Dark Eyelids, Tear Trough Eyelid Deformity, Wrinkle
Conditions
Keywords
periocular, rejuvenation, tear trough, hyaluronic acid, topical, dark circles, wrinkles
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.
Interventions
DRUGHyaluronic acid NanoGel
Hyaluronic acid nanoparticles (2%)
DRUGPlacebo gel
conventional gel having the same color, form and packaging
Sponsors
Alexandria University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Double
Intervention model description
parallel assignment
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
No
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
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The efficacy of topical hyaluronic acid nanoparticles in treatment of tear trough | 1 month | 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 |
| Assessment of improvement of tear trough by topical hyaluronic acid nanoparticles | up to 4 weeks | 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. |
| Patient satisfaction of topical hyaluronic acid nanoparticles in treatment of tear trough | 1 month | 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. |
| Incidence of side effects of topical hyaluronic acid nanoparticles around eyes | up to 4 weeks | Incidence of side effects will be evaluated at all visits by reporting any adverse events such as erythema, dryness, itching, edema or hyperpigmentation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The efficacy of topical hyaluronic acid nanoparticles in treatment of dark circles | up to 4 weeks | 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) |
Other
| Measure | Time frame | Description |
|---|---|---|
| The efficacy of topical hyaluronic acid nanoparticles in treatment of periocular wrinkles | 1 month | 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 |
Countries
Egypt
Outcome results
None listed