Periocular Rejuvenation by Topical Hyaluronic Acid Nano Particles

Study Overview
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Brief Summary
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In this study, The investigators aims to evaluate the efficacy and safety of topical hyaluronic acid nanoparticles as a novel nanodermatological tool in periocular rejuvenation as a replacement approach of invasive dermal filler injections.

Detailed Description
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Tear trough deformity is a main concern of many people (males or females) with age range of 21 to 65 years old or older. Such condition is characterized by a sunken appearance of the eye that results in an aged and dissipated appearance to the eye.Treatment modalities range from camouflage make up, laser resurfacing, platelet-rich plasma therapy, carboxy therapy, mesotherapy, volume augmentation with injectable hyaluronic acid fillers and fat, as well as surgical procedures such as blepharoplasty. Consequently, safe, effective and less invasive treatment options of the tear trough have remained a challenge. The study will include 30 adult patients (male or female) suffering tear trough deformity. They will be selected from Dermatology Outpatient Clinic of Alexandria Main University Hospital.

Official Title
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Clinical Evaluation of the Efficacy and Safety of Novel Drug-free Hyaluronic Acid Topical Nano-carrier in Periocular Rejuvenation

Conditions
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Tear Trough Eyelid Deformity, Dark Eyelids, Wrinkle

Intervention / Treatment
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* Drug: Hyaluronic acid NanoGel
* Drug: Placebo gel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Is a healthy male or female between 21 and 65 years old Is voluntarily willing to consent to participate in the study Is willing to comply with all requirements of the study including being photographed, follow post treatment care instructions, to attend all treatment, and follow up visits Willingness to waive rights to use of still photos of themselves for research, marketing, or promotional reasons, including on the internet and on social media outlets. Willingness to refrain from other surgical, laser, or injectable treatments in the periorbital region during the entire duration of the study. Ability to provide informed consent. Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: parallel assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Hyaluronic acid nanoparticles (2%)<br>patients with tear trough will receive hyaluronic acid nano-gel (2%) 2 applications / day (morning and evening) on tear troughs for 1 month | Drug: Hyaluronic acid NanoGel<br>* Hyaluronic acid nanoparticles (2%)<br>|
| Placebo Comparator: Placebo<br>patients with tear trough will receive placebo conventional gel having the same color, form and packaging for 1 month | Drug: Placebo gel<br>* conventional gel having the same color, form and packaging<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The efficacy of topical hyaluronic acid nanoparticles in treatment of tear trough | To evaluate the efficacy of topical hyaluronic acid nanoparticles in in treatment of tear trough using Sadick et al scale at baseline and after one month treatment. the score will range from 1-14, in which the higher the score, the worse the outcome | 1 month | 
| Assessment of improvement of tear trough by topical hyaluronic acid nanoparticles | Physician assessment will be done at the one-month follow up visit through blinded evaluator-assessed Global Aesthetic Improvement Score. the score will range from 1-5, in which score 1 is associated with best results and score 5 with worst results. | up to 4 weeks | 
| Patient satisfaction of topical hyaluronic acid nanoparticles in treatment of tear trough | Patient satisfaction will be assessed using a visual analogue scale which is ranged from 0-3, 0 is associated with least satisfaction and 3 with the best satisfaction. | 1 month | 
| Incidence of side effects of topical hyaluronic acid nanoparticles around eyes | Incidence of side effects will be evaluated at all visits by reporting any adverse events such as erythema, dryness, itching, edema or hyperpigmentation. | up to 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The efficacy of topical hyaluronic acid nanoparticles in treatment of dark circles | To evaluate the efficacy of topical hyaluronic acid nanoparticles in treatment of of dark circles according to the intenisty of pigmentaion (mild, moderate or intense) | up to 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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periocular, rejuvenation, tear trough, hyaluronic acid, topical, dark circles, wrinkles