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

NCT ID: NCT06096649

Last Updated: 2023-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-15

Study Completion Date

2024-09-30

Brief Summary

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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

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Conditions

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Photoaging

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Zinc Di-(dibutyryl lisinate) vs Vehicle
Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Topical Vehicle + Zinc Di-(dibutyryl lisinate)

Topical cream containing Zinc Di-(dibutyryl listinate)

Group Type EXPERIMENTAL

Topical Vehicle + Zinc Di-(dibutyryl lisinate)

Intervention Type OTHER

Instructions: Apply to the entire face twice daily - morning and evening

Topical Vehicle

Topical cream

Group Type PLACEBO_COMPARATOR

Topical Vehicle

Intervention Type OTHER

Instructions: Apply to the entire face twice daily - morning and evening

Interventions

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Topical Vehicle + Zinc Di-(dibutyryl lisinate)

Instructions: Apply to the entire face twice daily - morning and evening

Intervention Type OTHER

Topical Vehicle

Instructions: Apply to the entire face twice daily - morning and evening

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Sytheon Ltd.

INDUSTRY

Sponsor Role collaborator

Integrative Skin Science and Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Integrative Skin Science and Research

Sacramento, California, United States

Site Status

Countries

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United States

Central Contacts

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Raja K. Sivamani, MD

Role: CONTACT

916-524-1216

Nasima Afzal

Role: CONTACT

Facility Contacts

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Mildred Min

Role: primary

916-750-2463

Other Identifiers

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i23-08-ZBL-SYTH

Identifier Type: -

Identifier Source: org_study_id

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