The Effect of Topical Almond Oil vs. Topical Retinol on The Appearance of Facial Wrinkles

NCT ID: NCT05011461

Last Updated: 2023-02-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-17
• Study Completion Date: 2022-10-05

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].

Conditions

Wrinkles; Skin

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Almond Oil

Almond Oil Pressed Cold

Group Type: EXPERIMENTAL

Almond Oil

Intervention Type: OTHER

Almond Oil Pressed Cold

Topical Retinol

Retinol Lotion 0.5%

Group Type: ACTIVE_COMPARATOR

Almond Oil

Intervention Type: OTHER

Almond Oil Pressed Cold

Interventions

Almond Oil

Almond Oil Pressed Cold

Intervention Type: OTHER

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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of California, Davis

OTHER

Sponsor Role: lead

Responsible Party

Raja Sivamani, MD

Associate Professor of Clinical Dermatology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Raja Sivamani, M.D.

Role: PRINCIPAL_INVESTIGATOR

UC Davis Dermatology

Locations

UC Davis Department of Dermatology, Clinical Trials Unit

Sacramento, California, United States

Countries

United States

Other Identifiers

1666459

Identifier Type: -

Identifier Source: org_study_id