Collagen DegenerationNCT06571721
The Effects of Topical Almond Oil and Tretinoin on Facial Wrinkles
A study testing Topical Product: Almond Oil, Topical Product: Almond oil augmented with 0.5% Vitamin E and Topical Product: 0.025% Tretinoin oil augmented with castor oil in people with Collagen Degeneration and Wrinkle, run by Integrative Skin Science and Research at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Collagen Degeneration, Wrinkle, Pigmentation
- What is being tested?
- Topical Product: Almond Oil, Topical Product: Almond oil augmented with 0.5% Vitamin E and Topical Product: 0.025% Tretinoin oil augmented with castor oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jul 2024to 22 Jul 2025
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Post-menopausal women of Fitzpatrick skin types 1, 2, and 3
- Individuals with facial fine lines and wrinkles
Who cannot join
- 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)
Show all 13Show fewer
- 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 locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Integrative Research Institute
Sacramento, California, 95819
Nasima Afzal, 915-750-2463, nasima@integrativeskinresearch.com
Sarah Adnan, 9157502463, sarah@integrativeskinresearch.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Collagen Degeneration, Wrinkle, Pigmentation, Elastic Skin, Sebum Deficiency
- Being tested
- Topical Product: Almond Oil, Topical Product: Almond oil augmented with 0.5% Vitamin E, Topical Product: 0.025% Tretinoin oil augmented with castor oil
- Keywords
- Facial Wrinkles, Skin biophysical properties, Photoaging, Pigmentation
- Medical subject headings
- Ehlers-Danlos Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical Product: Almond OilOther
1-2 Drops of randomized topical product will be applied on entire face nightly.
Topical Product: Almond oil augmented with 0.5% Vitamin EOther
1-2 Drops of randomized topical product will be applied on entire face nightly.
Topical Product: 0.025% Tretinoin oil augmented with castor oilOther
1-2 Drops of randomized topical product will be applied on entire face nightly.
| Study group | Role | What they receive |
|---|---|---|
| Almond Oil | Experimental | Almond Oil. 1-2 Drops of randomized topical product will be applied on entire face nightly. Duration: 16 weeks Receives: Other: Topical Product: Almond Oil |
| Almond oil augmented with 0.5% Vitamin E | Experimental | 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 Receives: Other: Topical Product: Almond oil augmented with 0.5% Vitamin E |
| 0.025% Tretinoin oil augmented with castor oil | Experimental | 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 Receives: Other: Topical Product: 0.025% Tretinoin oil augmented with castor oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Facial wrinkles
Change in severity of wrinkles measured by photographic analysis (BTBP 3D Camera System)
Measured: 16 Weeks
Secondary outcomes (6)
Changes in Pigment intensity through the use of high resolution photography (BTBP Clarity Pro)
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.
Measured: 16 Weeks
Pigment intensity measured through SkinColorCatch.
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.
Measured: 16 Weeks
Changes in skin hydration
Change in skin hydration will be measured on both cheeks through the use of a non-invasive device known as the Moisturemeter.
Measured: 16 Weeks
Sebum excretion rate
Measure of skin sebum via sebumeter
Measured: 16 Weeks
Tolerability Assessment Questionnaire
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.
Measured: 16 Weeks
Transepidermal water loss
Change in transepidermal water loss (TEWL) using the Vapometer
Measured: 16 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study start22 Jul 2024
- Primary completion22 Jan 2025 (estimated)
- Study completion22 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Collagen DegenerationStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Integrative Skin Science and Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06571721
- Sponsor's protocol ID
- IRI24_01_AlmondOil
- Status last verified
- Aug 2024
- First submitted
- 23 Aug 2024
- Last updated
- 28 Aug 2024
- 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 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Double-Blinded, Randomized Study of Topical Almond Oil and Tretinoin on Facial Wrinkles
- ClinicalTrials.gov ID
- NCT06571721
- Acronym / sponsor ID
- IRI24_01_AlmondOil
- Conditions
- Collagen Degeneration, Wrinkle, Pigmentation, Elastic Skin, Sebum Deficiency
- Keywords
- Facial Wrinkles, Skin biophysical properties, Photoaging, Pigmentation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Integrative Skin Science and ResearchIndustry (pharma, biotech, devices)
- Study start
- 22 Jul 2024 (actual)
- Primary completion
- 22 Jan 2025 (estimated)
- Study completion
- 22 Jul 2025 (estimated)
- First posted
- 26 Aug 2024 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Almond Oil | Experimental | Other: Topical Product: Almond OilAlmond Oil. 1-2 Drops of randomized topical product will be applied on entire face nightly. Duration: 16 weeks |
| Almond oil augmented with 0.5% Vitamin E | Experimental | Other: Topical Product: Almond oil augmented with 0.5% Vitamin EAlmond oil augmented with 0.5% Vitamin E. 1-2 Drops of randomized topical product will be applied on entire face nightly. Duration: 16 weeks |
| 0.025% Tretinoin oil augmented with castor oil | Experimental | Other: Topical Product: 0.025% Tretinoin oil augmented with castor oil0.025% Tretinoin oil augmented with castor oil. 1-2 Drops of randomized topical product will be applied on entire face nightly. Duration: 16 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Post-menopausal women of Fitzpatrick skin types 1, 2, and 3
- Individuals with facial fine lines and wrinkles
Key exclusion criteria (13 listed)
- 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
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 |
|---|---|---|
| Topical Product: Almond Oil1-2 Drops of randomized topical product will be applied on entire face nightly. | Other | Almond Oil |
| Topical Product: Almond oil augmented with 0.5% Vitamin E1-2 Drops of randomized topical product will be applied on entire face nightly. | Other | Almond oil augmented with 0.5% Vitamin E |
| Topical Product: 0.025% Tretinoin oil augmented with castor oil1-2 Drops of randomized topical product will be applied on entire face nightly. | Other | 0.025% Tretinoin oil augmented with castor oil |
Primary outcome
Facial wrinkles
Time frame: 16 Weeks
Change in severity of wrinkles measured by photographic analysis (BTBP 3D Camera System)
6 secondary outcomes
Changes in Pigment intensity through the use of high resolution photography (BTBP Clarity Pro)
Time frame: 16 Weeks
Pigment intensity measured through SkinColorCatch.
Time frame: 16 Weeks
Changes in skin hydration
Time frame: 16 Weeks
Sebum excretion rate
Time frame: 16 Weeks
Tolerability Assessment Questionnaire
Time frame: 16 Weeks
Transepidermal water loss
Time frame: 16 Weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2024.
- Individual participant dataSharing planned: No
Related trials for Collagen Degeneration
Active, not recruitingObservational study
Early Check: Expanded Screening in Newborns
Spinal Muscular Atrophy, Fragile X Syndrome
Recruiting
Hydrolyzed Collagen Formulation vs Placebo in Knee Osteoarthritis
Knee Osteoarthritis
RecruitingPhase 3
Comparison of Epi-ON Corneal Collagen Crosslinking Performed Using an 18-Minute UVA Exposure vs. a 24-Minute UVA Exposure on Eyes With Ectatic Corneal Diseases
Keratoconus, Ectasia of Cornea
RecruitingPhase 3
Compassionate Use Study of Epi-ON Corneal Collagen Crosslinking Performed Using UVA Exposure on Eyes With Ectatic Corneal Diseases for Subjects With Down Syndrome
Down Syndrome (DS), Keratoconus
RecruitingObservational study
Magic Angle Direction Imaging (MADI) ACL Study
Anterior Cruciate Ligament Injuries, Meniscus Tear
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Topical Product: Almond Oil, Topical Product: Almond oil augmented with 0.5% Vitamin E and Topical Product: 0.025% Tretinoin oil augmented with castor oil in people with Collagen Degeneration and Wrinkle, run by Integrative Skin Science and Research 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 2 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: status not confirmed, as of the sponsor's last update on 28 Aug 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nasima Afzal (915-750-2463, nasima@integrativeskinresearch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Facial wrinkles (time frame: 16 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 28 Aug 2024.