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| Name | Class |
|---|---|
| Verdure Sciences | INDUSTRY |
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Recent research has reported that the maple leaf extract exhibits anti-aging effects by inhibiting elastase activity, thereby preventing the breakdown of elastin and interfering with the formation of wrinkles. Red maple leaf extract contains phenolic compounds known as glucitol-core-containing gallotannins (GCGs) which help reduce the appearance of wrinkles and may decrease skin inflammation, dark spots and pigmentation. The objective of this study is to examine the effects of topical Maplifa on the cosmetic appearance of facial lines, redness and skin tone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| vehicle only-placebo | Placebo Comparator | Vehicle cream base containing no maple leaf extract to be applied twice daily to the face |
|
| 1% red maple leaf extract | Experimental | lotion preparation with 1% red maple leaf extract to be applied twice daily to the face |
|
| 5% red maple leaf extract | Experimental | lotion preparation with 5% red maple leaf extract to be applied twice daily to the face |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1% red maple leaf extract in cream base | Combination Product | 1% red maple leaf extract is combined in a cream base |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pigmentation on SkinColorCatch | Assessment of pigmentation based on melanin measurement on SkinColorCatch (arbitrary units set by technology) | At 4 weeks (end of study) |
| Clinical grading of Hyperpigmentation | Assessment of hyperpigmentation based on clinical grading (categories 0-5) by blinded evaluator | At 4 weeks (end of study) |
| Erythema on SkinColorCatch | Assessment of erythema based on SkinColorCatch (arbitrary units set by technology) | At 4 weeks (end of study) |
| Clinical grading of Erythema | Assessment of erythema based on clinical grading (categories 0-5) by blinded evaluator | At 4 weeks (end of study) |
| Measure | Description | Time Frame |
|---|---|---|
| Centrofacial redness | Image-based analysis of redness [Skinmap level Degree of Intensity (%) on BTBP Clarity Research 3D System] | At 4 weeks (end of study) |
| Appearance of wrinkles | Image-based analysis of wrinkles (Average severity - unitless on BTBP Clarity Research 3D System) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Raja K Sivamani, MD | Integrative Skin Science and Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Integrative Skin Science and Research | Sacramento | California | 95815 | United States |
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| ID | Term |
|---|---|
| D017495 | Hyperpigmentation |
| ID | Term |
|---|---|
| D010859 | Pigmentation Disorders |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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Healthy females ages 30-70 with Fitzpatrick skin type I-IV
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| 5% red maple leaf extract | Combination Product | 5% red maple leaf extract is combined in a cream base |
|
| vehicle | Combination Product | vehicle cream base only |
|
| At 4 weeks (end of study) |