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

Photoaging Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06096649
• Other study ID #: i23-08-ZBL-SYTH
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 15, 2023
• Est. completion date: September 2024

Study information

• Verified date: October 2023
• Source: Integrative Skin Science and Research
• Contact: Raja K. Sivamani, MD
• Phone: 916-524-1216
• Email: research[@]integrativeskinresearch.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 46
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Photoaging

Intervention

Other:
• Topical Vehicle + Zinc Di-(dibutyryl lisinate)
Instructions: Apply to the entire face twice daily - morning and evening
• Topical Vehicle
Instructions: Apply to the entire face twice daily - morning and evening

Locations

Country	Name	City	State
United States	Integrative Skin Science and Research	Sacramento	California

Sponsors (2)

Lead Sponsor	Collaborator
Integrative Skin Science and Research	Sytheon Ltd.

Country where clinical trial is conducted

United States, 

Outcome

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