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Hyaluronic acid NanoGel for periocular rejuvenation
NCT05742399Phase 2
Key facts
- Status
- Completed
- Start
- Dec 2022
- Primary completion
- Sep 2023
- Countries
- 1
- Sponsor
- Alexandria University
- Modality
- Hydrogel Systems
- Drugs
- hyaluronic acid sodium composite gel for injection
- Conditions
- tear trough deformityperiorbital hyperpigmentation (POH)wrinkle
01
Overview
Phase 2, randomised, double-blind trial of hyaluronic acid sodium composite gel for injection in tear trough deformity, periorbital hyperpigmentation (POH) and wrinkle (2 arms), sponsored by Alexandria University. Primary endpoints: Efficacy of topical hyaluronic acid nanoparticles in treatment of tear trough at 1 month, Assessment of improvement of tear trough by topical hyaluronic acid nanoparticles at 4 weeks and 2 more. Started Dec 2022; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Hyaluronic acid nanoparticles (2%)
Topical hyaluronic acid nano-gel (2%)
Placebo
Conventional gel having the same color, form and packaging
03
Who it enrols
Healthy adults aged 21-65 with tear trough deformity willing to comply with study requirements and refrain from other periorbital treatments.
04
Endpoints
Primary
Efficacy of topical hyaluronic acid nanoparticles in treatment of tear trough
Assessment of improvement of tear trough by topical hyaluronic acid nanoparticles
Patient satisfaction of topical hyaluronic acid nanoparticles in treatment of tear trough
Incidence of side effects of topical hyaluronic acid nanoparticles around eyes
Secondary
Efficacy of topical hyaluronic acid nanoparticles in treatment of dark circles
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