Periocular Rejuvenation by Topical Hyaluronic Acid Nano Particles

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

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.

Study Overview

• Status: Completed
• Conditions: Wrinkle; Tear Trough Eyelid Deformity; Dark Eyelids
• Intervention / Treatment: Drug: Hyaluronic acid NanoGel; Drug: Placebo gel

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Elazarita
    • Alexandria, Elazarita, Egypt, 21500
      • Shaimaa Ismail Omar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Hyaluronic acid nanoparticles (2%); 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; Hyaluronic acid nanoparticles (2%)
Placebo Comparator: Placebo; patients with tear trough will receive placebo conventional gel having the same color, form and packaging for 1 month	Drug: Placebo gel; conventional gel having the same color, form and packaging

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The efficacy of topical hyaluronic acid nanoparticles in treatment of periocular wrinkles	To evaluate the efficacy of topical hyaluronic acid nanoparticles in treatment of wrinkles according to Glogau wrinkles scale at baseline and after one month treatment. it ranges from 1-4. one mean youngest and 4 means oldest	1 month

Collaborators and Investigators

• Sponsor: Alexandria University
• Investigators: Study Chair: Yosra S.R Elnaggar, MD, Alexandria University

Publications and helpful links

General Publications

• 1. Diab HM, Elhosseiny R, Bedair NI, Khorkhed AH. Efficacy and safety of plasma gel versus platelet-rich plasma in periorbital rejuvenation: a comparative split-face clinical and Antera 3D camera study. Archives of dermatological research. 2021. 2. Sharad J. Dermal Fillers for the Treatment of Tear Trough Deformity: A Review of Anatomy, Treatment Techniques, and their Outcomes. Journal of cutaneous and aesthetic surgery. 2012;5(4):229-38. 3. Viana GA, Osaki MH, Cariello AJ, Damasceno RW, Osaki TH. Treatment of the tear trough deformity with hyaluronic acid. Aesthetic surgery journal. 2011;31(2):225-31. 4. Hirmand H. Anatomy and nonsurgical correction of the tear trough deformity. Plastic and reconstructive surgery. 2010;125(2):699-708. 5. Shah-Desai S, Joganathan V. Novel technique of non-surgical rejuvenation of infraorbital dark circles. Journal of cosmetic dermatology. 2021;20(4):1214-20. 6. Trinh LN, Grond SE, Gupta A. Dermal Fillers for Tear Trough Rejuvenation: A Systematic Review. Facial plastic surgery : FPS. 2021. 7. Lubart R, Yariv I, Fixler D, Lipovsky A. Topical Hyaluronic Acid Facial Cream with New Micronized Molecule Technology Effectively Penetrates and Improves Facial Skin Quality: Results from In-vitro, Ex-vivo, and In-vivo (Open-label) Studies. The Journal of clinical and aesthetic dermatology. 2019;12(10):39-44. 8. Chiari-Andréo BG, Almeida-Cincotto MGJd, Oshiro JA, Taniguchi CYY, Chiavacci LA, Isaac VLB. Chapter 5 - Nanoparticles for cosmetic use and its application. In: Grumezescu AM, editor. Nanoparticles in Pharmacotherapy: William Andrew Publishing; 2019.113-46.

Study record dates

Study Major Dates

• Study Start (Actual): December 21, 2022
• Primary Completion (Actual): September 15, 2023
• Study Completion (Actual): January 15, 2024

Study Registration Dates

• First Submitted: January 15, 2023
• First Submitted That Met QC Criteria: February 14, 2023
• First Posted (Actual): February 24, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 29, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: wrinkles; topical; hyaluronic acid; rejuvenation; dark circles; periocular; tear trough
• Additional Relevant MeSH Terms: Congenital Abnormalities; Immunologic Factors; Physiological Effects of Drugs; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Hyaluronic Acid
• Other Study ID Numbers: 0305360; 00012098 (Other Identifier: Alexandria University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Because we will publish the study in a journal

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No