Dermatochalasis, Eyelid Dermatochalasis
Conditions
Keywords
Blepharoplasty
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.
Interventions
OTHERRestorative Eye Treatment (RET) cream
RET cream will be applied topically to either the left of right eyelid once daily for 4 consecutive weeks.
OTHERINhance with Trihex Technology
INhance will be applied topically to both eyelids once daily for 10 consecutive days after the SOC blepharoplasty surgery.
Sponsors
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Collagen Content | Up to 1 month prior to blepharoplasty surgery | Assessed from eyelid tissue samples |
| Elastin Content | Up to 1 month prior to blepharoplasty surgery | Assessed from eyelid tissue samples |
| Post operative bruising | Up to 2 weeks post blepharoplasty surgery | Bruising will be assessed on a 1-5 scale with the higher score indicating more bruising. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post operative swelling | Up to 2 weeks post blepharoplasty surgery | Swelling will be assessed on a 1 to 5 scale with the higher score indicating more swelling |
Countries
United States
Outcome results
None listed