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

NCT07584811 | Not Yet Recruiting

• 1 other identifier: HA35202603
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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; Facial Aesthetic Improvement; Nasal Alar Pore Enlargement

Keywords

Hyaluronan; 35 kDa Hyaluronan; HA35; Overnight Occlusive; Topical Gel; Facial Fat; Facial Erythema; Skin Radiance; Pore Improvement; Non-invasive Aesthetic; Pilot Clinical Study

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to after 1 application and after 5 applications

Secondary Outcomes (5)

• Change in Facial Inflammatory Erythema Severity (0-10 NRS Score)

  Baseline (Day 0) to Day 2 and Day 10

• Change in Facial Skin Radiance (0-10 NRS Score)

  Baseline (Day 0) to Day 2 and Day 10

• Change in Nasal Alar Pore Enlargement Severity (0-10 NRS Score)

  Baseline (Day 0) to Day 2 and Day 10

• Incidence and Severity of Local Skin Adverse Events

  Baseline (Day 0) to Day 2 and Day 10

• Incidence and Severity of Local Skin Adverse Events

  From Day 0 to Day 10

Study Arms (1)

HA35 Overnight Occlusive Topical Gel Group

EXPERIMENTAL

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

Interventions

10% High-Concentration 35 kDa Hyaluronan (HA35) Facial Occlusive Gel DEVICE

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

HA35 Overnight Occlusive Topical Gel Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nakhia Impex LLC: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2026
• First Posted: May 13, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): June 20, 2026
• Study Completion (Estimated): July 20, 2026
• Last Updated: May 13, 2026

Record last verified: 2026-04