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Periocular Rejuvenation by Topical Hyaluronic Acid Nano Particles

Primary Purpose

Tear Trough Eyelid Deformity, Dark Eyelids, Wrinkle

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Hyaluronic acid NanoGel
Placebo gel
Sponsored by
Alexandria University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tear Trough Eyelid Deformity focused on measuring periocular, rejuvenation, tear trough, hyaluronic acid, topical, dark circles, wrinkles

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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. Exclusion Criteria: -

Sites / Locations

  • Shaimaa Ismail OmarRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Hyaluronic acid nanoparticles (2%)

Placebo

Arm Description

patients with tear trough will receive hyaluronic acid nano-gel (2%) 2 applications / day (morning and evening) on tear troughs for 1 month

patients with tear trough will receive placebo conventional gel having the same color, form and packaging for 1 month

Outcomes

Primary Outcome Measures

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
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.
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.
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.

Secondary Outcome Measures

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)

Full Information

First Posted
January 15, 2023
Last Updated
July 18, 2023
Sponsor
Alexandria University
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1. Study Identification

Unique Protocol Identification Number
NCT05742399
Brief Title
Periocular Rejuvenation by Topical Hyaluronic Acid Nano Particles
Official Title
Clinical Evaluation of the Efficacy and Safety of Novel Drug-free Hyaluronic Acid Topical Nano-carrier in Periocular Rejuvenation
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 21, 2022 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alexandria University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tear Trough Eyelid Deformity, Dark Eyelids, Wrinkle
Keywords
periocular, rejuvenation, tear trough, hyaluronic acid, topical, dark circles, wrinkles

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
parallel assignment
Masking
ParticipantInvestigator
Masking Description
Double
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hyaluronic acid nanoparticles (2%)
Arm Type
Active Comparator
Arm Description
patients with tear trough will receive hyaluronic acid nano-gel (2%) 2 applications / day (morning and evening) on tear troughs for 1 month
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
patients with tear trough will receive placebo conventional gel having the same color, form and packaging for 1 month
Intervention Type
Drug
Intervention Name(s)
Hyaluronic acid NanoGel
Intervention Description
Hyaluronic acid nanoparticles (2%)
Intervention Type
Drug
Intervention Name(s)
Placebo gel
Intervention Description
conventional gel having the same color, form and packaging
Primary Outcome Measure Information:
Title
The efficacy of topical hyaluronic acid nanoparticles in treatment of tear trough
Description
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
Time Frame
1 month
Title
Assessment of improvement of tear trough by topical hyaluronic acid nanoparticles
Description
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.
Time Frame
up to 4 weeks
Title
Patient satisfaction of topical hyaluronic acid nanoparticles in treatment of tear trough
Description
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.
Time Frame
1 month
Title
Incidence of side effects of topical hyaluronic acid nanoparticles around eyes
Description
Incidence of side effects will be evaluated at all visits by reporting any adverse events such as erythema, dryness, itching, edema or hyperpigmentation.
Time Frame
up to 4 weeks
Secondary Outcome Measure Information:
Title
The efficacy of topical hyaluronic acid nanoparticles in treatment of dark circles
Description
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)
Time Frame
up to 4 weeks
Other Pre-specified Outcome Measures:
Title
The efficacy of topical hyaluronic acid nanoparticles in treatment of periocular wrinkles
Description
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
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shaimaa I Omar, MD
Phone
+201001949540
Email
shimoderma@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Shaimaa I Omar
Phone
+201001949540
Email
shimoderma@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yosra S.R Elnaggar, MD
Organizational Affiliation
Alexandria University
Official's Role
Study Chair
Facility Information:
Facility Name
Shaimaa Ismail Omar
City
Alexandria
State/Province
Elazarita
ZIP/Postal Code
21500
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shaimaa I Omar
Phone
01001949540
Email
shimoderma@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Because we will publish the study in a journal
Citations:
Citation
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.
Results Reference
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Periocular Rejuvenation by Topical Hyaluronic Acid Nano Particles

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