Periocular Rejuvenation by Topical Hyaluronic Acid Nano Particles

Phase 1

Completed

• Conditions: Dark Eyelids; Tear Trough Eyelid Deformity; Wrinkle
• Interventions: Drug: Hyaluronic acid NanoGel; Drug: Placebo gel

• Registration Number: NCT05742399
• Lead Sponsor: Alexandria University

Brief Summary

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

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.

Study Timeline

• Study Start: 2022-12-21
• Study First Submitted: 2023-01-15
• Study First Submitted QC: 2023-02-14
• Study First Posted: 2023-02-24
• Primary Completion: 2023-09-15
• Study Completion: 2024-01-15
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-29
• Last Update Posted: 2025-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Is a healthy male or female between 21 and 65 years old
2. Is voluntarily willing to consent to participate in the study
3. 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
4. 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.
5. Willingness to refrain from other surgical, laser, or injectable treatments in the periorbital region during the entire duration of the study.
6. Ability to provide informed consent.

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hyaluronic acid nanoparticles (2%)	Hyaluronic acid NanoGel	patients with tear trough will receive hyaluronic acid nano-gel (2%) 2 applications / day (morning and evening) on tear troughs for 1 month
Placebo	Placebo gel	patients with tear trough will receive placebo conventional gel having the same color, form and packaging for 1 month

Primary Outcome Measures

Name	Time	Method
The efficacy of topical hyaluronic acid nanoparticles in treatment of tear trough	1 month	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
Assessment of improvement of tear trough by topical hyaluronic acid nanoparticles	up to 4 weeks	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.
Patient satisfaction of topical hyaluronic acid nanoparticles in treatment of tear trough	1 month	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.
Incidence of side effects of topical hyaluronic acid nanoparticles around eyes	up to 4 weeks	Incidence of side effects will be evaluated at all visits by reporting any adverse events such as erythema, dryness, itching, edema or hyperpigmentation.

Secondary Outcome Measures

Name	Time	Method
The efficacy of topical hyaluronic acid nanoparticles in treatment of dark circles	up to 4 weeks	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)

Trial Locations

Locations (1)

Shaimaa Ismail Omar; 🇪🇬 Alexandria, Elazarita, Egypt