Periocular Rejuvenation by Topical Hyaluronic Acid Nano Particles

Sponsor

Alexandria University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05742399

Collaborator

(none)

Enrollment

Location

Arms

7.3

Anticipated Duration (Months)

4.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Tear Trough Eyelid Deformity Dark Eyelids Wrinkle	Drug: Hyaluronic acid NanoGel Drug: Placebo gel	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

parallel assignmentparallel assignment

Masking:

Double (Participant, Investigator)

Masking Description:

Double

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Dec 21, 2022

Anticipated Primary Completion Date :

May 1, 2023

Anticipated Study Completion Date :

Aug 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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)

Other Outcome Measures

The efficacy of topical hyaluronic acid nanoparticles in treatment of periocular wrinkles [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.