Health TrialsbyHealthPanel

The Effect of Cosmetic Products on Skin Brightening

ConditionSkin Brightening
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorUnilever R&D

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Healthy female adult participants in general good health as determined from a recent medical history.

Participants in the age group of 18-45 years as on the day of enrolment (both ages inclusive).

Participants having very little hair, no burns, no cut/abrasion; no moles/tattoo/birth marks/burn marks on the test sites/areas as identified on screening.

Participants with long and broad forearms.

Disqualifiers

Participants with a known history or present condition of allergic response to any sunscreen products, cosmetic products, bathing soaps, detergent powder or medicine.

Participants who have outdoor job, extremely physical (manual) job which could cause excessive sun exposure or sweating

Participants who are smokers.

Menopausal women.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Cosmetic product M68

    Other intervention

    Cosmetic skin brightening product to be applied to defined test site

  • Cosmetic product Z15

    Other intervention

    Cosmetic skin brightening product to be applied to defined test site

  • Cosmetic product R52

    Other intervention

    Cosmetic skin brightening product to be applied to defined test site

  • Cosmetic product J61

    Other intervention

    Cosmetic skin brightening product to be applied to defined test site

  • Cosmetic product U36

    Other intervention

    Cosmetic skin brightening product to be applied to defined test site

Treatment groups

34 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Cosmetic product M68Experimental treatment 1 intervention
Group B: Cosmetic product Z15Experimental treatment 1 intervention
Group C: Cosmetic product R52Experimental treatment 1 intervention
Group D: Cosmetic product J61Experimental treatment 1 intervention
Group E: Cosmetic product U36Experimental treatment 1 intervention
Group F: No treatment controlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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

Time frame
0 - 6 weeks

Other outcomes

1

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.

Time frame
0 - 6 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Unilever R&D

Lead sponsor

MS Clinical Research Pvt. Ltd

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: