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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
34
Cosmetic skin brightening product to be applied to defined test site
Cosmetic skin brightening product to be applied to defined test site
Cosmetic skin brightening product to be applied to defined test site
MS Clinical Research Pvt Ltd
Bangalore, Karnataka, India
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. * Manufacturer Name: Konica Minolta * Measurement Range: L\* 0 - 100 * Efficacy Direction of L\*: Higher is better
Time frame: 0 - 6 weeks
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. * Manufacturer Name: Konica Minolta * Measurement Range: a\* -128 to 127 * Efficacy Direction of a\*: +a is redder, -a is greener
Time frame: 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. * Manufacturer Name: MPA (Multiprobe Adaptor) unit from C\&K (Courage \& Khazaka) * Depth of measurement approximately 45 μm * Measurement Range: 0 - 120 Arbitrary Units (AU) * Efficacy Direction of Corneometer reading: Higher is better
Time frame: 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. * Manufacturer Name: MPA (Multiprobe Adaptor) unit from C\&K (Courage Khazaka) * Measurement Range: 0 - 250 g/m²/h * Efficacy Direction of TEWL reading: Lower is better
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Cosmetic skin brightening product to be applied to defined test site
Cosmetic skin brightening product to be applied to defined test site
Time frame: 0 - 6 weeks