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NCT Number: NCT06571721

The Effects of Topical Almond Oil and Tretinoin on Facial Wrinkles

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Integrative Research Institute

Sacramento, California, 95819, United States

Location status: Recruiting

Location contact

Nasima Afzal

CONTACT

[email protected]

915-750-2463

Raja Sivamani, MD

PRINCIPAL_INVESTIGATOR

Rubaina Dang, ND

SUB_INVESTIGATOR

Sarah Adnan

CONTACT

[email protected]

9157502463

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Topical Product: Almond Oil

Other

1-2 Drops of randomized topical product will be applied on entire face nightly.

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.

Primary outcomes

  1. Facial wrinkles

    Time frame: 16 Weeks

    Change in severity of wrinkles measured by photographic analysis (BTBP 3D Camera System)

Secondary outcomes

  1. Changes in Pigment intensity through the use of high resolution photography (BTBP Clarity Pro)

    Time frame: 16 Weeks

    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.

  2. Pigment intensity measured through SkinColorCatch.

    Time frame: 16 Weeks

    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.

  3. Changes in skin hydration

    Time frame: 16 Weeks

    Change in skin hydration will be measured on both cheeks through the use of a non-invasive device known as the Moisturemeter.

  4. Sebum excretion rate

    Time frame: 16 Weeks

    Measure of skin sebum via sebumeter

  5. Tolerability Assessment Questionnaire

    Time frame: 16 Weeks

    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.

  6. Transepidermal water loss

    Time frame: 16 Weeks

    Change in transepidermal water loss (TEWL) using the Vapometer

Study contacts

Contact information is provided by the study sponsor or research team.

Nasima Afzal

CONTACT

[email protected]

915-750-2463

Sponsors and collaborators

Lead sponsor

Integrative Skin Science and Research

Industry

Registry information

Official study title

Prospective, Double-Blinded, Randomized Study of Topical Almond Oil and Tretinoin on Facial Wrinkles

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 26, 2024
Registry last updated
Aug 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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