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

May 7, 2026 updated by: 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
Other Names:
  • HA35 Facial Aesthetic Gel
  • Overnight HA35 Gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Facial Subcutaneous Fat Thickness NRS Score (0-10)
Time Frame: 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Facial Inflammatory Erythema Severity (0-10 NRS Score)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nakhia Impex LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

June 20, 2026

Study Completion (Estimated)

July 20, 2026

Study Registration Dates

First Submitted

April 28, 2026

First Submitted That Met QC Criteria

May 7, 2026

First Posted (Actual)

May 13, 2026

Study Record Updates

Last Update Posted (Actual)

May 13, 2026

Last Update Submitted That Met QC Criteria

May 7, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HA35202603

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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