PhotoagingNCT06096649
The Effects of Zinc Di-(Dibutyryl Lisinate) on Skin Health and the Skin Microbiome in Photoaged Skin
A study of Photoaging, run by Integrative Skin Science and Research at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 40 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Photoaging
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2023to Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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 locations and contacts
1 site in 1 country.
Nasima Afzal contact
United States1 site
Integrative Skin Science and Research
Sacramento, California, 95819
Mildred Min, 916-750-2463, mildred@integrativeskinresearch.com
About this study
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
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.
- Conditions
- Photoaging
- Being tested
- Topical Vehicle + Zinc Di-(dibutyryl lisinate), Topical Vehicle
- Keywords
- skin microbiome, skin biophysical properties, photoaging, zinc di-(dibutyryl lisinate)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical Vehicle + Zinc Di-(dibutyryl lisinate)Other
Instructions: Apply to the entire face twice daily - morning and evening
Topical VehicleOther
Instructions: Apply to the entire face twice daily - morning and evening
| Study group | Role | What they receive |
|---|---|---|
| Topical Vehicle + Zinc Di-(dibutyryl lisinate) | Experimental | Topical cream containing Zinc Di-(dibutyryl listinate) Receives: Other: Topical Vehicle + Zinc Di-(dibutyryl lisinate) |
| Topical Vehicle | Placebo comparator | Topical cream Receives: Other: Topical Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
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.
Measured: 8 weeks
Secondary outcomes (6)
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.
Measured: 8 weeks
Shifts in the skin microbiome diversity
Whole genome sequencing of the skin microbiome
Measured: 8 weeks
Changes in skin barrier biomarkers like filaggrin
Measured using D-squame tape strips (CuDerm LLC.)
Measured: 8 weeks
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.
Measured: 8 weeks
Change in skin elasticity
Skin elasticity measured with a handheld non-invasive device (Elastimeter, Delfin Technologies Ltd.)
Measured: 8 weeks
Change in skin transepidermal water loss
Skin transepidermal water loss measured with a handheld non-invasive device (Vapometer, Delfin Technologies Ltd.)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2023
- Study start15 Oct 2023 (estimated)
- Primary completionSep 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PhotoagingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Zinc Di-(dibutyryl lisinate) vs Vehicle
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Integrative Skin Science and Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sytheon Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06096649
- Sponsor's protocol ID
- i23-08-ZBL-SYTH
- Status last verified
- Oct 2023
- First submitted
- 12 Oct 2023
- Last updated
- 24 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06096649
- Acronym / sponsor ID
- i23-08-ZBL-SYTH
- Conditions
- Photoaging
- Keywords
- skin microbiome, skin biophysical properties, photoaging, zinc di-(dibutyryl lisinate)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Integrative Skin Science and ResearchIndustry (pharma, biotech, devices)
- Collaborators
- Sytheon Ltd.
- Study start
- 15 Oct 2023 (estimated)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 24 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Zinc Di-(dibutyryl lisinate) vs Vehicle
| Arm | Type | Receives |
|---|---|---|
| Topical Vehicle + Zinc Di-(dibutyryl lisinate) | Experimental | Other: Topical Vehicle + Zinc Di-(dibutyryl lisinate)Topical cream containing Zinc Di-(dibutyryl listinate) |
| Topical Vehicle | Placebo comparator | Other: Topical VehicleTopical cream |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Topical Vehicle + Zinc Di-(dibutyryl lisinate)Instructions: Apply to the entire face twice daily - morning and evening | Other | Topical Vehicle + Zinc Di-(dibutyryl lisinate) |
| Topical VehicleInstructions: Apply to the entire face twice daily - morning and evening | Other | Topical Vehicle |
Primary outcome
Change in image analysis based pigment intensity
Time frame: 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.
Skin Hydration
Time frame: 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.
6 secondary outcomes
Change in image analysis based wrinkle severity
Time frame: 8 weeks
Shifts in the skin microbiome diversity
Time frame: 8 weeks
Changes in skin barrier biomarkers like filaggrin
Time frame: 8 weeks
Product tolerability
Time frame: 8 weeks
Change in skin elasticity
Time frame: 8 weeks
Change in skin transepidermal water loss
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nasima Afzal contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Photoaging, run by Integrative Skin Science and Research at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Raja K. Sivamani, MD (916-524-1216, research@integrativeskinresearch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in image analysis based pigment intensity (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2023; AzTrials last refreshed its copy on 8 Nov 2026.