Restorative Eye Treatment and INhance in Upper Eyelid Blepharoplasty Surgery

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

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.

Study Overview

• Status: Completed
• Conditions: Dermatochalasis; Eyelid Dermatochalasis
• Intervention / Treatment: Other: Restorative Eye Treatment (RET) cream; Other: INhance with Trihex Technology

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • Bascom Palmer Eye Institute, University of Miami

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Men and women who are about to have blepharoplasty at the Bascom Palmer Eye Institute by Dr. Wendy Lee.
2. 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.).
3. Participants willing to provide consent for photographic release.
4. 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.
5. Participants willing to avoid extended periods of sun exposure and all use of tanning beds for the duration of the study.
6. Participants must be willing to refrain from any other treatments or procedures to the treatment area during the duration of the study.
7. 18 years old or older.

Exclusion Criteria:

1. 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.
2. Participants who have demonstrated a previous hypersensitivity reaction to any of the ingredients of the study products.
3. Participants that have been using topical products around their upper or lower eyes within 30 days.
4. Participants who are, in the opinion of the investigator, unwilling or unable to comply with the requirements of the protocol.
5. Pregnant or lactating participants will be excluded, as well as participants planning on becoming pregnant during the study duration.
6. Participants with recent excessive exposure to sunlight or artificial UV light (e.g.: use of tanning beds/booths and/or sunbathing).
7. A participant with a history of keloids or hypertrophic scars.
8. Participants known to harbour a blood borne disease (e.g. Hepatitis A Virus (HAV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV ), HIV)
9. Special populations: Prisoners, Pregnant women, Adults unable to consent, Individuals who are not yet adults.
10. 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RET Treated Eye Plus INhance Group; 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; RET cream will be applied topically to either the left of right eyelid once daily for 4 consecutive weeks.; Other: INhance with Trihex Technology; INhance will be applied topically to both eyelids once daily for 10 consecutive days after the SOC blepharoplasty surgery.
Experimental: RET Untreated eye Plus INhance Group; 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; INhance will be applied topically to both eyelids once daily for 10 consecutive days after the SOC blepharoplasty surgery.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Miami

Publications and helpful links

General Publications

• Reivitis A, Karimi K, Griffiths C, Banayan A. A single-center, pilot study evaluating a novel TriHex peptide- and botanical-containing eye treatment compared to baseline. J Cosmet Dermatol. 2018 Jun;17(3):467-470. doi: 10.1111/jocd.12542. Epub 2018 Apr 16.
• Widgerow AD, Jacob C, Palm MD, Garruto JA, Bell M. Developing a Topical Adjunct to Injectable Procedures. J Drugs Dermatol. 2020 Apr 1;19(4):398-404. doi: 10.36849/JDD.2020.5016.
• Widgerow AD, Jiang LI, Calame A. A single-center clinical trial to evaluate the efficacy of a tripeptide/hexapeptide antiaging regimen. J Cosmet Dermatol. 2019 Feb;18(1):176-182. doi: 10.1111/jocd.12507. Epub 2018 Mar 4.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2020
• Primary Completion (Actual): April 30, 2022
• Study Completion (Actual): July 30, 2022

Study Registration Dates

• First Submitted: May 11, 2021
• First Submitted That Met QC Criteria: August 12, 2021
• First Posted (Actual): August 16, 2021

Study Record Updates

• Last Update Posted (Actual): April 11, 2023
• Last Update Submitted That Met QC Criteria: April 9, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Blepharoplasty
• Additional Relevant MeSH Terms: Skin Diseases; Genetic Diseases, Inborn; Connective Tissue Diseases; Skin Diseases, Genetic; Cutis Laxa
• Other Study ID Numbers: 20200939

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No