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

Integrative Skin Science and Research

Status: Not yet enrolling

Conditions: Photoaging

Treatments: Other: Topical Vehicle + Zinc Di-(dibutyryl lisinate); Other: Topical Vehicle

Study type: Interventional

Funder types: Industry

Identifiers

NCT06096649

i23-08-ZBL-SYTH

Details and patient eligibility

About

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.

Enrollment: 46 estimated patients

Sex: Female

Ages: 40 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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46 participants in 2 patient groups, including a placebo group

Topical Vehicle + Zinc Di-(dibutyryl lisinate)

Experimental group

Description:

Topical cream containing Zinc Di-(dibutyryl listinate)

Treatment:

Other: Topical Vehicle + Zinc Di-(dibutyryl lisinate)

Topical Vehicle

Placebo Comparator group

Description:

Topical cream

Treatment:

Other: Topical Vehicle