Clinical trial NCT05007288: 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
Overall status: COMPLETED
Phase: NA
Conditions: Eyelid Dermatochalasis
Dermatochalasis
Keywords: Blepharoplasty
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2021-08-16
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Collagen Content
timeFrame: Up to 1 month prior to blepharoplasty surgery
measure: Elastin Content
timeFrame: Up to 1 month prior to blepharoplasty surgery
measure: Post operative bruising
timeFrame: Up to 2 weeks post blepharoplasty surgery
Secondary outcomes:
measure: Post operative swelling
timeFrame: Up to 2 weeks post blepharoplasty surgery
Other outcomes:
Locations:
city: Miami
country: United States
facility: Bascom Palmer Eye Institute, University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Wendy W Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.