The Effects of Zinc Di-(Dibutyryl Lisinate) on Skin Health and the Skin Microbiome in Photoaged Skin

October 17, 2023 updated by: Integrative Skin Science and Research

Prospective Randomized Vehicle-Controlled Double-Blind Assessment of the Effects of Zinc Di-(Dibutyryl Lisinate) on Skin Biophysical Properties and the Skin Microbiome in Photoaged Skin

This study is a double-blind randomized vehicle-controlled study assessing how Zinc Di-(dibutyryl lisinate) (Z-DBL) influences skin biophysical measures such as skin hydration, transepidermal water loss, and elasticity, as well as its effects on the skin microbiome of photoaged skin.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Females between the ages of 40 years of age until 60 years of age
  • Participants must have facial fine lines and wrinkles
  • Subjects must minimize sun exposure
  • Subjects must avoid professional or facial spa procedures during the study

Exclusion Criteria:

  • Individuals who are pregnant or breastfeeding.
  • Prisoners.
  • Adults unable to consent.
  • Those who are unwilling to discontinue topical hydroquinone, retinoids, bakuchiol, vitamin C, or acetyl zingerone containing products for two weeks to meet the washout criteria prior to enrolling.
  • Those who are unwilling to discontinue topical antibiotics and benzoyl peroxide for two weeks to meet the washout criteria prior to enrolling.
  • Those who have been on an oral antibiotic within 1 month prior to enrolling.
  • Subjects with any of the following facial cosmetic treatments in the past 3 months or those who are unwilling to withhold the following facial cosmetic treatments during the study including botulinum toxin, injectable fillers, microdermabrasion, intense pulsed light (IPL), peels, laser treatments, acid treatments, facial plastic surgery, or any other medical treatment administered by a physician or skin care professional which is designed to improve the appearance of facial skin.
  • Those who are unwilling to discontinue all facial topical products except the product provided in the study.
  • Individuals who have changed any of their hormonal based contraception within 3. months prior to joining the study.
  • Current tobacco smoker or a tobacco smoking history of greater than 10 pack-years.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Topical Vehicle + Zinc Di-(dibutyryl lisinate)
Topical cream containing Zinc Di-(dibutyryl listinate)
Other: Topical Vehicle + Zinc Di-(dibutyryl lisinate)
Instructions: Apply to the entire face twice daily - morning and evening
Placebo Comparator: Topical Vehicle
Topical cream
Other: Topical Vehicle
Instructions: Apply to the entire face twice daily - morning and evening

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in image analysis based pigment intensity
Time Frame: 8 weeks
Facial photographs will be analyzed for pigment intensity for the face after the photographs are obtained and analyzed utilizing the BTBP 3D Clarity Pro Facial Modeling and Analysis System (Brigh-Tex BioPhotonics, San Jose, CA, USA). The pigment intensity will be measured as a relative change from baseline and is a dimensionless and normalized measure.
8 weeks
Skin Hydration
Time Frame: 8 weeks
The skin capacitance will be measured with a handheld non-invasive device (Skin MoistureMeterSC, Delfin Technologies Ltd.). The measurement is in arbitrary units per manufacturer.
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in image analysis based wrinkle severity
Time Frame: 8 weeks
Facial photographs will be obtained and analyzed utilizing the BTBP 3D Clarity Pro Facial Modeling and Analysis System (Brigh-Tex BioPhotonics, San Jose, CA, USA). The measurement will analyze wrinkle severity that is a measure of both the wrinkle depth and width and will be reported as a relative change from baseline.
8 weeks
Shifts in the skin microbiome diversity
Time Frame: 8 weeks
Whole genome sequencing of the skin microbiome
8 weeks
Changes in skin barrier biomarkers like filaggrin
Time Frame: 8 weeks
Measured using D-squame tape strips (CuDerm LLC.)
8 weeks
Product tolerability
Time Frame: 8 weeks
Assessed with the use of a tolerability questionnaire to be completed by participants. Tolerability will be measured by rating symptoms such as burning, stinging, and scaling.
8 weeks
Change in skin elasticity
Time Frame: 8 weeks
Skin elasticity measured with a handheld non-invasive device (Elastimeter, Delfin Technologies Ltd.)
8 weeks
Change in skin transepidermal water loss
Time Frame: 8 weeks
Skin transepidermal water loss measured with a handheld non-invasive device (Vapometer, Delfin Technologies Ltd.)
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Integrative Skin Science and Research

Collaborators

Sytheon Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 15, 2023

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

October 12, 2023

First Submitted That Met QC Criteria

October 17, 2023

First Posted (Actual)

October 24, 2023

Study Record Updates

Last Update Posted (Actual)

October 24, 2023

Last Update Submitted That Met QC Criteria

October 17, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • i23-08-ZBL-SYTH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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