Efficacy and Safety of High-Dose Oral 35 kDa Hyaluronan for Aesthetic Improvement

Study acronym: HA35-ORAL
StatusCompleted
PhaseNot applicable
Started

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Record History

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  1. Completed without a posted recruiting period
    • Eligibility criteria expanded, about 11 words
    • Secondary endpoints: details revised at 2 of 6 entries
  2. Study First Submitted
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Nakhia Impex LLC
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This is a prospective, single-arm, open-label, pilot clinical study to evaluate the efficacy and safety of high-dose oral 70 kDa hyaluronan (HA35) for aesthetic improvement. Eligible participants will receive 5 g oral HA35 once daily on an empty stomach for 40 consecutive days. The primary objectives are to assess changes in facial and body subcutaneous fullness, inflammatory erythema, facial vitality, and body weight. Safety, gastrointestinal tolerability, and additional exploratory outcomes will be evaluated throughout the intervention period. This is a minimal-risk, oral, non-pharmacological supportive care intervention.
Trial Details
NCT Number NCT07583108
Lead Sponsor Nakhia Impex LLC
Conditions
(from sponsor)		 Facial Subcutaneous Fullness, Subcutaneous Fat Accumulation, Facial Inflammatory Erythema, Dull Skin, Facial Vitality Impairment, Body Weight Management
Related terms Body Weight
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov