An interventional study of Cosmetic product M68 and Cosmetic product Z15 in Skin Brightening, sponsored by Unilever R&D. Not yet recruiting at 1 site in India. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-27.
Sponsored by Unilever R&D (part of Unilever) · Not applicable, Interventional, and Prevention
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.
Unilever R&D is the lead sponsor of 71 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: Cosmetic product M68
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.
Other: Cosmetic product Z15
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.
Other: Cosmetic product R52
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.
Other: Cosmetic product J61
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.
Other: Cosmetic product U36
No treatment control
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
Cosmetic skin brightening product to be applied to defined test site
Cosmetic skin brightening product to be applied to defined test site
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
Time frame: 0 - 6 weeks
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
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Mar 2025; primary completion for May 2025, 2 months later.
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This study is not yet recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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