Clinical trial NCT05011461: The Effect of Topical Almond Oil vs. Topical Retinol on The Appearance of Facial Wrinkles
Official title: The Effect of Topical Almond Oil vs. Topical Retinol on The Appearance of Facial Wrinkles
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wrinkles
Skin
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2021-08-18
Enrollment: 40
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this experiment is to analyze wrinkle severity, the skin barrier and facial pigmentation level after topical almond oil application, compared to the use of topical retinol. Both the almond oil and the 0.5% topical retinol studied is investigational.

Detailed description: The natural cosmetic market is a multi-billion-dollar industry. Nutraceuticals and foodbased cosmetics are a growing trend within dermatology. Almonds are a rich dietary source of a range of fatty acids, phytochemical polyphenols, and antioxidants \[1\]. The previous study done by Dr. Raja Sivamani was a double blinded study that compared oral almond intake to a calorie matched non-nut-based intake over 12 weeks.The study determined that that there was a statistically significant improvement in wrinkle severity and pigment intensity 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 \[2\]. Tocopherol inhibits melanogenesis in melanocytes \[3\] and topical alpha tocopherol has been shown to improve skin antioxidants and hyperpigmentation \[4, 5\].

Eligibility criteria: Inclusion Criteria:

* Post-menopausal women of Fitzpatrick skin types 1 and 2

Exclusion Criteria:

* Those with a nut allergy
* Smoking is an independent risk factor and serves as a confounder for the development of facial wrinkles and photoaging \[14\]. Therefore, current smokers, those that have smoked within the past year, and former smokers with greater than a 20-pack year history of smoking will be excluded.
* Those with an autoimmune photosensitive condition or a known genetic condition with a deficiency in collagen production (such as Ehlers-Danlos syndromes) will be excluded as this can be a confounder for facial wrinkles.
* Those who have undergone any cosmetic procedures to the face in the 4 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 will also not be eligible.
* Individuals who are unwilling to discontinue vitamin E food sources during the washout and intervention. This includes

  * Vitamin E containing supplements.
  * Sunflower seeds or sunflower oil.
  * All nuts.
* 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, a retinoid, azelaic acid, kojic acid, pomegranate seed oil, and other similar agents per the discretion of the investigator, 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: Appearance of wrinkle severity
timeFrame: 12-weeks
Secondary outcomes:
measure: Appearance of facial color tone and evenness
timeFrame: 12-weeks
measure: Appearance of facial redness
timeFrame: 12-weeks
measure: Subjective tolerability
timeFrame: 12-weeks
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis Department of Dermatology, Clinical Trials Unit
state: California
Study officials:
affiliation: UC Davis Dermatology
name: Raja Sivamani, M.D.
role: PRINCIPAL_INVESTIGATOR
References: