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| Name | Class |
|---|---|
| MS Clinical Research Pvt. Ltd | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cosmetic product G18 | Experimental | Cosmetic face care product to be used twice daily on the whole face for 12 weeks. |
|
| Cosmetic product N70 | Experimental | Cosmetic face care product to be used twice daily on the whole face for 12 weeks. |
|
| Cosmetic product D79 | Experimental | Cosmetic face care product to be used twice daily on the whole face for 12 weeks. |
|
| Cosmetic product E84 | Experimental | Cosmetic face care product to be used twice daily on the whole face for 12 weeks. |
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| Cosmetic product C68 | Experimental | Cosmetic face care product to be used twice daily on the whole face for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sunscreen | Other | To be used by all participants throughout the study |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual assessment of skin colour | 0-12 weeks + 6 weeks regression | |
| Instrumental assessment of skin colour | 0-12 weeks + 6 weeks regression |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in skin surface microbiome | 0-12 weeks + 6 weeks regression |
| Measure | Description | Time Frame |
|---|---|---|
| Self assessment questionnaires | 0-12 weeks + 6 weeks regression | |
| Visual assessment of facial skin glow and radiance. | 0-12 weeks + 6 weeks regression |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MS Clinical Research Pvt Ltd | Bangalore | 560008 | India |
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| ID | Term |
|---|---|
| D013473 | Sunscreening Agents |
| ID | Term |
|---|---|
| D011837 | Radiation-Protective Agents |
| D020011 | Protective Agents |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
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Statistician
| Cosmetic product G18 | Other | Cosmetic face care product |
|
| Cosmetic product N70 | Other | Cosmetic face care product |
|
| Cosmetic product D79 | Other | Cosmetic face care product |
|
| Cosmetic product E84 | Other | Cosmetic face care product |
|
| Cosmetic product C68 | Other | Cosmetic face care product |
|
| D020164 | Chemical Actions and Uses |
| D003879 | Dermatologic Agents |
| D045506 | Therapeutic Uses |
| D003358 | Cosmetics |
| D020313 | Specialty Uses of Chemicals |