Periocular Rejuvenation by Topical Hyaluronic Acid Nano Particles

NCT05742399 | Completed Phase 1

• 2 other identifiers: 030536000012098
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Tear Trough Eyelid Deformity; Dark Eyelids; Wrinkle

Keywords

periocular; rejuvenation; tear trough; hyaluronic acid; topical; dark circles; wrinkles

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (1)

• The efficacy of topical hyaluronic acid nanoparticles in treatment of dark circles

  up to 4 weeks

Other Outcomes (1)

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

  1 month

Study Arms (2)

Hyaluronic acid nanoparticles (2%)

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo gel

Interventions

Hyaluronic acid NanoGel DRUG

Hyaluronic acid nanoparticles (2%)

Hyaluronic acid nanoparticles (2%)

Placebo gel DRUG

conventional gel having the same color, form and packaging

Placebo

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Shaimaa Ismail Omar

Alexandria, Elazarita, 21500, Egypt

Location

Related 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 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.

  BACKGROUND

MeSH Terms

Conditions

Hyperpigmentation of Eyelids

Study Officials

• Yosra S.R Elnaggar, MD

  Alexandria University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor (MD)

Model Details: parallel assignment

Study Record Dates

• First Submitted: January 15, 2023
• First Posted: February 24, 2023
• Study Start: December 21, 2022
• Primary Completion: September 15, 2023
• Study Completion: January 15, 2024
• Last Updated: January 31, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)