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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorNakhia Impex LLC

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

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

Treatment groups

30 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators