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Investigate the topical use of almond oil, almond oil augmented with 0.5% vitamin E, 0.025% tretinoin oil augmented with castor oil on the appearance of facial fine lines and wrinkles, pigmentation, hydration, trans-epidermal water loss, and sebum excretion rate.
The natural cosmetic market is a multi-billion dollar industry. Nutraceuticals and food-based cosmetics are a growing trend within dermatology. Almonds are a rich dietary source of a range of fatty acids, phytochemical polyphenols, and antioxidants. Our previous study was a double blinded study that compared almond consumption interventions to a calorie matched intervention over 16 weeks. The study determined that that there was a statistically significant 8.41% improvement in wrinkle severity in the women that received almond supplementation. This proposal aims to now understand how the topical application of almond oil may influence the appearance of wrinkles and facial tone in post-menopausal women. Almond oil is rich in fatty acids and alpha-tocopherol. Tocopherol inhibits melanogenesis in melanocytes and topical alpha tocopherol has been shown to improve skin antioxidants and hyperpigmentation. A challenge of almond oil is that it is prone to oxidation due to its high unsaturated fatty acid concentrations. However, tocopherol has also been shown to improve almond oil stability.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Almond Oil | Experimental | Almond Oil. 1-2 Drops of randomized topical product will be applied on entire face nightly. Duration: 16 weeks |
|
| Almond oil augmented with 0.5% Vitamin E | Experimental | Almond oil augmented with 0.5% Vitamin E. 1-2 Drops of randomized topical product will be applied on entire face nightly. Duration: 16 weeks |
|
| 0.025% Tretinoin oil augmented with castor oil | Experimental | 0.025% Tretinoin oil augmented with castor oil. 1-2 Drops of randomized topical product will be applied on entire face nightly. Duration: 16 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topical Product: Almond Oil | Other | 1-2 Drops of randomized topical product will be applied on entire face nightly. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Facial wrinkles | Change in severity of wrinkles measured by photographic analysis (BTBP 3D Camera System) | 16 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Pigment intensity through the use of high resolution photography (BTBP Clarity Pro) | Change in the appearance of facial pigmentation by high resolution photography (BTBP Clarity Pro) and measures intensity of facial pigmentation. Higher scores indicate darker pigmentation. | 16 Weeks |
| Pigment intensity measured through SkinColorCatch. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nasima Afzal | Contact | 915-750-2463 | nasima@integrativeskinresearch.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Integrative Research Institute | Recruiting | Sacramento | California | 95819 | United States |
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| Topical Product: Almond oil augmented with 0.5% Vitamin E | Other | 1-2 Drops of randomized topical product will be applied on entire face nightly. |
|
| Topical Product: 0.025% Tretinoin oil augmented with castor oil | Other | 1-2 Drops of randomized topical product will be applied on entire face nightly. |
|
Change in the appearance of facial pigmentation will be measured on both cheeks through the use of a handheld device known as the SkinColorCatch with quantitative output for pigment intensity. |
| 16 Weeks |
| Changes in skin hydration | Change in skin hydration will be measured on both cheeks through the use of a non-invasive device known as the Moisturemeter. | 16 Weeks |
| Sebum excretion rate | Measure of skin sebum via sebumeter | 16 Weeks |
| Tolerability Assessment Questionnaire | A 6 question survey based on the self-assessment about the tolerability of the topical skin product. The scale ranges from 0-3 with 0 being the best outcome possible and with 3 being the worst. "0" as none, "1" as mild, "2" as moderate, or "3" as severe. | 16 Weeks |
| Transepidermal water loss | Change in transepidermal water loss (TEWL) using the Vapometer | 16 Weeks |
| ID | Term |
|---|---|
| D004535 | Ehlers-Danlos Syndrome |
| ID | Term |
|---|---|
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006474 | Hemorrhagic Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D012868 | Skin Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D003095 | Collagen Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D014810 | Vitamin E |
| D004364 | Pharmaceutical Preparations |
| D002368 | Castor Oil |
| ID | Term |
|---|---|
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D005224 | Fats, Unsaturated |
| D005223 | Fats |
| D008055 | Lipids |
| D010938 | Plant Oils |
| D009821 | Oils |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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