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Restorative Eye Treatment and INhance in Upper Eyelid Blepharoplasty Surgery

Primary Purpose

Eyelid Dermatochalasis, Dermatochalasis

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Restorative Eye Treatment (RET) cream

INhance with Trihex Technology

About this trial

This is an interventional supportive care trial for Eyelid Dermatochalasis focused on measuring Blepharoplasty

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Bascom Palmer Eye Institute, University of Miami

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

RET Treated Eye Plus INhance Group

RET Untreated eye Plus INhance Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Collagen Content

Assessed from eyelid tissue samples

Elastin Content

Assessed from eyelid tissue samples

Post operative bruising

Bruising will be assessed on a 1-5 scale with the higher score indicating more bruising.

Secondary Outcome Measures

Post operative swelling

Swelling will be assessed on a 1 to 5 scale with the higher score indicating more swelling

Full Information

NCT ID

NCT05007288

First Posted

May 11, 2021

Last Updated

April 9, 2023

Sponsor

University of Miami

1. Study Identification

Unique Protocol Identification Number

NCT05007288

Brief Title

Restorative Eye Treatment and INhance in Upper Eyelid Blepharoplasty Surgery

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Completed

Study Start Date

May 1, 2020 (Actual)

Primary Completion Date

April 30, 2022 (Actual)

Study Completion Date

July 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Miami

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Eyelid Dermatochalasis, Dermatochalasis

Keywords

Blepharoplasty

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

13 (Actual)

8. Arms, Groups, and Interventions

Arm Title

RET Treated Eye Plus INhance Group

Arm Type

Experimental

Arm Description

Arm Title

RET Untreated eye Plus INhance Group

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

Restorative Eye Treatment (RET) cream

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

INhance with Trihex Technology

Intervention Description

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

Primary Outcome Measure Information:

Title

Collagen Content

Description

Assessed from eyelid tissue samples

Time Frame

Up to 1 month prior to blepharoplasty surgery

Title

Elastin Content

Description

Assessed from eyelid tissue samples

Time Frame

Up to 1 month prior to blepharoplasty surgery

Title

Post operative bruising

Description

Bruising will be assessed on a 1-5 scale with the higher score indicating more bruising.

Time Frame

Up to 2 weeks post blepharoplasty surgery

Secondary Outcome Measure Information:

Title

Post operative swelling

Description

Swelling will be assessed on a 1 to 5 scale with the higher score indicating more swelling

Time Frame

Up to 2 weeks post blepharoplasty surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wendy W Lee, MD

Organizational Affiliation

University of Miami

Official's Role

Principal Investigator

Facility Information:

Facility Name

Bascom Palmer Eye Institute, University of Miami

City

Miami

State/Province

Florida

ZIP/Postal Code

33136

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

29663676

Citation

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.

Results Reference

result

PubMed Identifier

32272517

Citation

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.

Results Reference

result

PubMed Identifier

29504212

Citation

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.

Results Reference

result

Learn more about this trial

Restorative Eye Treatment and INhance in Upper Eyelid Blepharoplasty Surgery

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