Restorative Eye Treatment and INhance in Upper Eyelid Blepharoplasty Surgery

University of Miami

Status: Completed

Conditions: Dermatochalasis; Eyelid Dermatochalasis

Treatments: Other: INhance with Trihex Technology; Other: Restorative Eye Treatment (RET) cream

Study type: Interventional

Funder types: Other

Identifiers

NCT05007288

20200939

Details and patient eligibility

About

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.

Enrollment: 13 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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13 participants in 2 patient groups

RET Treated Eye Plus INhance Group

Experimental group

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.

Treatment:

Other: Restorative Eye Treatment (RET) cream

Other: INhance with Trihex Technology

RET Untreated eye Plus INhance Group

Experimental group

Description:

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.

Treatment:

Other: INhance with Trihex Technology