Restorative Eye Treatment and INhance in Upper Eyelid Blepharoplasty Surgery

Study Overview
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Brief Summary
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The purpose of this research is to determine if restorative eye treatment (RET) and Inhance with trihex technology used before and after blepharoplasty can lead to better skin quality before undergoing blepharoplasty, and if these products will lead to less visible scarring and faster healing after blepharoplasty.

Official Title
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A Single Center Evaluation of Restorative Eye Treatment and Inhance With Trihex Technology Effects on the Aesthetic Outcomes When Used Pre and Post Upper Blepharoplasty

Conditions
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Eyelid Dermatochalasis, Dermatochalasis

Intervention / Treatment
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* Other: Restorative Eye Treatment (RET) cream
* Other: INhance with Trihex Technology


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women who are about to have blepharoplasty at the Bascom Palmer Eye Institute by Dr. Wendy Lee. Men and women with no known medical conditions that, in the investigator's opinion, may affect wound healing and interfere with study participation (e.g. diabetes, skin disorder etc.). Participants willing to provide consent for photographic release. Participants must not be using any new skincare products, other than the study products provided, on the treatment area for the duration of the study. Participants willing to avoid extended periods of sun exposure and all use of tanning beds for the duration of the study. Participants must be willing to refrain from any other treatments or procedures to the treatment area during the duration of the study. 18 years old or older. Exclusion Criteria: Any dermatological disorder or poor health, which in the investigator's opinion, may interfere with the accurate evaluation of the participants' skin characteristics or inhibit wound healing. Participants who have demonstrated a previous hypersensitivity reaction to any of the ingredients of the study products. Participants that have been using topical products around their upper or lower eyes within 30 days. Participants who are, in the opinion of the investigator, unwilling or unable to comply with the requirements of the protocol. Pregnant or lactating participants will be excluded, as well as participants planning on becoming pregnant during the study duration. Participants with recent excessive exposure to sunlight or artificial UV light (e.g.: use of tanning beds/booths and/or sunbathing). A participant with a history of keloids or hypertrophic scars. Participants known to harbour a blood borne disease (e.g. Hepatitis A Virus (HAV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV ), HIV) Special populations: Prisoners, Pregnant women, Adults unable to consent, Individuals who are not yet adults. Have any condition that, in the opinion of the investigator, would compromise the well-being of the patient or the study or prevent the patient from meeting or performing study requirements.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RET Treated Eye Plus INhance Group<br>Participants randomized to receive the restorative eye treatment (RET) intervention on either the left or right eyelid will administer the RET cream on the eyelid daily for 4 consecutive weeks prior to scheduled standard of care (SOC) blepharoplasty. After surgery, participants will receive INhance with Trihex technology applied to both eyelids daily for 10 consecutive days post surgery. | Other: Restorative Eye Treatment (RET) cream<br>* RET cream will be applied topically to either the left of right eyelid once daily for 4 consecutive weeks.<br>Other: INhance with Trihex Technology<br>* INhance will be applied topically to both eyelids once daily for 10 consecutive days after the SOC blepharoplasty surgery.<br>|
| Experimental: RET Untreated eye Plus INhance Group<br>Participants randomized to not receive the RET intervention will not receive any intervention prior to scheduled standard of care (SOC) blepharoplasty. After surgery, participants will receive INhance with Trihex technology applied to both eyelids daily for 10 consecutive days post surgery. | Other: INhance with Trihex Technology<br>* INhance will be applied topically to both eyelids once daily for 10 consecutive days after the SOC blepharoplasty surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Collagen Content | Assessed from eyelid tissue samples | Up to 1 month prior to blepharoplasty surgery | 
| Elastin Content | Assessed from eyelid tissue samples | Up to 1 month prior to blepharoplasty surgery | 
| Post operative bruising | Bruising will be assessed on a 1-5 scale with the higher score indicating more bruising. | Up to 2 weeks post blepharoplasty surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post operative swelling | Swelling will be assessed on a 1 to 5 scale with the higher score indicating more swelling | Up to 2 weeks post blepharoplasty surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blepharoplasty