Restorative Eye Treatment and INhance in Upper Eyelid Blepharoplasty Surgery

NCT05007288 | Completed

• 1 other identifier: 20200939
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Eyelid Dermatochalasis; Dermatochalasis

Keywords

Blepharoplasty

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Post operative swelling

  Up to 2 weeks post blepharoplasty surgery

Study Arms (2)

RET Treated Eye Plus INhance Group

EXPERIMENTAL

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; Other: INhance with Trihex Technology

RET Untreated eye Plus INhance Group

EXPERIMENTAL

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

Interventions

Restorative Eye Treatment (RET) cream OTHER

RET cream will be applied topically to either the left of right eyelid once daily for 4 consecutive weeks.

RET Treated Eye Plus INhance Group

INhance with Trihex Technology OTHER

INhance will be applied topically to both eyelids once daily for 10 consecutive days after the SOC blepharoplasty surgery.

RET Treated Eye Plus INhance Group; RET Untreated eye Plus INhance Group

Eligibility Criteria

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

You may qualify if:

• 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.
• years old or older.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

Bascom Palmer Eye Institute, University of Miami

Miami, Florida, 33136, United States

Location

Related Publications (3)

• 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.

  PMID: 29663676 RESULT

• 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.

  PMID: 32272517 RESULT

• 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.

  PMID: 29504212 RESULT

MeSH Terms

Conditions

Cutis Laxa

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Officials

• Wendy W Lee, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Ophthalmology

Study Record Dates

• First Submitted: May 11, 2021
• First Posted: August 16, 2021
• Study Start: May 1, 2020
• Primary Completion: April 30, 2022
• Study Completion: July 30, 2022
• Last Updated: April 11, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)