The Effects of Topical Almond Oil and Tretinoin on Facial Wrinkles

August 26, 2024 updated by: Integrative Skin Science and Research

Prospective, Double-Blinded, Randomized Study 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Almond Oil
Almond Oil. 1-2 Drops of randomized topical product will be applied on entire face nightly. Duration: 16 weeks
Other: Topical Product: Almond Oil
1-2 Drops of randomized topical product will be applied on entire face nightly.
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
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.
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Facial wrinkles
Time Frame: 16 Weeks
Change in severity of wrinkles measured by photographic analysis (BTBP 3D Camera System)
16 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
16 Weeks
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.
16 Weeks
Sebum excretion rate
Time Frame: 16 Weeks
Measure of skin sebum via sebumeter
16 Weeks
Transepidermal water loss
Time Frame: 16 Weeks
Change in transepidermal water loss (TEWL) using the Vapometer
16 Weeks
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.
16 Weeks
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.
16 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Integrative Skin Science and Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 22, 2024

Primary Completion (Estimated)

January 22, 2025

Study Completion (Estimated)

July 22, 2025

Study Registration Dates

First Submitted

August 23, 2024

First Submitted That Met QC Criteria

August 23, 2024

First Posted (Actual)

August 26, 2024

Study Record Updates

Last Update Posted (Actual)

August 28, 2024

Last Update Submitted That Met QC Criteria

August 26, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRI24_01_AlmondOil

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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