Efficacy and Safety of HA35 Gel for Ultra-Rapid Skin Pruritus Relief (HA35-ITCH)
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
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: HA35 Topical Gel Intervention Group
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.
|
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.
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Skin Pruritus NRS Score (0-10)
Tidsramme: 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.
|
Baseline to 10 seconds, 45 minutes, 8 hours, 12 hours, and 24 hours after application
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Onset time of clinically significant pruritus relief
Tidsramme: Within 10 seconds after application
|
Within 10 seconds after application
|
|
|
Duration of pruritus relief
Tidsramme: Up to 24 hours
|
Up to 24 hours
|
|
|
Change in Skin Erythema Severity (0-10 NRS Score)
Tidsramme: Baseline to 45 minutes and 24 hours after application
|
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)
Tidsramme: Baseline to 45 minutes and 24 hours after application
|
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)
Tidsramme: Baseline to 45 minutes and 24 hours after application
|
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
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- HA35202608
Legemiddel- og utstyrsinformasjon, studiedokumenter
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