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Efficacy and Safety of Overnight Occlusive HA35 Gel for Facial Aesthetic Improvement

NCT07584811 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-05-13

No results posted yet for this study

Summary

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.

Conditions

  • Facial Subcutaneous Fat
  • Facial Erythema
  • Skin Dullness
  • Nasal Alar Pore Enlargement
  • Facial Aesthetic Improvement

Interventions

DEVICE

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.

Sponsors & Collaborators

  • Nakhia Impex LLC

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-01
Primary Completion
2026-06-20
Completion
2026-07-20

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07584811 on ClinicalTrials.gov