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Completed

NCT Number: NCT05742399

Periocular Rejuvenation by Topical Hyaluronic Acid Nano Particles

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.

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Key information

Conditions

Tear Trough Eyelid Deformity Dark Eyelids Hyperpigmentation of Eyelids Wrinkle

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Shaimaa Ismail Omar

Alexandria, Elazarita, 21500, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Hyaluronic acid NanoGel

Drug

Hyaluronic acid nanoparticles (2%)

Placebo Gel

Drug

conventional gel having the same color, form and packaging

Primary outcomes

  1. The efficacy of topical hyaluronic acid nanoparticles in treatment of tear trough

    Time frame: 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

  2. Assessment of improvement of tear trough by topical hyaluronic acid nanoparticles

    Time frame: 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.

  3. Patient satisfaction of topical hyaluronic acid nanoparticles in treatment of tear trough

    Time frame: 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.

  4. Incidence of side effects of topical hyaluronic acid nanoparticles around eyes

    Time frame: 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 outcomes

  1. The efficacy of topical hyaluronic acid nanoparticles in treatment of dark circles

    Time frame: 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)

Other outcomes

  1. The efficacy of topical hyaluronic acid nanoparticles in treatment of periocular wrinkles

    Time frame: 1 month

    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

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Feb 24, 2023
Registry last updated
Jan 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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