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| Name | Class |
|---|---|
| MS Clinical Research Pvt. Ltd | UNKNOWN |
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This is a single centre, single cell, blinded study designed to evaluate the effect of 5 cosmetic products on skin brightening, skin hydration and skin barrier function of the volar forearm after controlled UV exposure as compared to baseline and a no-treatment control.
This is a single centre, single cell, blinded study designed to evaluate the effect of cosmetic products on skin brightening, skin hydration and skin barrier function of the volar forearm after controlled UV exposure. This study will accept 34 participants who meet the inclusion and exclusion criteria. Participants will test all 5 products and a no-treatment control, which will be applied twice daily for 6 weeks to pre-defined test sites on their volar forearms.
UV exposure will be conducted using a SOL UV solar simulator (300 - 1200nm; dose level 6 joules/cm2) at various time points during weeks 2 - 5 of the study.
Instrumental assessments of skin brightening, skin hydration and skin barrier function will be conducted at regular intervals throughout the whole study. Non-invasive samples of the stratum corneum will be collected at several timepoints during the study to evaluate biomarkers of skin brightening.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cosmetic product M68 | Experimental | Cosmetic product to be applied twice daily 6 days a week (except on measurement days, when it will be applied once) for the duration of the study. |
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| Cosmetic product Z15 | Experimental | Cosmetic product to be applied twice daily 6 days a week (except on measurement days, when it will be applied once) for the duration of the study. |
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| Cosmetic product R52 | Experimental | Cosmetic product to be applied twice daily 6 days a week (except on measurement days, when it will be applied once) for the duration of the study. |
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| Cosmetic product J61 | Experimental | Cosmetic product to be applied twice daily 6 days a week (except on measurement days, when it will be applied once) for the duration of the study. |
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| Cosmetic product U36 | Experimental | Cosmetic product to be applied twice daily 6 days a week (except on measurement days, when it will be applied once) for the duration of the study. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cosmetic product M68 | Other | Cosmetic skin brightening product to be applied to defined test site |
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| Measure | Description | Time Frame |
|---|---|---|
| L* measured using CM2600D | L* (Luminance) - represents lightness/darkness values of luminosity indices (total quantity of light reflected). L* is measured using spectrophotometer CM2600D, which measures the spectral reflectance in the visible wavelength range of 400nm to 700nm as the ratio of the power of the net total reflected light over total incident light. The colour values of L*a*b* are calculated from the spectral reflectance.
| 0 - 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| a* measured using CM2600D | a* (Red/green component of CIELAB colour space). a* represents colour ranging from red to green - positive values are red; negative values are green. a* is measured using a spectrophotometer CM2600D, which measures the spectral reflectance in the visible wavelength range of 400nm to 700nm as the ratio of the power of the net total reflected light over total incident light. The colour values of L*a*b* are calculated from the spectral reflectance.
|
| Measure | Description | Time Frame |
|---|---|---|
| Stratum corneum biomarkers of skin brightening | Biomarkers associated with skin brightening will be measured from non-invasive D-Squame tape-strip samples of the stratum corneum. Up to 15 sequential tape strips will be collected. The following biomarkers will be analysed using ELISA: Filaggrin: measure of skin barrier. ng/ml. Efficacy: higher is better. IL1a: measure of inflammation. pg/ml. Efficacy: lower is better. IL1RA: measure of inflammation. pg/ml. Efficacy: lower is better. Catalase: measure of antioxidant effect. pg/ml. Efficacy: higher is better. Total antioxidant. mmol/L. Efficacy: higher is better. Total protein will also be measured. Additional biomarkers related to the objectives may also be measured. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr Mukta Sachdev, MD | Contact | +91 8040917243 | mukta.sachdev@msclinical.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MS Clinical Research Pvt Ltd | Bangalore | Karnataka | 560008 | India |
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Each participant will receive all study products.
| No treatment control | No Intervention | No treatment control |
| Cosmetic product Z15 | Other | Cosmetic skin brightening product to be applied to defined test site |
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| Cosmetic product R52 | Other | Cosmetic skin brightening product to be applied to defined test site |
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| Cosmetic product J61 | Other | Cosmetic skin brightening product to be applied to defined test site |
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| Cosmetic product U36 | Other | Cosmetic skin brightening product to be applied to defined test site |
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| 0 - 6 weeks |
| Skin hydration measured using Corneometer CM825 | The corneometer (CM825) indirectly measures the skin's hydration as a change in capacitance of the stratum corneum.
| 0 - 6 weeks |
| Skin barrier function (Trans-Epidermal Water Loss [TEWL]) measured using Tewameter TM300 | Skin barrier function (TEWL) is measured using the Tewameter TM300.
| 0 - 6 weeks |
| 0 - 6 weeks |