- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06640244
The Effect of Cosmetic Face Care Products on Facial Skin Tone and Spot Brightening
A Clinical Study to Evaluate the Efficacy of Prototypes for Improvement in Skin Tone and Spot Brightening in a Full-Face Study Design
Study Overview
Status
Conditions
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Bangalore, India, 560008
- MS Clinical Research Pvt Ltd
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Cosmetic product G18
Cosmetic face care product to be used twice daily on the whole face for 12 weeks.
|
To be used by all participants throughout the study
Cosmetic face care product
|
|
Experimental: Cosmetic product N70
Cosmetic face care product to be used twice daily on the whole face for 12 weeks.
|
To be used by all participants throughout the study
Cosmetic face care product
|
|
Experimental: Cosmetic product D79
Cosmetic face care product to be used twice daily on the whole face for 12 weeks.
|
To be used by all participants throughout the study
Cosmetic face care product
|
|
Experimental: Cosmetic product E84
Cosmetic face care product to be used twice daily on the whole face for 12 weeks.
|
To be used by all participants throughout the study
Cosmetic face care product
|
|
Experimental: Cosmetic product C68
Cosmetic face care product to be used twice daily on the whole face for 12 weeks.
|
To be used by all participants throughout the study
Cosmetic face care product
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Visual assessment of skin colour
Time Frame: 0-12 weeks + 6 weeks regression
|
0-12 weeks + 6 weeks regression
|
|
Instrumental assessment of skin colour
Time Frame: 0-12 weeks + 6 weeks regression
|
0-12 weeks + 6 weeks regression
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Changes in skin surface microbiome
Time Frame: 0-12 weeks + 6 weeks regression
|
0-12 weeks + 6 weeks regression
|
Other Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Self assessment questionnaires
Time Frame: 0-12 weeks + 6 weeks regression
|
0-12 weeks + 6 weeks regression
|
|
Visual assessment of facial skin glow and radiance.
Time Frame: 0-12 weeks + 6 weeks regression
|
0-12 weeks + 6 weeks regression
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HMN-SKA-4185
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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