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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RET Treated Eye Plus INhance Group | Experimental | Participants randomized to receive the restorative eye treatment (RET) intervention on either the left or right eyelid will administer the RET cream on the eyelid daily for 4 consecutive weeks prior to scheduled standard of care (SOC) blepharoplasty. After surgery, participants will receive INhance with Trihex technology applied to both eyelids daily for 10 consecutive days post surgery. |
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| RET Untreated eye Plus INhance Group | Experimental | Participants randomized to not receive the RET intervention will not receive any intervention prior to scheduled standard of care (SOC) blepharoplasty. After surgery, participants will receive INhance with Trihex technology applied to both eyelids daily for 10 consecutive days post surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Collagen Content | Assessed from eyelid tissue samples | Up to 1 month prior to blepharoplasty surgery |
| Elastin Content | Assessed from eyelid tissue samples | Up to 1 month prior to blepharoplasty surgery |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wendy W Lee, MD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bascom Palmer Eye Institute, University of Miami | Miami | Florida | 33136 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29663676 | Result | 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. | |
| 32272517 | Result | 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. |
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| ID | Term |
|---|---|
| D003483 | Cutis Laxa |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003240 | Connective Tissue Diseases |
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| INhance with Trihex Technology | Other | INhance will be applied topically to both eyelids once daily for 10 consecutive days after the SOC blepharoplasty surgery. |
|
| 29504212 | Result | 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. |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |