Periocular Rejuvenation by Topical Hyaluronic Acid Nano Particles

Wrinkle Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05742399
• Other study ID #: 0305360
• Secondary ID: 00012098
• Status: Recruiting
• Phase: N/A
• Start date: December 21, 2022
• Est. completion date: December 2023

Study information

• Verified date: July 2023
• Source: Alexandria University
• Contact: Shaimaa I Omar, MD
• Phone: +201001949540
• Email: shimoderma[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2023
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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:

-

Related Conditions & MeSH terms

• Congenital Abnormalities
• Tear Trough Eyelid Deformity
• Wrinkle

Intervention

Drug:
• Hyaluronic acid NanoGel
Hyaluronic acid nanoparticles (2%)
• Placebo gel
conventional gel having the same color, form and packaging

Locations

Country	Name	City	State
Egypt	Shaimaa Ismail Omar	Alexandria	Elazarita

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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
Primary	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
Primary	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
Primary	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	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