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Efficacy and Safety of High-Dose Oral 35 kDa Hyaluronan for Aesthetic Improvement (HA35-ORAL)

7. maj 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

30

Fase

  • Ikke anvendelig

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde 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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Enhed: High-Dose Oral 35 kDa Hyaluronan (HA35)
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 navne:
  • Oral HA35
  • 35 kDa Hyaluronan

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Nakhia Impex LLC

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

20. maj 2026

Primær færdiggørelse (Anslået)

20. juni 2026

Studieafslutning (Anslået)

20. juli 2026

Datoer for studieregistrering

Først indsendt

28. april 2026

Først indsendt, der opfyldte QC-kriterier

7. maj 2026

Først opslået (Faktiske)

13. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

13. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. maj 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • HA35202604

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Facial Subcutaneous Fullness

Kliniske forsøg med High-Dose Oral 35 kDa Hyaluronan (HA35)

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