Skin PruritusHA35-ITCHNCT07580911
Efficacy and Safety of HA35 Gel for Ultra-Rapid Skin Pruritus Relief
A study testing 10% High-Concentration 35 kDa Hyaluronan (HA35) Topical Anti-Pruritic Gel in people with Skin Pruritus and Itch, 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 for ultra-rapid relief of moderate-to-severe skin pruritus from diverse etiologies (eczema, neurodermatitis, insect bites, urticaria, postoperative… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Skin Pruritus, Itch, Eczema Itch
- What is being tested?
- 10% High-Concentration 35 kDa Hyaluronan (HA35) Topical Anti-Pruritic 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
- 20 Jun 2026to 20 Aug 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65 years, male or female
- Moderate-to-severe skin pruritus (NRS ≥6) due to eczema, neurodermatitis, insect bites, urticaria, or postoperative wound itch
- Able to understand and complete NRS assessments independently
- Signed written informed consent
Who cannot join
- Topical corticosteroid/antihistamine use within 2 weeks
- Infected, broken, or exudative skin lesions at the application site
- Known hypersensitivity to hyaluronan or gel components
- Severe systemic disease or immune dysfunction
- Pregnant or lactating women
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 Efficacy and Safety of Topical 10% 35 kDa Hyaluronan (HA35) Gel for Ultra-Rapid Relief of Diverse Etiology Skin Pruritus
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 for ultra-rapid relief of moderate-to-severe skin pruritus from diverse etiologies (eczema, neurodermatitis, insect bites, urticaria, postoperative wound itch). Eligible participants will receive a single topical application of HA35 gel. The primary objective is to assess pruritus relief at 10 seconds, 45 minutes, 8 hours, 12 hours, and 24 hours post-application. Safety and local skin tolerability will be evaluated throughout the observation period. This is a minimal-risk, non-pharmacological, non-invasive intervention.
Read the detailed description
This prospective, single-center, single-arm, open-label pilot clinical study investigates the ultra-rapid antipruritic efficacy and safety of topical 10% high-concentration 35 kDa hyaluronan (HA35) gel for managing moderate-to-severe skin pruritus caused by various conditions including eczema, neurodermatitis, insect bites, urticaria, and postoperative wound pruritus.
Eligible subjects will receive a single topical application of HA35 gel evenly spread over the pruritic skin area. Pruritus intensity will be assessed using a 0-10 Numeric Rating Scale (NRS) at baseline, 10 seconds, 45 minutes, 8 hours, 12 hours, and 24 hours after application. Changes in associated erythema, swelling, and wheals will also be observed.
Local skin irritation, allergic reactions, and adverse events will be monitored continuously for safety assessment.
This is 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
- Skin Pruritus, Itch, Eczema Itch, Neurodermatitis, Insect Bite Itch, Urticaria
- Being tested
- 10% High-Concentration 35 kDa Hyaluronan (HA35) Topical Anti-Pruritic Gel
- Keywords
- Hyaluronan, 35 kDa Hyaluronan, HA35, Topical Gel, Skin Pruritus, Itch Relief, Ultra-Rapid Relief, Anti-Pruritus, Non-Steroidal, Pilot Clinical Study
- Medical subject headings
- Pruritus, Neurodermatitis, Urticaria
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 Anti-Pruritic GelDevice
Also called HA35 Itch Relief Gel, Rapid Itch Relief HA35 Gel
Topical skin gel containing 10% high-concentration 35 kDa hyaluronan fragment. Applied topically to pruritic areas to provide ultra-rapid relief of skin itching and improve associated inflammatory signs.
| Study group | Role | What they receive |
|---|---|---|
| HA35 Topical Gel Intervention Group | Experimental | Participants receive a single topical application of 10% high-concentration 35 kDa HA35 gel to the pruritic skin area. Efficacy on ultra-rapid pruritus relief, duration of effect, and safety will be evaluated. Receives: Device: 10% High-Concentration 35 kDa Hyaluronan (HA35) Topical Anti-Pruritic Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Skin Pruritus NRS Score (0-10)
Change in pruritus intensity measured by 0-10 NRS, 0 = no itching, 10 = worst imaginable itching.
Measured: Baseline to 10 seconds, 45 minutes, 8 hours, 12 hours, and 24 hours after application
Secondary outcomes (5)
Onset time of clinically significant pruritus relief
Measured: Within 10 seconds after application
Duration of pruritus relief
Measured: Up to 24 hours
Change in Skin Erythema Severity (0-10 NRS Score)
Change in skin erythema severity at the application site, assessed using a 0-10 Numeric Rating Scale (NRS), where 0 = no erythema and 10 = maximum redness.
Measured: Baseline to 45 minutes and 24 hours after application
Change in Local Skin Swelling Severity (0-10 NRS Score)
Change in local skin swelling severity at the application site, assessed using a 0-10 Numeric Rating Scale (NRS), where 0 = no swelling and 10 = maximum swelling.
Measured: Baseline to 45 minutes and 24 hours after application
Change in Urticarial Wheal Severity (0-10 NRS Score)
Change in urticarial wheal severity at the application site, assessed using a 0-10 Numeric Rating Scale (NRS), where 0 = no wheals and 10 = maximum wheal size and spread.
Measured: Baseline to 45 minutes and 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 posted12 May 2026
- Study start20 Jun 2026
- Primary completion20 Jul 2026
- Study completion20 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin PruritusStudies 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
- NCT07580911
- Sponsor's protocol ID
- HA35202608
- Acronym
- HA35-ITCH
- Status last verified
- Apr 2026
- First submitted
- 29 Apr 2026
- Last updated
- 22 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 22 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 Efficacy and Safety of Topical 10% 35 kDa Hyaluronan (HA35) Gel for Ultra-Rapid Relief of Diverse Etiology Skin Pruritus
- ClinicalTrials.gov ID
- NCT07580911
- Acronym / sponsor ID
- HA35-ITCH / HA35202608
- Conditions
- Skin Pruritus, Itch, Eczema Itch, Neurodermatitis, Insect Bite Itch, Urticaria
- Keywords
- Hyaluronan, 35 kDa Hyaluronan, HA35, Topical Gel, Skin Pruritus, Itch Relief, Ultra-Rapid Relief, Anti-Pruritus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Nakhia Impex LLCIndustry (pharma, biotech, devices)
- Study start
- 20 Jun 2026 (actual)
- Primary completion
- 20 Jul 2026 (actual)
- Study completion
- 20 Aug 2026 (actual)
- First posted
- 12 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 for ultra-rapid relief of moderate-to-severe skin pruritus from diverse etiologies (eczema, neurodermatitis, insect bites, urticaria, postoperative wound itch). Eligible participants will receive a single topical application of HA35 gel. The primary objective is to assess pruritus relief at 10 seconds, 45 minutes, 8 hours, 12 hours, and 24 hours post-application. Safety and local skin tolerability will be evaluated throughout the observation period. This is a minimal-risk, non-pharmacological, non-invasive intervention.
Detailed description
This prospective, single-center, single-arm, open-label pilot clinical study investigates the ultra-rapid antipruritic efficacy and safety of topical 10% high-concentration 35 kDa hyaluronan (HA35) gel for managing moderate-to-severe skin pruritus caused by various conditions including eczema, neurodermatitis, insect bites, urticaria, and postoperative wound pruritus.
Eligible subjects will receive a single topical application of HA35 gel evenly spread over the pruritic skin area. Pruritus intensity will be assessed using a 0-10 Numeric Rating Scale (NRS) at baseline, 10 seconds, 45 minutes, 8 hours, 12 hours, and 24 hours after application. Changes in associated erythema, swelling, and wheals will also be observed.
Local skin irritation, allergic reactions, and adverse events will be monitored continuously for safety assessment.
This is 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 Anti-Pruritic GelParticipants receive a single topical application of 10% high-concentration 35 kDa HA35 gel to the pruritic skin area. Efficacy on ultra-rapid pruritus relief, duration of effect, and safety will be evaluated. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-65 years, male or female
- Moderate-to-severe skin pruritus (NRS ≥6) due to eczema, neurodermatitis, insect bites, urticaria, or postoperative wound itch
- Able to understand and complete NRS assessments independently
- Signed written informed consent
Key exclusion criteria (5 listed)
- Topical corticosteroid/antihistamine use within 2 weeks
- Infected, broken, or exudative skin lesions at the application site
- Known hypersensitivity to hyaluronan or gel components
- Severe systemic disease or immune dysfunction
- 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 Anti-Pruritic GelAlso: HA35 Itch Relief Gel, Rapid Itch Relief HA35 GelTopical skin gel containing 10% high-concentration 35 kDa hyaluronan fragment. Applied topically to pruritic areas to provide ultra-rapid relief of skin itching and improve associated inflammatory signs. | Device | HA35 Topical Gel Intervention Group |
Primary outcome
Change in Skin Pruritus NRS Score (0-10)
Time frame: Baseline to 10 seconds, 45 minutes, 8 hours, 12 hours, and 24 hours after application
Change in pruritus intensity measured by 0-10 NRS, 0 = no itching, 10 = worst imaginable itching.
5 secondary outcomes
Onset time of clinically significant pruritus relief
Time frame: Within 10 seconds after application
Duration of pruritus relief
Time frame: Up to 24 hours
Change in Skin Erythema Severity (0-10 NRS Score)
Time frame: Baseline to 45 minutes and 24 hours after application
Change in Local Skin Swelling Severity (0-10 NRS Score)
Time frame: Baseline to 45 minutes and 24 hours after application
Change in Urticarial Wheal Severity (0-10 NRS Score)
Time frame: Baseline to 45 minutes and 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 22 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 Anti-Pruritic Gel in people with Skin Pruritus and Itch, 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 4 inclusion and 5 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 22 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 Skin Pruritus NRS Score (0-10) (time frame: Baseline to 10 seconds, 45 minutes, 8 hours, 12 hours, and 24 hours after 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 22 Sep 2026.