NCT07580911Completed
Efficacy and Safety of HA35 Gel for Ultra-Rapid Skin Pruritus Relief
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
Source: ClinicalTrials.gov · Last updated 22 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 30 (actual)
- First submitted
- 29 Apr 2026
- Start date
- 20 Jun 2026
- Primary completion date
- 20 Jul 2026
- Lead sponsor
- Nakhia Impex LLC
- Diseases
- Atopic dermatitis (eczema)
- NCT number
- NCT07580911
What you commit to
- Study type: Interventional
- Participants enrolled: 30
- From 20 Jun 2026 to the primary completion date, 20 Jul 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Topical corticosteroid/antihistamine use within 2 weeks
Other illness
- Infected, broken, or exudative skin lesions at the application site
- Known hypersensitivity to hyaluronan or gel components
- Severe systemic disease or immune dysfunction
Other
- Pregnant or lactating women
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Qingdao Hynaut Laboratory Coordinator of this site? Confirm its status | Qingdao | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.