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Efficacy and Safety of Overnight Occlusive HA35 Gel for Facial Aesthetic Improvement (HA35-FACIAL)

7. maj 2026 opdateret af: Nakhia Impex LLC

A Prospective, Single-Arm, Open-Label Pilot Clinical Study to Evaluate Efficacy and Safety of Overnight Occlusive Topical 10% 35 kDa Hyaluronan (HA35) Gel for Facial Subcutaneous Fat Appearance, Erythema, Skin Radiance, and Pore Condition

This is a prospective, single-arm, open-label, pilot clinical study to evaluate the efficacy and safety of overnight occlusive topical application of 10% high-concentration 35 kDa hyaluronan (HA35) gel for facial aesthetic improvement. Eligible participants will receive overnight occlusive application once every 2 days for a total of 5 treatments over 10 days. The primary objectives are to assess changes in facial subcutaneous fat appearance, inflammatory erythema, skin radiance, and nasal alar pore enlargement after 1 and 5 applications. Safety and local tolerability will be evaluated throughout the study period. This is a minimal-risk, non-pharmacological, non-invasive aesthetic 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 overnight occlusive topical 10% high-concentration 35 kDa hyaluronan (HA35) gel for improving multiple facial aesthetic outcomes, including subcutaneous fat appearance, inflammatory erythema, skin radiance, and nasal alar pore condition.

Eligible subjects will apply HA35 gel to the entire face before sleep, covered with an occlusive film to retain moisture, and left in place overnight. The intervention will be administered once every 2 days for 5 applications over 10 days.

Outcomes will be assessed at baseline, after 1 application, and after 5 applications using a standardized 0-10 Numeric Rating Scale (NRS) for subcutaneous fat thickness, erythema severity, skin radiance, and pore enlargement. Local skin tolerability and adverse events will be monitored throughout the study.

This is a non-invasive, non-pharmacological aesthetic intervention with minimal risk. All procedures are conducted in accordance with the Declaration of Helsinki, and written informed consent is 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

Ingen

Beskrivelse

Inclusion Criteria:

  • Age 18-60 years, male or female
  • Seeking non-invasive improvement of facial appearance
  • Presenting with at least one of: facial subcutaneous fat accumulation, facial erythema, skin dullness, nasal alar pore enlargement
  • Baseline NRS score ≥2 for at least one target parameter
  • Ability to complete self-assessments
  • Signed written informed consent

Exclusion Criteria:

  • Facial aesthetic treatments (injection, laser, fat reduction, peeling) within 2 weeks
  • Active facial dermatitis, infection, or open wounds
  • Known hypersensitivity to hyaluronan or gel components
  • Pregnant or lactating women
  • Severe systemic disease or uncontrolled medical condition

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: HA35 Overnight Occlusive Topical Gel Group
Participants receive 10% high-concentration 35 kDa HA35 gel as overnight occlusive topical application to the entire face, once every 2 days for 5 applications over 10 days. Efficacy on facial fat, erythema, radiance, pores, and safety will be evaluated.
Enhed: 10% High-Concentration 35 kDa Hyaluronan (HA35) Facial Occlusive Gel
A topical, non-pharmacological facial gel containing 10% high-concentration 35 kDa hyaluronan fragment. Applied under occlusive conditions overnight to improve facial subcutaneous fat appearance, reduce erythema, enhance radiance, and improve pore condition.
Andre navne:
  • HA35 Facial Aesthetic Gel
  • Overnight HA35 Gel

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Facial Subcutaneous Fat Thickness NRS Score (0-10)
Tidsramme: Baseline to after 1 application and after 5 applications
Change in facial subcutaneous fat thickness assessed by 0-10 NRS, 0 = normal, 10 = maximum thickness.
Baseline to after 1 application and after 5 applications

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Facial Inflammatory Erythema Severity (0-10 NRS Score)
Tidsramme: Baseline (Day 0) to Day 2 and Day 10
Change in facial inflammatory erythema severity, assessed using a 0-10 Numeric Rating Scale (NRS), where 0 = no redness and 10 = maximum facial redness and inflammation.
Baseline (Day 0) to Day 2 and Day 10
Change in Facial Skin Radiance (0-10 NRS Score)
Tidsramme: Baseline (Day 0) to Day 2 and Day 10
Change in perceived facial skin radiance and brightness, assessed using a 0-10 Numeric Rating Scale (NRS), where 0 = dull/lifeless skin and 10 = bright, glowing skin.
Baseline (Day 0) to Day 2 and Day 10
Change in Nasal Alar Pore Enlargement Severity (0-10 NRS Score)
Tidsramme: Baseline (Day 0) to Day 2 and Day 10
Change in the severity of nasal alar pore enlargement, assessed using a 0-10 Numeric Rating Scale (NRS), where 0 = no visible pores and 10 = maximum pore size and visibility.
Baseline (Day 0) to Day 2 and Day 10
Incidence and Severity of Local Skin Adverse Events
Tidsramme: Baseline (Day 0) to Day 2 and Day 10
Number and severity of treatment-related local skin adverse events (e.g., irritation, redness, allergic reaction) reported during the study. Severity is graded using the Common Terminology Criteria for Adverse Events (CTCAE).
Baseline (Day 0) to Day 2 and Day 10
Incidence and Severity of Local Skin Adverse Events
Tidsramme: From Day 0 to Day 10
Number and severity of treatment-related local skin adverse events (e.g., irritation, redness, allergic reaction) reported during the study. Severity is graded using the Common Terminology Criteria for Adverse Events (CTCAE).
From Day 0 to Day 10

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)

1. 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

Andre undersøgelses-id-numre

  • HA35202603

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 .

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