Clinical trial NCT06571721: The Effects of Topical Almond Oil and Tretinoin on Facial Wrinkles
Official title: Prospective, Double-Blinded, Randomized Study of Topical Almond Oil and Tretinoin on Facial Wrinkles
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Collagen Degeneration
Wrinkle
Pigmentation
Elastic Skin
Sebum Deficiency
Keywords: Facial Wrinkles
Skin biophysical properties
Photoaging
Pigmentation
Lead sponsor: Integrative Skin Science and Research
Sponsor class: INDUSTRY
First posted: 2024-08-26
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Primary outcomes:
measure: Facial wrinkles
timeFrame: 16 Weeks
Secondary outcomes:
measure: Changes in Pigment intensity through the use of high resolution photography (BTBP Clarity Pro)
timeFrame: 16 Weeks
measure: Pigment intensity measured through SkinColorCatch.
timeFrame: 16 Weeks
measure: Changes in skin hydration
timeFrame: 16 Weeks
measure: Sebum excretion rate
timeFrame: 16 Weeks
measure: Tolerability Assessment Questionnaire
timeFrame: 16 Weeks
measure: Transepidermal water loss
timeFrame: 16 Weeks
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Integrative Research Institute
state: California
Study officials:
References: