The Effect of Cosmetic Products on Skin Brightening

NCT06899321 | Not Yet Recruiting

• 1 other identifier: SKN-SKA-4328
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Skin Brightening

Outcome Measures

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

  0 - 6 weeks

Secondary Outcomes (3)

• a* measured using CM2600D

  0 - 6 weeks

• Skin hydration measured using Corneometer CM825

  0 - 6 weeks

• Skin barrier function (Trans-Epidermal Water Loss [TEWL]) measured using Tewameter TM300

  0 - 6 weeks

Other Outcomes (1)

• Stratum corneum biomarkers of skin brightening

  0 - 6 weeks

Study Arms (6)

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.

Other: Cosmetic product M68

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.

Other: Cosmetic product Z15

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.

Other: Cosmetic product R52

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.

Other: Cosmetic product J61

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.

Other: Cosmetic product U36

No treatment control

NO INTERVENTION

No treatment control

Interventions

Cosmetic product M68 OTHER

Cosmetic skin brightening product to be applied to defined test site

Cosmetic product M68

Cosmetic product Z15 OTHER

Cosmetic skin brightening product to be applied to defined test site

Cosmetic product Z15

Cosmetic product R52 OTHER

Cosmetic skin brightening product to be applied to defined test site

Cosmetic product R52

Cosmetic product J61 OTHER

Cosmetic skin brightening product to be applied to defined test site

Cosmetic product J61

Cosmetic product U36 OTHER

Cosmetic skin brightening product to be applied to defined test site

Cosmetic product U36

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Unilever R&D: lead
• MS Clinical Research Pvt. Ltd: collaborator

Study Sites (1)

MS Clinical Research Pvt Ltd

Bangalore, Karnataka, 560008, India

Location

Central Study Contacts

Dr Mukta Sachdev, MD

CONTACT

+91 8040917243; mukta.sachdev@msclinical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Each participant will receive all study products.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2025
• First Posted: March 27, 2025
• Study Start: March 1, 2025
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: March 27, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)