An interventional study of 10% High-Concentration 35 kDa Hyaluronan (HA35) Facial Occlusive Gel in Facial Subcutaneous Fat, Facial Erythema and Skin Dullness, sponsored by Nakhia Impex LLC. Completed at 1 site in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by Nakhia Impex LLC · Not applicable, Interventional, and Supportive care
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.
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.
131 studies on the registry are indexed under Erythema; 17 are open to participants now.
This study's enrollment of 30 is below the median of 50 across 114 interventional studies indexed under Erythema.
Browse Erythema studies →Nakhia Impex LLC is the lead sponsor of 15 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Also known as: HA35 Facial Aesthetic Gel, Overnight HA35 Gel
Change in Facial Subcutaneous Fat Thickness NRS Score (0-10)
Change in facial subcutaneous fat thickness assessed by 0-10 NRS, 0 = normal, 10 = maximum thickness.
Time frame: Baseline to after 1 application and after 5 applications
Change in Facial Inflammatory Erythema Severity (0-10 NRS Score)
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.
Time frame: Baseline (Day 0) to Day 2 and Day 10
Change in Facial Skin Radiance (0-10 NRS Score)
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.
Time frame: Baseline (Day 0) to Day 2 and Day 10
Change in Nasal Alar Pore Enlargement Severity (0-10 NRS Score)
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.
Time frame: Baseline (Day 0) to Day 2 and Day 10
Incidence and Severity of Local Skin Adverse Events
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).
Time frame: Baseline (Day 0) to Day 2 and Day 10
Incidence and Severity of Local Skin Adverse Events
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).
Time frame: From Day 0 to Day 10
Ran from May 2026 to primary completion in Jun 2026, 1 month.
Of 43 interventional studies with no phase under Erythema, half reached primary completion within 3 months of starting (the median), counting those still running; a quarter within 1 and three quarters within 11. This study's 1 month is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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