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The Effects of Topical Almond Oil and Tretinoin on Facial Wrinkles

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender Female
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT06571721
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Integrative Skin Science and Research
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Collagen Degeneration, Wrinkle, Pigmentation, Elastic Skin, Sebum Deficiency
Additional Details

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.

Arms & Interventions

Arms

Experimental: Almond Oil

Almond Oil. 1-2 Drops of randomized topical product will be applied on entire face nightly. Duration: 16 weeks

Experimental: Almond oil augmented with 0.5% Vitamin E

Almond oil augmented with 0.5% Vitamin E. 1-2 Drops of randomized topical product will be applied on entire face nightly. Duration: 16 weeks

Experimental: 0.025% Tretinoin oil augmented with castor oil

0.025% Tretinoin oil augmented with castor oil. 1-2 Drops of randomized topical product will be applied on entire face nightly. Duration: 16 weeks

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Integrative Research Institute, Sacramento, California

Status

Recruiting

Address

Integrative Research Institute

Sacramento, California, 95819

Site Contact

Nasima Afzal

[email protected]

915-750-2463

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