Restorative Eye Treatment and INhance in Upper Eyelid Blepharoplasty Surgery

Completed · Not applicable

Conditions studied: Eyelid Dermatochalasis, Dermatochalasis

In brief

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.

Key facts

Study ID

NCT05007288

Run by

University of Miami

People needed

13

Starts

2020-05-01

Expected to finish

2022-07-30

Last updated by the study team

2023-04-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.
• 18 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.

Where it is running

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

Full record on ClinicalTrials.gov

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