Herpes ZosterHA35-HZNCT07569978
Efficacy and Safety of High-Concentration 35 kDa Hyaluronan Gel for Herpes Zoster-Associated Pain
A study testing 10% High-Concentration 35 kDa Hyaluronan (HA35) Topical Analgesic Gel in people with Herpes Zoster and Zoster-Associated Pain, run by Nakhia Impex LLC at 1 site in China.
Trial summary
This is a prospective, single-arm, open-label, pilot clinical study to evaluate the efficacy and safety of topical 10% high-concentration 35 kDa hyaluronan (HA35) gel in subjects with herpes zoster-associated pain (ZAP). Eligible participants will receive a single topical application of the study gel. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Herpes Zoster, Zoster-Associated Pain, Postherpetic Neuralgia
- What is being tested?
- 10% High-Concentration 35 kDa Hyaluronan (HA35) Topical Analgesic Gel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2026to 10 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-85 years, male or female
- Clinically diagnosed with herpes zoster-associated pain (acute ZAP or PHN)
- Baseline pain NRS score ≥5
- Ability to understand and complete NRS assessments
- Signed written informed consent
Who cannot join
- Acute bacterial skin infection at the application site
- Use of topical analgesics or antiviral therapy within 24 hours
- Systemic analgesic use within 6 hours
- Known hypersensitivity to hyaluronan or gel components
- Pregnant or lactating women
- Severe systemic disease or malignant tumor
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Single-Arm, Open-Label Pilot Clinical Study to Evaluate the Efficacy and Safety of Topical 10% High-Concentration 35 kDa Hyaluronan (HA35) Gel in Subjects With Herpes Zoster-Associated Pain
This is a prospective, single-arm, open-label, pilot clinical study to evaluate the efficacy and safety of topical 10% high-concentration 35 kDa hyaluronan (HA35) gel in subjects with herpes zoster-associated pain (ZAP). Eligible participants will receive a single topical application of the study gel. The primary objective is to assess rapid pain reduction within 2 minutes and 24hours after application. Secondary objectives include evaluation of analgesic duration, local tolerability, erythema improvement, and overall safety throughout the observation period. This is a minimal-risk, non-pharmacological supportive care intervention.
Read the detailed description
This prospective, single-center, single-arm, open-label pilot clinical study investigates the analgesic efficacy and safety of topical 10% high-concentration 35 kDa hyaluronan (HA35) gel for the management of herpes zoster-associated pain (ZAP), including acute zoster pain and postherpetic neuralgia (PHN).
Eligible subjects will receive a single topical application of HA35 gel to the affected skin area. Pain intensity will be evaluated using a 0-10 Numeric Rating Scale (NRS) at baseline, 2 minutes, 20 minutes, 4 hours, 8 hours, 12 hours, and 24 hours after application.
Local skin reactions, erythema, swelling, and all adverse events will be monitored for safety assessment.
This study uses a non-invasive, non-pharmacological topical intervention with minimal risk to participants. All procedures will be conducted in accordance with the Declaration of Helsinki, and written informed consent will be obtained from all subjects prior to enrollment.
- Conditions
- Herpes Zoster, Zoster-Associated Pain, Postherpetic Neuralgia, Neuropathic Pain, Acute Pain
- Being tested
- 10% High-Concentration 35 kDa Hyaluronan (HA35) Topical Analgesic Gel
- Keywords
- Hyaluronan, 35 kDa Hyaluronan, HA35, Topical Gel, Herpes Zoster, Zoster Pain, Postherpetic Neuralgia, Neuropathic Pain, Analgesia, Non-pharmacological Intervention, Pilot Clinical Study
- Medical subject headings
- Herpes Zoster, Neuralgia, Postherpetic, Neuralgia, Acute Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10% High-Concentration 35 kDa Hyaluronan (HA35) Topical Analgesic GelDevice
Also called HA35 Zoster Pain Gel, HA35 Analgesic Gel
A topical, non-pharmacological gel containing 10% high-concentration 35 kDa hyaluronan fragment. It is applied topically to the affected skin area to relieve herpes zoster-associated pain, reduce inflammation, and improve local tolerability.
| Study group | Role | What they receive |
|---|---|---|
| HA35 Topical Gel Intervention Group | Experimental | Participants will receive a single topical application of 10% high-concentration 35 kDa hyaluronan (HA35 gel) to the affected skin area. Pain intensity, analgesic onset, duration, and local safety will be evaluated. Receives: Device: 10% High-Concentration 35 kDa Hyaluronan (HA35) Topical Analgesic Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Intensity NRS Score (0-10)
Change in zoster-associated pain intensity measured by 0-10 Numeric Rating Scale (NRS), 0 = no pain, 10 = worst imaginable pain.
Measured: Baseline to 2 minutes, 20 minutes, 4 hours, 8 hours, 12 hours, and 24 hours after single topical application
Secondary outcomes (1)
Analgesic Duration
Measured: Up to 24 hours after application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start1 May 2026
- Primary completion10 Jun 2026
- Study completion10 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Herpes ZosterStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nakhia Impex LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07569978
- Sponsor's protocol ID
- HA35202602
- Acronym
- HA35-HZ
- Status last verified
- Apr 2026
- First submitted
- 28 Apr 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-Arm, Open-Label Pilot Clinical Study to Evaluate the Efficacy and Safety of Topical 10% High-Concentration 35 kDa Hyaluronan (HA35) Gel in Subjects With Herpes Zoster-Associated Pain
- ClinicalTrials.gov ID
- NCT07569978
- Acronym / sponsor ID
- HA35-HZ / HA35202602
- Conditions
- Herpes Zoster, Zoster-Associated Pain, Postherpetic Neuralgia, Neuropathic Pain, Acute Pain
- Keywords
- Hyaluronan, 35 kDa Hyaluronan, HA35, Topical Gel, Herpes Zoster, Zoster Pain, Postherpetic Neuralgia, Neuropathic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Nakhia Impex LLCIndustry (pharma, biotech, devices)
- Study start
- 1 May 2026 (actual)
- Primary completion
- 10 Jun 2026 (actual)
- Study completion
- 10 Jul 2026 (actual)
- First posted
- 6 May 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 is a prospective, single-arm, open-label, pilot clinical study to evaluate the efficacy and safety of topical 10% high-concentration 35 kDa hyaluronan (HA35) gel in subjects with herpes zoster-associated pain (ZAP). Eligible participants will receive a single topical application of the study gel. The primary objective is to assess rapid pain reduction within 2 minutes and 24hours after application. Secondary objectives include evaluation of analgesic duration, local tolerability, erythema improvement, and overall safety throughout the observation period. This is a minimal-risk, non-pharmacological supportive care intervention.
Detailed description
This prospective, single-center, single-arm, open-label pilot clinical study investigates the analgesic efficacy and safety of topical 10% high-concentration 35 kDa hyaluronan (HA35) gel for the management of herpes zoster-associated pain (ZAP), including acute zoster pain and postherpetic neuralgia (PHN).
Eligible subjects will receive a single topical application of HA35 gel to the affected skin area. Pain intensity will be evaluated using a 0-10 Numeric Rating Scale (NRS) at baseline, 2 minutes, 20 minutes, 4 hours, 8 hours, 12 hours, and 24 hours after application.
Local skin reactions, erythema, swelling, and all adverse events will be monitored for safety assessment.
This study uses a non-invasive, non-pharmacological topical intervention with minimal risk to participants. All procedures will be conducted in accordance with the Declaration of Helsinki, and written informed consent will be obtained from all subjects prior to enrollment.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HA35 Topical Gel Intervention Group | Experimental | Device: 10% High-Concentration 35 kDa Hyaluronan (HA35) Topical Analgesic GelParticipants will receive a single topical application of 10% high-concentration 35 kDa hyaluronan (HA35 gel) to the affected skin area. Pain intensity, analgesic onset, duration, and local safety will be evaluated. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-85 years, male or female
- Clinically diagnosed with herpes zoster-associated pain (acute ZAP or PHN)
- Baseline pain NRS score ≥5
- Ability to understand and complete NRS assessments
- Signed written informed consent
Key exclusion criteria (6 listed)
- Acute bacterial skin infection at the application site
- Use of topical analgesics or antiviral therapy within 24 hours
- Systemic analgesic use within 6 hours
- Known hypersensitivity to hyaluronan or gel components
- Pregnant or lactating women
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 |
|---|---|---|
| 10% High-Concentration 35 kDa Hyaluronan (HA35) Topical Analgesic GelAlso: HA35 Zoster Pain Gel, HA35 Analgesic GelA topical, non-pharmacological gel containing 10% high-concentration 35 kDa hyaluronan fragment. It is applied topically to the affected skin area to relieve herpes zoster-associated pain, reduce inflammation, and improve local tolerability. | Device | HA35 Topical Gel Intervention Group |
Primary outcome
Change in Pain Intensity NRS Score (0-10)
Time frame: Baseline to 2 minutes, 20 minutes, 4 hours, 8 hours, 12 hours, and 24 hours after single topical application
Change in zoster-associated pain intensity measured by 0-10 Numeric Rating Scale (NRS), 0 = no pain, 10 = worst imaginable pain.
1 secondary outcome
Analgesic Duration
Time frame: Up to 24 hours after application
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 10% High-Concentration 35 kDa Hyaluronan (HA35) Topical Analgesic Gel in people with Herpes Zoster and Zoster-Associated Pain, run by Nakhia Impex LLC at 1 site in China.
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 5 inclusion and 6 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: finished, as of the sponsor's last update on 23 Sep 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 China. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Intensity NRS Score (0-10) (time frame: Baseline to 2 minutes, 20 minutes, 4 hours, 8 hours, 12 hours, and 24 hours after single topical application). 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 23 Sep 2026.