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

Not Applicable

Not yet recruiting

• Conditions: Photoaging
• Interventions: Other: Topical Vehicle; Other: Topical Vehicle + Zinc Di-(dibutyryl lisinate)

• Registration Number: NCT06096649
• Lead Sponsor: Integrative Skin Science and Research

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-10
• Study First Submitted: 2023-10-12
• Study Start: 2023-10-15
• Study First Submitted QC: 2023-10-17
• Last Update Submitted: 2023-10-17
• Study First Posted: 2023-10-24
• Last Update Posted: 2023-10-24
• Primary Completion: 2024-09
• Study Completion: 2024-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 46

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Topical Vehicle	Topical Vehicle	Topical cream
Topical Vehicle + Zinc Di-(dibutyryl lisinate)	Topical Vehicle + Zinc Di-(dibutyryl lisinate)	Topical cream containing Zinc Di-(dibutyryl listinate)

Primary Outcome Measures

Name	Time	Method
Skin Hydration	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.
Change in image analysis based pigment intensity	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.

Secondary Outcome Measures

Name	Time	Method
Shifts in the skin microbiome diversity	8 weeks	Whole genome sequencing of the skin microbiome
Change in skin transepidermal water loss	8 weeks	Skin transepidermal water loss measured with a handheld non-invasive device (Vapometer, Delfin Technologies Ltd.)
Changes in skin barrier biomarkers like filaggrin	8 weeks	Measured using D-squame tape strips (CuDerm LLC.)
Change in image analysis based wrinkle severity	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.
Product tolerability	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.
Change in skin elasticity	8 weeks	Skin elasticity measured with a handheld non-invasive device (Elastimeter, Delfin Technologies Ltd.)

Trial Locations

Locations (1)

Integrative Skin Science and Research; 🇺🇸 Sacramento, California, United States