Periocular Rejuvenation by Topical Hyaluronic Acid Nano Particles

Alexandria University

Status and phase: Completed; Phase 2; Phase 1

Conditions: Dark Eyelids; Tear Trough Eyelid Deformity; Wrinkle

Treatments: Drug: Placebo gel; Drug: Hyaluronic acid NanoGel

Study type: Interventional

Funder types: Other

Identifiers

NCT05742399

00012098

0305360

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups, including a placebo group

Hyaluronic acid nanoparticles (2%)

Active Comparator group

Description:

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

Treatment:

Drug: Hyaluronic acid NanoGel

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo gel