Periocular Rejuvenation by Topical Hyaluronic Acid Nano Particles

NCT ID: NCT05742399

Last Updated: 2025-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-21

Study Completion Date

2024-01-15

Brief Summary

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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

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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.

Conditions

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Tear Trough Eyelid Deformity Dark Eyelids Wrinkle

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

parallel assignment
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
Double

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Hyaluronic acid NanoGel

Intervention Type DRUG

Hyaluronic acid nanoparticles (2%)

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo gel

Intervention Type DRUG

conventional gel having the same color, form and packaging

Interventions

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Hyaluronic acid NanoGel

Hyaluronic acid nanoparticles (2%)

Intervention Type DRUG

Placebo gel

conventional gel having the same color, form and packaging

Intervention Type DRUG

Eligibility Criteria

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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

\-
Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alexandria University

OTHER

Sponsor Role lead

Responsible Party

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Shimaa Ismail Abdelhamid

Associate professor (MD)

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yosra S.R Elnaggar, MD

Role: STUDY_CHAIR

Alexandria University

Locations

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Shaimaa Ismail Omar

Alexandria, Elazarita, Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type BACKGROUND

Other Identifiers

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00012098

Identifier Type: OTHER

Identifier Source: secondary_id

0305360

Identifier Type: -

Identifier Source: org_study_id

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