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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 10% High-Concentration 35 kDa Hyaluronan (HA35) Topical Anti-Pruritic Gel | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Skin Pruritus NRS Score (0-10) | Change in pruritus intensity measured by 0-10 NRS, 0 = no itching, 10 = worst imaginable itching. | Baseline to 10 seconds, 45 minutes, 8 hours, 12 hours, and 24 hours after application |
| Measure | Description | Time Frame |
|---|---|---|
| Onset time of clinically significant pruritus relief | Within 10 seconds after application | |
| Duration of pruritus relief | Up to 24 hours | |
| Change in Skin Erythema Severity (0-10 NRS Score) |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D011537 | Pruritus |
| D009450 | Neurodermatitis |
| D014581 | Urticaria |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
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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. |
| 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. | 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. | Baseline to 45 minutes and 24 hours after application |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003872 | Dermatitis |
| D017443 | Skin Diseases, Eczematous |
| D017445 | Skin Diseases, Vascular |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |