Restorative Eye Treatment and INhance in Upper Eyelid Blepharoplasty Surgery

Dermatochalasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05007288
• Other study ID #: 20200939
• Status: Completed
• Phase: N/A
• Start date: May 1, 2020
• Est. completion date: July 30, 2022

Study information

• Verified date: April 2023
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: July 30, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cutis Laxa
• Dermatochalasis

Intervention

Other:
• Restorative Eye Treatment (RET) cream
RET cream will be applied topically to either the left of right eyelid once daily for 4 consecutive weeks.
• INhance with Trihex Technology
INhance will be applied topically to both eyelids once daily for 10 consecutive days after the SOC blepharoplasty surgery.

Locations

Country	Name	City	State
United States	Bascom Palmer Eye Institute, University of Miami	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

References & Publications (3)

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 — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Collagen Content	Assessed from eyelid tissue samples	Up to 1 month prior to blepharoplasty surgery
Primary	Elastin Content	Assessed from eyelid tissue samples	Up to 1 month prior to blepharoplasty surgery
Primary	Post operative bruising	Bruising will be assessed on a 1-5 scale with the higher score indicating more bruising.	Up to 2 weeks post blepharoplasty surgery
Secondary	Post operative swelling	Swelling will be assessed on a 1 to 5 scale with the higher score indicating more swelling	Up to 2 weeks post blepharoplasty surgery