The Effects of Topical Almond Oil and Tretinoin on Facial Wrinkles
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Topical Product: Almond Oil, Topical Product: Almond oil augmented with 0.5% Vitamin E, Topical Product: 0.025% Tretinoin oil augmented with castor oil.
- Who it may be relevant to
- Registry conditions: Collagen Degeneration, Wrinkle, Pigmentation, Elastic Skin. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prospective, Double-Blinded, Randomized Study of Topical Almond Oil and Tretinoin on Facial Wrinkles
Overview
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.
Detailed description
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.
Interventions
- Other Topical Product: Almond Oil
1-2 Drops of randomized topical product will be applied on entire face nightly. - Other Topical Product: Almond oil augmented with 0.5% Vitamin E
1-2 Drops of randomized topical product will be applied on entire face nightly. - Other Topical Product: 0.025% Tretinoin oil augmented with castor oil
1-2 Drops of randomized topical product will be applied on entire face nightly.
Primary outcome measures
- Facial wrinkles [Time frame: 16 Weeks]
Secondary outcome measures (6)
- Changes in Pigment intensity through the use of high resolution photography (BTBP Clarity Pro) [Time frame: 16 Weeks]
- Pigment intensity measured through SkinColorCatch. [Time frame: 16 Weeks]
- Changes in skin hydration [Time frame: 16 Weeks]
- Sebum excretion rate [Time frame: 16 Weeks]
- Tolerability Assessment Questionnaire [Time frame: 16 Weeks]
- Transepidermal water loss [Time frame: 16 Weeks]
Eligibility criteria
Inclusion criteria
- Post-menopausal women of Fitzpatrick skin types 1, 2, and 3
- Individuals with facial fine lines and wrinkles
Exclusion criteria
- Individuals who are pregnant or breastfeeding
- Prisoners
- Adults unable to consent
- Those with a nut allergy or tocopherol allergy
- Current smokers, those that have smoked within the past year, and former smokers with greater than a 10-pack- year history of smoking
- Those with an autoimmune photosensitive condition or a known genetic condition with a deficiency in collagen production (such as Ehlers-Danlos syndromes)
- Those who have undergone any cosmetic procedures to the face in the 3 months prior to enrollment in the opinion of the investigator. People that have undergone deeper chemical peels (TCA based peels) within 1 year prior to enrollment
- Individuals who are unwilling to discontinue vitamin E containing supplements and food sources such as all nuts, sunflower seeds or sunflower oil during the washout and intervention
- Individual who are unwilling to discontinue topical cosmetic products during the duration of the study or unwilling to undergo a 2-week washout of topicals that are known to modulate collagen and pigment:
- Retinoids such as tretinoin, adapalene, retinol, except as provided by the study.
- Antioxidant ingredients such as vitamin C or vitamin E.
- Pigment reducing agents such as hydroquinone, azelaic acid, kojic acid, or a retinoid except for the retinol that is provided in this study.
- Topicals that contain a nut oil or nut extract as part of their ingredient list.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Integrative Research Institute — Sacramento
Identifiers
NCT: NCT06571721 · IRI24_01_AlmondOil