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Not yet recruiting NCT07584811

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

No phase Interventional Facial Subcutaneous Fat Facial Erythema Skin Dullness Nasal Alar Pore Enlargement

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 10% High-Concentration 35 kDa Hyaluronan (HA35) Facial Occlusive Gel.
Who it may be relevant to
Registry conditions: Facial Subcutaneous Fat, Facial Erythema, Skin Dullness, Nasal Alar Pore Enlargement. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

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.

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.

Primary outcome measures

  • Change in Facial Subcutaneous Fat Thickness NRS Score (0-10) [Time frame: Baseline to after 1 application and after 5 applications]
Secondary outcome measures (5)
  • Change in Facial Inflammatory Erythema Severity (0-10 NRS Score) [Time frame: 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 Nasal Alar Pore Enlargement Severity (0-10 NRS Score) [Time frame: 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]
  • Incidence and Severity of Local Skin Adverse Events [Time frame: From Day 0 to Day 10]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07584811 · HA35202603

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗