Restorative Eye Treatment and INhance in Upper Eyelid Blepharoplasty Surgery

Not Applicable

Completed

• Conditions: Dermatochalasis; Eyelid Dermatochalasis
• Interventions: Other: Restorative Eye Treatment (RET) cream; Other: INhance with Trihex Technology

• Registration Number: NCT05007288
• Lead Sponsor: University of Miami

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-01
• Study First Submitted: 2021-05-11
• Study First Submitted QC: 2021-08-12
• Study First Posted: 2021-08-16
• Primary Completion: 2022-04-30
• Study Completion: 2022-07-30
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-09
• Last Update Posted: 2023-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RET Treated Eye Plus INhance Group	INhance with Trihex Technology	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.
RET Treated Eye Plus INhance Group	Restorative Eye Treatment (RET) cream	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.
RET Untreated eye Plus INhance Group	INhance with Trihex Technology	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Post operative swelling	Up to 2 weeks post blepharoplasty surgery	Swelling will be assessed on a 1 to 5 scale with the higher score indicating more swelling

Trial Locations

Locations (1)

Bascom Palmer Eye Institute, University of Miami; 🇺🇸 Miami, Florida, United States