INhance with Trihex Technology for Dermatochalasis

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Bascom Palmer Eye Institute, University of Miami, Miami, FL
Dermatochalasis+2 More
INhance with Trihex Technology - Other
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a product can improve skin quality before and after a surgery.

See full description

Eligible Conditions

  • Dermatochalasis
  • Eyelid Dermatochalasis

Treatment Effectiveness

Study Objectives

This trial is evaluating whether INhance with Trihex Technology will improve 3 primary outcomes and 1 secondary outcome in patients with Dermatochalasis. Measurement will happen over the course of Up to 2 weeks post blepharoplasty surgery.

Month 1
Collagen Content
Elastin Content
Week 2
Post operative bruising
Post operative swelling

Trial Safety

Trial Design

2 Treatment Groups

RET Untreated eye Plus INhance Group
1 of 2
RET Treated Eye Plus INhance Group
1 of 2
Experimental Treatment

This trial requires 10 total participants across 2 different treatment groups

This trial involves 2 different treatments. INhance With Trihex Technology is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

RET Untreated eye Plus INhance Group
Other
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.
RET Treated Eye Plus INhance GroupParticipants 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.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 1 month prior to blepharoplasty surgery
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 1 month prior to blepharoplasty surgery for reporting.

Who is running the study

Principal Investigator
W. L.
Prof. Wendy Lee, Professor of Ophthalmology
University of Miami

Closest Location

Bascom Palmer Eye Institute, University of Miami - Miami, FL

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 7 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
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.

Patient Q&A Section

What causes cutis laxa?

"We have found 3 new causative mutations in the ELN gene and propose for the first time that ELN pathogenic variants are associated with cutis laxa." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating cutis laxa?

"There are a number of treatment options for cutis laxa; however, studies have not been done to determine long-term effectiveness. The use of skin grafts from donor sites which are unaffected by the condition is an option. It is also possible to use silicone elastomers to produce a soft, flexible and durable soft foam. However, this material must be changed every two to five years and is expensive. There are other cosmetic options, such as use of topical medications and laser treatments. These treatments can be used to improve the appearance, and to improve the strength of elastic fibers. They can also reduce scarring." - Anonymous Online Contributor

Unverified Answer

What are common treatments for cutis laxa?

"Oral antibiotics are used to treat cutis laxa with cutaneous fistulas, and topical antibiotics can be used to treat cutis laxa without cutaneous fistulas. Skin excision, in combination with skin grafting is the definitive method to treat cutis laxa." - Anonymous Online Contributor

Unverified Answer

What are the signs of cutis laxa?

"Cutis laxa is characterised by skin folds, folds around the abdomen (sacral) creases and a thickened and wrinkled skin. These symptoms are caused by a loss of collagen in the connective tissues." - Anonymous Online Contributor

Unverified Answer

How many people get cutis laxa a year in the United States?

"There is an average of 0.8 new cases of cutis laxusa per million population per year in the United States. The estimated prevalence of cutis laxa in the US populations is 8.1 in 2000. Subjects who are affected by cutis laxa usually start having symptoms during adulthood. There is no clear pattern to the age of onset of the symptoms." - Anonymous Online Contributor

Unverified Answer

Can cutis laxa be cured?

"In a recent study, findings of this study indicate that most affected patients can be treated successfully with minimal side effects; this is probably due not to the cause of cutis laxa, but rather to the underlying disorder-the autonomic nervous system, which may be the most easily changeable part of the patient's body." - Anonymous Online Contributor

Unverified Answer

What is cutis laxa?

"There is no single "right" or single "wrong" treatment for patients with cutis laxa or atopic dermatitis. A patient's condition and expectations will influence treatment choices. Patients with cutis laxa typically require a combination of treatments, some which have limited efficacy, such as corticosteroids, and some that have proven efficacy, such as isotretinoin, for long-term treatment." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets cutis laxa?

"A high proportion of subjects with cutis laxa have a family history of the disease. The familial penetrance is estimated at 68% in this study. [Cutis laxa is most prevalent in subjects >20 years old." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in inhance with trihex technology for therapeutic use?

"The novel, air-stable, bi-lobal device allows to treat small skin lesions, such as ichthyosis, lichenified skin, psoriasis, and atopic conditions. The 3-fold enhancement in the cutaneous absorption of trihex correlates with the enhanced skin permeability and enhanced absorption of trihex in a mouse model of skin inflammation and psoriasis. Furthermore, in this pilot study, treatment of atopic dermatitis patients using the BID device showed the effectiveness and safety of the BID device in atopic dermatitis treatment." - Anonymous Online Contributor

Unverified Answer

Does cutis laxa run in families?

"Although cutis laxa is a genetic condition, the penetrance of cutis laxa is still relatively high between first-degree relatives. Patients with cutis laxa should be assessed in the context of the family history which may provide insight into the mode of inheritance and help in the genetic counselling of the patient." - Anonymous Online Contributor

Unverified Answer

How serious can cutis laxa be?

"Many patients have symptoms that can preclude them from doing strenuous exercise. Furthermore, many older patients report that they are disabled by cutis laxa. Patients who have low BMI values should be questioned by their physician as to possible exercise limitations." - Anonymous Online Contributor

Unverified Answer

Is inhance with trihex technology safe for people?

"Although the potential effect of inhance on skin barrier function is of concern, there is no evidence that inhance with trihex is associated with increased rates of skin reactions suggestive of cutis laxa." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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