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

Study acronym: HA35-FACIAL
StatusCompleted
PhaseNot applicable
Started

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Record History

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  1. Completed without a posted recruiting period
    • Study completion date changed from estimate of Jul 20, 2026 to Aug 20, 2026
    • Eligibility criteria expanded, about 11 words
    • Secondary endpoints: details revised at 3 of 5 entries
  2. Study First Submitted
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07584811
Lead Sponsor Nakhia Impex LLC
Conditions
(from sponsor)		 Facial Subcutaneous Fat, Facial Erythema, Skin Dullness, Nasal Alar Pore Enlargement, Facial Aesthetic Improvement
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov