Evaluating the effects of cosmetic face care products on skin tone and pigmentation
A Clinical Study to Evaluate the Efficacy of Prototypes for Improvement in Skin Tone and Spot Brightening in a Full-Face Study Design
This study is testing five different cosmetic face care products to see if they can improve skin tone and reduce pigmentation in people over 12 weeks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 20 Years to 45 Years |
| Sex | Female |
| Sponsor | Unilever R&D Industry-sponsored |
| Locations | 1 site (Bangalore) |
| Trial ID | NCT06640244 on ClinicalTrials.gov |
What this trial studies
This study is a randomized, blinded, 5-cell trial designed to assess the impact of five different cosmetic face care products on facial skin tone, glow, and pigmented spots over a 12-week period. A total of 250 participants will be enrolled, with each participant applying one of the products to their entire face according to a defined protocol. Visual and instrumental assessments will be conducted to measure changes in skin characteristics, and non-invasive samples will be collected to evaluate the skin microbiome at various time points. Participants will also use a marketed face wash for one week prior to the baseline visit and throughout the study.
Who should consider this trial
Good fit: Ideal candidates are healthy adult females aged 20-45 with specific skin types and at least three pigmented spots on their cheeks.
Not a fit: Patients with active skin conditions or those using other facial products during the study may not benefit from this trial.
Why it matters
Potential benefit: If successful, this study could lead to improved cosmetic products that enhance skin tone and reduce pigmentation issues for patients.
How similar studies have performed: While similar studies have explored cosmetic interventions, this specific approach to evaluating multiple products in a controlled setting is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Female adult participants in general good health as determined from a recent medical history. * 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 the assessment 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 on their 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 photography release. * Participants willing to abide by and comply with the study protocol. * Participants able to read, understand and sign an appropriate informed consent form indicating her willingness to participate. * Participants willing and capable to follow the study rules and a fixed schedule. Exclusion Criteria: * Participants who are currently participating in a similar study or have participated in a similar study in the past 6 weeks. * Participants with any other signs of significant local irritation, erythema, or skin disease on skin. * Participants having chronic illness or who have undergone major surgery in the last year that may be clinically relevant or can impact the results as determined by the dermatologist. * 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 8 weeks. * Participants taking medication continuously/regularly every day such as corticosteroids or non-steroidal anti-inflammatories, topically for four weeks or orally for eight weeks prior to the study. * Female participant pregnant/breast feeding or planning pregnancy during the study period (self-declared) * Participants taking product/treatment for any condition which the Investigator believes may influence the interpretation of the data. * Participants currently taking any medication, which the investigator believes may influence the interpretation of the data.
Where this trial is running
Bangalore
- MS Clinical Research Pvt Ltd — Bangalore, India (Recruiting)
Study contacts
- Study coordinator: Dr Mukta Sachdev, MD
- Email: mukta.sachdev@msclinical.com
- Phone: +91 8040917243
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.