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| Name | Class |
|---|---|
| Sytheon Ltd. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Topical Vehicle + Zinc Di-(dibutyryl lisinate) | Experimental | Topical cream containing Zinc Di-(dibutyryl listinate) |
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| Topical Vehicle | Placebo Comparator | Topical cream |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topical Vehicle + Zinc Di-(dibutyryl lisinate) | Other | Instructions: Apply to the entire face twice daily - morning and evening |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Raja K. Sivamani, MD | Contact | 916-524-1216 | research@integrativeskinresearch.com | |
| Nasima Afzal | Contact | nasima@integrativeskinresearchc.om |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Integrative Skin Science and Research | Sacramento | California | 95819 | United States |
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Zinc Di-(dibutyryl lisinate) vs Vehicle
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| Topical Vehicle | Other | Instructions: Apply to the entire face twice daily - morning and evening |
|
| Shifts in the skin microbiome diversity | Whole genome sequencing of the skin microbiome | 8 weeks |
| Changes in skin barrier biomarkers like filaggrin | Measured using D-squame tape strips (CuDerm LLC.) | 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. | 8 weeks |
| Change in skin elasticity | Skin elasticity measured with a handheld non-invasive device (Elastimeter, Delfin Technologies Ltd.) | 8 weeks |
| Change in skin transepidermal water loss | Skin transepidermal water loss measured with a handheld non-invasive device (Vapometer, Delfin Technologies Ltd.) | 8 weeks |