WrinklesNCT05011461
The Effect of Topical Almond Oil vs. Topical Retinol on The Appearance of Facial Wrinkles
A study testing Almond Oil in people with Wrinkles and Skin, run by University of California, Davis at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older, women only
- What is being tested?
- Almond Oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 17 May 2021to 5 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Post-menopausal women of Fitzpatrick skin types 1 and 2
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
UC Davis Department of Dermatology, Clinical Trials Unit
Sacramento, California, 95816
About this study
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.
Read the 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].
- Being tested
- Almond Oil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Almond OilOther
Almond Oil Pressed Cold
| Study group | Role | What they receive |
|---|---|---|
| Almond Oil | Experimental | Almond Oil Pressed Cold Receives: Other: Almond Oil |
| Topical Retinol | Active comparator | Retinol Lotion 0.5% Receives: Other: Almond Oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Appearance of wrinkle severity
Facial wrinkles will be assessed with the use of a validated high resolution facial modeling system. The high-resolution facial modeling system will be performed with the 3D Clarity Pro® Facial Modeling and Analysis System (Brigh-Tex BioPhotonics, San Jose, CA) and will specifically assess for wrinkle severity and wrinkle length as was performed in the previous pilot study.
Measured: 12-weeks
Secondary outcomes (3)
Appearance of facial color tone and evenness
The facial color tone and evenness will be measured with a SkinColor Catch from Delfin Technologies. This device shows the RGB Colors, CIE L*a*b* and L*c*h* color space coordinates when the devivce is applied to the skin. Included is the link to the device (http://www.truesystem.co.kr/product/pdf/SkinColorCatch%20Brochure%202016.pdf).
Measured: 12-weeks
Appearance of facial redness
We will quantify the presence of facial redness with a SkinColor Catch from Delfin Technologies. We will measure the RGB colors and average them from each participant for each of the visits. Skin pigment, including the presence of redness, will be measured using a SkinColorCatch from Delfin Technologies . This device shows the RGB Colors, CIE L*a*b* and L*c*h* color space coordinates when the devivce is applied to the skin. Included is the link to the device (http://www.truesystem.co.kr/product/pdf/SkinColorCatch%20Brochure%202016.pdf).
Measured: 12-weeks
Subjective tolerability
To assess tolerability, we are going to use a Tolerability Assessment Questionnaire. The patient fills out the questionnaire on whether they currently have or had any itching, burning, stining, scaling, erythema, hypopigmentation or hyperpigmentation during application of the product. They measure any of the symptoms on a scale of 0-3, 0 being none, 3 being severe. They can also hand write any other effects that they noticed from the study.
Measured: 12-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2021
- Study start17 May 2021
- Primary completion5 Oct 2022
- Study completion5 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WrinklesStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raja Sivamani, MD, University of California, Davis
- Investigators
- Raja Sivamani, M.D., Principal investigator, UC Davis Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05011461
- Sponsor's protocol ID
- 1666459
- Status last verified
- Feb 2023
- First submitted
- 16 Aug 2021
- Last updated
- 14 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Topical Almond Oil vs. Topical Retinol on The Appearance of Facial Wrinkles
- ClinicalTrials.gov ID
- NCT05011461
- Acronym / sponsor ID
- 1666459
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- 17 May 2021 (actual)
- Primary completion
- 5 Oct 2022 (actual)
- Study completion
- 5 Oct 2022 (actual)
- First posted
- 18 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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].
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Almond Oil | Experimental | Other: Almond OilAlmond Oil Pressed Cold |
| Topical Retinol | Active comparator | Other: Almond OilRetinol Lotion 0.5% |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Post-menopausal women of Fitzpatrick skin types 1 and 2
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Almond OilAlmond Oil Pressed Cold | Other | Almond Oil, Topical Retinol |
Primary outcome
Appearance of wrinkle severity
Time frame: 12-weeks
Facial wrinkles will be assessed with the use of a validated high resolution facial modeling system. The high-resolution facial modeling system will be performed with the 3D Clarity Pro® Facial Modeling and Analysis System (Brigh-Tex BioPhotonics, San Jose, CA) and will specifically assess for wrinkle severity and wrinkle length as was performed in the previous pilot study.
3 secondary outcomes
Appearance of facial color tone and evenness
Time frame: 12-weeks
Appearance of facial redness
Time frame: 12-weeks
Subjective tolerability
Time frame: 12-weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raja Sivamani, M.D. principal investigator
UC Davis Dermatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Almond Oil in people with Wrinkles and Skin, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Appearance of wrinkle severity (time frame: 12-weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2023.