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| Name | Class |
|---|---|
| Validated Claim Support | UNKNOWN |
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The purpose of this study is to assess the efficacy (ability to produce a desired or intended result) of a topical product (applied to the skin) to improve skin lightness, skin condition and appearance (hyperpigmentation [dark spots], brightness/radiance [healthy vibrant appearance], skin texture [smoothness]) on ] the face over a period of eighteen (18) weeks. The data collected may support the company in developing marketing claims for its product.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Product | Experimental |
| |
| Control Product | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Facial Toner | Drug | Brightening Toner |
| |
| Placebo Toner |
| Measure | Description | Time Frame |
|---|---|---|
| Skin Lightness | L* and Individual Typology Angle | 18 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Facial Hyperpigmentation | Analyzed by Expert Grading in a 10-point ordinal scale (0 = positive anchor of uniform, even appearance, and 9 = negative anchor of uneven, discolored, pigmentation present) | 18 weeks |
| Facial Skin Texture |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Validated Claim Support | Teaneck | New Jersey | 07666 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17200942 | Background | Baumann L. Skin ageing and its treatment. J Pathol. 2007 Jan;211(2):241-51. doi: 10.1002/path.2098. | |
| 19889046 | Background | Samson N, Fink B, Matts PJ. Visible skin condition and perception of human facial appearance. Int J Cosmet Sci. 2010 Jun;32(3):167-84. doi: 10.1111/j.1468-2494.2009.00535.x. Epub 2009 Nov 3. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Aug 13, 2025 | Aug 14, 2025 | ICF_000.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 23, 2026 | May 14, 2026 | 1 | ||
| May 22, 2026 |
| ID | Term |
|---|---|
| D017495 | Hyperpigmentation |
| ID | Term |
|---|---|
| D010859 | Pigmentation Disorders |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Other |
Placebo Control Toner |
|
Analyzed by Expert Grading in a 10-point ordinal scale (0 = positive anchor of smooth, even surface appearance, and 9 = negative anchor of rough, uneven surface appearance)
| 18 weeks |
| Facial Brightness/Radiance | Analyzed by Expert Grading in a 10-point ordinal scale (0 = positive anchor of radiant, glowing appearance, and 9 = negative anchor of dull/lackluster) | 18 weeks |
| Volunteer's opinion on product | Subjective Questionnaire | 18 weeks |
| Facial skin changes via images | Photo analysis acquired via Visia CR Imaging | 18 weeks |
| Jun 17, 2026 |
| 2 |