Clinical trial NCT05742399: 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
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Tear Trough Eyelid Deformity
Dark Eyelids
Wrinkle
Keywords: periocular
rejuvenation
tear trough
hyaluronic acid
topical
dark circles
wrinkles
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2023-02-24
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: parallel assignment
Primary purpose: TREATMENT

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.

Eligibility criteria: 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:

-

Primary outcomes:
measure: The efficacy of topical hyaluronic acid nanoparticles in treatment of tear trough
timeFrame: 1 month
measure: Assessment of improvement of tear trough by topical hyaluronic acid nanoparticles
timeFrame: up to 4 weeks
measure: Patient satisfaction of topical hyaluronic acid nanoparticles in treatment of tear trough
timeFrame: 1 month
measure: Incidence of side effects of topical hyaluronic acid nanoparticles around eyes
timeFrame: up to 4 weeks
Secondary outcomes:
measure: The efficacy of topical hyaluronic acid nanoparticles in treatment of dark circles
timeFrame: up to 4 weeks
Other outcomes:
measure: The efficacy of topical hyaluronic acid nanoparticles in treatment of periocular wrinkles
timeFrame: 1 month
Locations:
city: Alexandria
country: Egypt
facility: Shaimaa Ismail Omar
state: Elazarita
Study officials:
affiliation: Alexandria University
name: Yosra S.R Elnaggar, MD
role: STUDY_CHAIR
References:
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.