The Effect of Cosmetic Products on Skin Brightening

A Clinical Study to Evaluate Test Products for Skin Brightening Benefit Under Controlled UV Exposure, in a 6-week Study Design

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Skin Brightening
• Intervention / Treatment: Other: Cosmetic product M68; Other: Cosmetic product Z15; Other: Cosmetic product R52; Other: Cosmetic product J61; Other: Cosmetic product U36

Detailed Description

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
• Enrollment (Estimated): 34
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dr Mukta Sachdev, MD; Phone Number: +91 8040917243; Email: mukta.sachdev@msclinical.com

Study Locations

• India
  • Karnataka
    • Bangalore, Karnataka, India, 560008
      • MS Clinical Research Pvt Ltd
      • Contact: Dr Mukta Sachdev, MD; Phone Number: +91 80 40917243; Email: mukta.sachdev@msclinical.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.
• Participants having skin photo-type IV and V.
• Participants with Spectrophotometer L* value- 45 to 55 (both values included) on the identified test sites on the volar forearm.
• Participants having uniform skin color and no sunburn/ erythema on the test sites.
• Participants who do not have very dry or scaly skin, uneven skin tone on their volar forearms or no other signs of significant local irritation or skin disease like psoriasis.
• Participants who agree to refrain from using pumice stone, scrubber while bathing during the study.
• Participants who are willing to avoid direct sun exposure to the test sites.
• Participants who have not participated in any clinical product evaluation test within past 1 month.
• Participants able to read and sign an appropriate informed consent form indicating her willingness to participate and agree to come for regular study visits.
• Participants willing to abide by and comply with the study protocol.
• Participants willing to use umbrella & wear full covered attire if she has to go in sun.
• Participants who are willing not to participate in any other clinical study during participation in the current study.

Exclusion Criteria:

• 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.
• Participants having active skin diseases which will interfere with the test readings.
• Participants on oral and topical medications (e.g Steroids, anti-oxidant, antibiotics) which will compromise the study.
• Systemic treatment which may modify the cutaneous state on the day of inclusion or in the previous 30 days, including retinoid therapy.
• Participants who are pregnant, lactating or nursing.
• Intense sun exposure/ photo allergenicity/toxicity.
• Chronic illness which may influence the cutaneous state.
• Participants participating in any other cosmetic or therapeutic trial.
• Participants with any underlying uncontrolled medical illness including diabetes mellitus, hypertension, liver disease or history of alcoholism, HIV, hepatitis, or any other serious medical illness that will pose a health risk due to study participation as per investigator's discretion.
• For female participants only: be pregnant, planning pregnancy or lactating/nursing. Urine pregnancy testing (UPT) will be performed at the time of screening.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: No treatment control
Experimental: 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 M68; Cosmetic skin brightening product to be applied to defined test site
Experimental: 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 Z15; Cosmetic skin brightening product to be applied to defined test site
Experimental: 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 R52; Cosmetic skin brightening product to be applied to defined test site
Experimental: 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 J61; Cosmetic skin brightening product to be applied to defined test site
Experimental: Cosmetic product U36; 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; Cosmetic skin brightening product to be applied to defined test site

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.; Manufacturer Name: Konica Minolta; Measurement Range: L* 0 - 100; Efficacy Direction of L*: Higher is better	0 - 6 weeks

Secondary Outcome Measures

Outcome Measure	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.; Manufacturer Name: Konica Minolta; Measurement Range: a* -128 to 127; Efficacy Direction of a*: +a is redder, -a is greener	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	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	0 - 6 weeks

Other Outcome Measures

Outcome Measure	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.	0 - 6 weeks

Collaborators and Investigators

• Sponsor: Unilever R&D
• Collaborators: MS Clinical Research Pvt. Ltd

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2025
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: March 11, 2025
• First Submitted That Met QC Criteria: March 20, 2025
• First Posted (Actual): March 27, 2025

Study Record Updates

• Last Update Posted (Actual): March 27, 2025
• Last Update Submitted That Met QC Criteria: March 20, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: SKN-SKA-4328

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No