Clinical trial NCT06096649: The Effects of Zinc Di-(Dibutyryl Lisinate) on Skin Health and the Skin Microbiome in Photoaged Skin
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Photoaging
Keywords: skin microbiome
skin biophysical properties
photoaging
zinc di-(dibutyryl lisinate)
Lead sponsor: Integrative Skin Science and Research
Sponsor class: INDUSTRY
Collaborators: name: Sytheon Ltd.
First posted: 2023-10-24
Enrollment: 46
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Zinc Di-(dibutyryl lisinate) vs Vehicle
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in image analysis based pigment intensity
timeFrame: 8 weeks
measure: Skin Hydration
timeFrame: 8 weeks
Secondary outcomes:
measure: Change in image analysis based wrinkle severity
timeFrame: 8 weeks
measure: Shifts in the skin microbiome diversity
timeFrame: 8 weeks
measure: Changes in skin barrier biomarkers like filaggrin
timeFrame: 8 weeks
measure: Product tolerability
timeFrame: 8 weeks
measure: Change in skin elasticity
timeFrame: 8 weeks
measure: Change in skin transepidermal water loss
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Integrative Skin Science and Research
state: California
Study officials:
References: