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Completed

NCT Number: NCT05007288

Restorative Eye Treatment and INhance in Upper Eyelid Blepharoplasty Surgery

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bascom Palmer Eye Institute, University of Miami

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

INhance with Trihex Technology

Other

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

Primary outcomes

  1. Collagen Content

    Time frame: Up to 1 month prior to blepharoplasty surgery

    Assessed from eyelid tissue samples

  2. Elastin Content

    Time frame: Up to 1 month prior to blepharoplasty surgery

    Assessed from eyelid tissue samples

  3. Post operative bruising

    Time frame: Up to 2 weeks post blepharoplasty surgery

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

Secondary outcomes

  1. Post operative swelling

    Time frame: Up to 2 weeks post blepharoplasty surgery

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

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Aug 16, 2021
Registry last updated
Apr 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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