Eyelid DermatochalasisNCT05007288
Restorative Eye Treatment and INhance in Upper Eyelid Blepharoplasty Surgery
A study testing Restorative Eye Treatment (RET) cream and INhance with Trihex Technology in people with Eyelid Dermatochalasis and Dermatochalasis, run by University of Miami at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Eyelid Dermatochalasis, Dermatochalasis
- What is being tested?
- Restorative Eye Treatment (RET) cream and INhance with Trihex Technology
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2020to 30 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
- Participants who have demonstrated a previous hypersensitivity reaction to any of the ingredients of the study products.
- Participants that have been using topical products around their upper or lower eyes within 30 days.
- Participants who are, in the opinion of the investigator, unwilling or unable to comply with the requirements of the protocol.
- Pregnant or lactating participants will be excluded, as well as participants planning on becoming pregnant during the study duration.
- Participants with recent excessive exposure to sunlight or artificial UV light (e.g.: use of tanning beds/booths and/or sunbathing).
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- A participant with a history of keloids or hypertrophic scars.
- Participants known to harbour a blood borne disease (e.g. Hepatitis A Virus (HAV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV ), HIV)
- Special populations: Prisoners, Pregnant women, Adults unable to consent, Individuals who are not yet adults.
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Bascom Palmer Eye Institute, University of Miami
Miami, Florida, 33136
About this study
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
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.
- Conditions
- Eyelid Dermatochalasis, Dermatochalasis
- Being tested
- Restorative Eye Treatment (RET) cream, INhance with Trihex Technology
- Keywords
- Blepharoplasty
- Medical subject headings
- Cutis Laxa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Restorative Eye Treatment (RET) creamOther
RET cream will be applied topically to either the left of right eyelid once daily for 4 consecutive weeks.
INhance with Trihex TechnologyOther
INhance will be applied topically to both eyelids once daily for 10 consecutive days after the SOC blepharoplasty surgery.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Restorative Eye Treatment (RET) cream; Other: INhance with Trihex Technology |
| 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. Receives: Other: INhance with Trihex Technology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collagen Content
Assessed from eyelid tissue samples
Measured: Up to 1 month prior to blepharoplasty surgery
Elastin Content
Assessed from eyelid tissue samples
Measured: 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.
Measured: Up to 2 weeks post blepharoplasty surgery
Secondary outcomes (1)
Post operative swelling
Swelling will be assessed on a 1 to 5 scale with the higher score indicating more swelling
Measured: Up to 2 weeks post blepharoplasty surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2021
- Study start1 May 2020
- Primary completion30 Apr 2022
- Study completion30 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Eyelid DermatochalasisStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wendy Lee, University of Miami
- Investigators
- Wendy W Lee, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05007288
- Sponsor's protocol ID
- 20200939
- Status last verified
- Apr 2023
- First submitted
- 11 May 2021
- Last updated
- 11 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29663676Widgerow 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.
PubMed 32272517Widgerow 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.
PubMed 29504212
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05007288
- Acronym / sponsor ID
- 20200939
- Conditions
- Eyelid Dermatochalasis, Dermatochalasis
- Keywords
- Blepharoplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Jul 2022 (actual)
- First posted
- 16 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RET Treated Eye Plus INhance Group | Experimental | Other: Restorative Eye Treatment (RET) cream, Other: INhance with Trihex TechnologyParticipants 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. |
| RET Untreated eye Plus INhance Group | Experimental | Other: INhance with Trihex TechnologyParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
- Participants who have demonstrated a previous hypersensitivity reaction to any of the ingredients of the study products.
- Participants that have been using topical products around their upper or lower eyes within 30 days.
- Participants who are, in the opinion of the investigator, unwilling or unable to comply with the requirements of the protocol.
- Pregnant or lactating participants will be excluded, as well as participants planning on becoming pregnant during the study duration.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Restorative Eye Treatment (RET) creamRET cream will be applied topically to either the left of right eyelid once daily for 4 consecutive weeks. | Other | RET Treated Eye Plus INhance Group |
| INhance with Trihex TechnologyINhance will be applied topically to both eyelids once daily for 10 consecutive days after the SOC blepharoplasty surgery. | Other | RET Treated Eye Plus INhance Group, RET Untreated eye Plus INhance Group |
Primary outcome
Collagen Content
Time frame: Up to 1 month prior to blepharoplasty surgery
Assessed from eyelid tissue samples
Elastin Content
Time frame: Up to 1 month prior to blepharoplasty surgery
Assessed from eyelid tissue samples
Post operative bruising
Time frame: Up to 2 weeks post blepharoplasty surgery
Bruising will be assessed on a 1-5 scale with the higher score indicating more bruising.
1 secondary outcome
Post operative swelling
Time frame: Up to 2 weeks post blepharoplasty surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2023.
- Results publication: PubMed 29663676Reivitis 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.
- Results publication: PubMed 32272517Widgerow 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.
- Results publication: PubMed 29504212Widgerow 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wendy W Lee, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Restorative Eye Treatment (RET) cream and INhance with Trihex Technology in people with Eyelid Dermatochalasis and Dermatochalasis, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Collagen Content (time frame: Up to 1 month prior to blepharoplasty surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05007288, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2023.