Efficacy and Safety of High-Dose Oral 35 kDa Hyaluronan for Aesthetic Improvement (HA35-ORAL)
7. mai 2026 oppdatert av: Nakhia Impex LLC
A Prospective, Single-Arm, Open-Label Pilot Clinical Study to Evaluate Efficacy and Safety of High-Dose Oral 35 kDa Hyaluronan (HA35) in Subjects Seeking Facial and Body Aesthetic Improvement
This is a prospective, single-arm, open-label, pilot clinical study to evaluate the efficacy and safety of high-dose oral 70 kDa hyaluronan (HA35) for aesthetic improvement.
Eligible participants will receive 5 g oral HA35 once daily on an empty stomach for 40 consecutive days.
The primary objectives are to assess changes in facial and body subcutaneous fullness, inflammatory erythema, facial vitality, and body weight.
Safety, gastrointestinal tolerability, and additional exploratory outcomes will be evaluated throughout the intervention period.
This is a minimal-risk, oral, non-pharmacological supportive care intervention.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
This prospective, single-center, single-arm, open-label pilot clinical study investigates the efficacy and safety of high-dose oral 35 kDa hyaluronan (HA35) for improving facial contour, reducing subcutaneous fullness, alleviating inflammatory erythema, enhancing facial vitality, and supporting body weight management.
Eligible subjects will take 5 g of oral HA35 once daily in the morning on an empty stomach for 40 consecutive days. Outcome assessments will be performed at baseline, Day 7, Day 14, Day 28, and Day 40 using a validated 0-10 Visual Analog Scale (VAS) to evaluate subcutaneous fat reduction, erythema improvement, facial vitality, and gastrointestinal tolerance. Body weight will be measured at each time point.
Safety evaluations include monitoring of adverse events, gastrointestinal comfort, dry eye symptoms, and overall tolerability.
This is a non-invasive, oral, non-pharmacological 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
Intervensjonell
Registrering (Antatt)
30
Fase
- Ikke aktuelt
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Ja
Beskrivelse
Inclusion Criteria:
- Age 18-60 years, male or female
- Seeking non-invasive improvement of facial/body appearance
- Presenting with facial fullness, double chin, subcutaneous fat accumulation, facial erythema, or dull skin
- Ability to complete VAS assessments and study logs
- Signed written informed consent
Exclusion Criteria:
- Aesthetic/weight loss treatments (injection, laser, liposuction, diet drugs) within 4 weeks
- Significant weight change (>3 kg) within 3 months
- Uncontrolled systemic disease (diabetes, hypertension, etc.)
- Known hypersensitivity to hyaluronan
- Pregnant or lactating women
- Participation in another clinical trial within 30 days
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
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: Oral 35 kDa Hyaluronan (HA35) Intervention Group
Participants receive 5 g of high-dose oral 35 kDa hyaluronan (HA35) once daily on an empty stomach for 40 consecutive days.
Efficacy on facial/body fat, erythema, vitality, weight, and safety will be evaluated.
|
Oral powder formulation containing high-purity35 kDa hyaluronan fragments (20-80 kDa), 5 g per day, administered orally on an empty stomach for 40 days to improve facial contour, reduce subcutaneous fullness, alleviate erythema, and enhance facial vitality.
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Facial Subcutaneous Fullness VAS Score (0-10)
Tidsramme: Baseline to Day 40
|
Change in cheek fullness and double chin prominence measured by 0-10 VAS, 0 = no improvement, 10 = maximum improvement.
|
Baseline to Day 40
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Body Subcutaneous Fullness Severity (0-10 VAS Score)
Tidsramme: Baseline to Day 40
|
Change in body subcutaneous fullness severity, assessed using a 0-10 Visual Analog Scale (VAS), where 0 = no fullness and 10 = maximum perceived subcutaneous fullness.
|
Baseline to Day 40
|
|
Change in Facial Inflammatory Erythema Severity (0-10 VAS Score)
Tidsramme: Baseline to Day 7 and Day 40
|
Change in facial inflammatory erythema severity, assessed using a 0-10 Visual Analog Scale (VAS), where 0 = no erythema and 10 = maximum redness.
|
Baseline to Day 7 and Day 40
|
|
Change in Facial Vitality (0-10 VAS Score)
Tidsramme: Baseline to Day 7 and Day 40
|
Change in perceived facial vitality and skin radiance, assessed using a 0-10 Visual Analog Scale (VAS), where 0 = dull/lifeless and 10 = vibrant/healthy appearance.
|
Baseline to Day 7 and Day 40
|
|
Change in body weight (kg)
Tidsramme: Baseline to Day 40
|
Change in body weight measured in kilograms (kg) using a calibrated digital scale, taken at the same time of day under consistent conditions.
|
Baseline to Day 40
|
|
Incidence and Severity of Treatment-Related Adverse Events
Tidsramme: From baseline to the end of the 40-day intervention period
|
Number and severity of adverse events reported during the study, including gastrointestinal discomfort, allergic reactions, or other systemic effects.
Severity is graded using the Common Terminology Criteria for Adverse Events (CTCAE).
|
From baseline to the end of the 40-day intervention period
|
|
Gastrointestinal Tolerability (0-10 VAS Score)
Tidsramme: From baseline to the end of the 40-day intervention period
|
Subject-reported gastrointestinal tolerability, assessed using a 0-10 Visual Analog Scale (VAS), where 0 = no discomfort and 10 = severe gastrointestinal distress (e.g., bloating, nausea).
|
From baseline to the end of the 40-day intervention period
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
20. mai 2026
Primær fullføring (Antatt)
20. juni 2026
Studiet fullført (Antatt)
20. juli 2026
Datoer for studieregistrering
Først innsendt
28. april 2026
Først innsendt som oppfylte QC-kriteriene
7. mai 2026
Først lagt ut (Faktiske)
13. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
13. mai 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
7. mai 2026
Sist bekreftet
1. april 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- HA35202604
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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