes zoster rash.
Side effects
Time frame: Up to 1 month after onset of acute herpes zoster rash.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Calcitonin and Saline in people with Calcitonin and Subcutaneous, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amira M Elkeblawy, MD (01148529429 ext. 002, marmoramero999@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postherpetic neuralgia at 3 months after rash onset. (time frame: 3 months after onset of acute herpes zoster rash.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.