The Effect of Cosmetic Face Care Products on Facial Skin Tone and Spot Brightening

Last updated: November 21, 2024
Sponsor: Unilever R&D
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Cosmetic product C68

Cosmetic product N70

Sunscreen

Clinical Study ID

NCT06640244
HMN-SKA-4185
  • Ages 20-45
  • Female
  • Accepts Healthy Volunteers

Study Summary

This is a single centre, 5-cell, blinded study to evaluate changes in even skin tone, skin glow, facial pigmented spots, and the microbiome of facial skin following the use of cosmetic face care products on the whole face over a 12 week period.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Female adult participants in general good health as determined from a recent medicalhistory.

  • Participants in the age group of 20-45 years (both ages inclusive).

  • Participants having Fitzpatrick photo-type III-V.

  • Participants with at least 3 spots on the cheek either of PIH post acne/age related

  • Participants not presenting any skin condition that may interfere with theassessment for the entire study duration.

  • Participants free of excessive hair, acne, cuts, abrasions, fissures, wounds,lacerations, or any other active skin conditions on the face

  • Participant who agrees not to use any other product/treatment/home remedy/serum ontheir face during the study period other than the study product.

  • Participants who agree to remove all jewellery on/around face (e.g., necklace,earrings, nose ring), during imaging.

  • Participants willing to give a voluntary written informed consent and photographyrelease.

  • Participants willing to abide by and comply with the study protocol.

  • Participants able to read, understand and sign an appropriate informed consent formindicating her willingness to participate.

  • Participants willing and capable to follow the study rules and a fixed schedule.

Exclusion

Exclusion Criteria:

  • Participants who are currently participating in a similar study or have participatedin a similar study in the past 6 weeks.

  • Participants with any other signs of significant local irritation, erythema, or skindisease on skin.

  • Participants having chronic illness or who have undergone major surgery in the lastyear that may be clinically relevant or can impact the results as determined by thedermatologist.

  • Participants undergoing treatment for any skin condition.

  • Participants allergic or sensitive to bar cleansing products, creams/lotions,artificial jewellery or anything else.

  • Participants with self-perceived pimple prone and/or sensitive skin.

  • Participants taking any oral antibiotic medication currently or within the last 8weeks.

  • Participants taking medication continuously/regularly every day such ascorticosteroids or non-steroidal anti-inflammatories, topically for four weeks ororally for eight weeks prior to the study.

  • Female participant pregnant/breast feeding or planning pregnancy during the studyperiod (self-declared)

  • Participants taking product/treatment for any condition which the Investigatorbelieves may influence the interpretation of the data.

  • Participants currently taking any medication, which the investigator believes mayinfluence the interpretation of the data.

Study Design

Total Participants: 250
Treatment Group(s): 6
Primary Treatment: Cosmetic product C68
Phase:
Study Start date:
October 22, 2024
Estimated Completion Date:
March 31, 2025

Study Description

This is a randomized, blinded, 5 cell, full-face study designed to evaluate changes in even skin tone, skin glow, pigmented spots and the surface microbiome of facial skin following the use of one of five cosmetic face care products. This study will accept up to 50 participants per cell (250 participants overall) who meet the inclusion/exclusion criteria to ensure that at least 40 participants per cell complete the study. Participants will be randomised to receive one of the five cosmetic face care products which will be applied to the whole face using a defined protocol.

If accepted onto the study, all participants will be provided with a marketed face wash to use for one week prior to the baseline visit and throughout the whole study.

Visual and instrumental assessments of skin colour, skin glow and even tone will be conducted throughout the duration of the study (12 weeks product use and 6 weeks regression). Non-invasive skin surface samples will be collected at several timepoints for evaluation of the skin microbiome.

Connect with a study center

  • MS Clinical Research Pvt Ltd

    Bangalore, 560008
    India

    Active - Recruiting

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