Actively Recruiting
Prospective, Double-Blinded, Randomized Study of Topical Almond Oil and Tretinoin on Facial Wrinkles
Led by Integrative Skin Science and Research · Updated on 2024-08-28
90
Participants Needed
1
Research Sites
25 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of topical almond oil, almond oil with 0.5% vitamin E, and 0.025% tretinoin oil with castor oil on facial fine lines, wrinkles, pigmentation, hydration, water loss through the skin, and sebum production. This study focuses on post-menopausal women with Fitzpatrick skin types 1, 2, and 3, aiming to understand how these products influence skin appearance and tone. The study builds on prior research showing almond supplementation improved wrinkle severity. Participants will be randomly assigned to one of three groups applying 1-2 drops of either almond oil, almond oil with vitamin E, or tretinoin oil with castor oil to their entire face every night for 16 weeks. The study is single-blinded and includes a washout period where participants must stop using other topical cosmetic products that affect collagen and pigment. The interventions are compared to assess their impact on skin condition. During the study, participants will undergo assessments including high-resolution photography to measure pigmentation, skin hydration tests, sebum excretion rate measurements, transepidermal water loss evaluation, and a tolerability questionnaire. The primary outcome is the change in facial wrinkles over 16 weeks. The trial includes monitoring for safety and adherence, with the total participation lasting 16 weeks.
CONDITIONS
Brief Title
The Effects of Topical Almond Oil and Tretinoin on Facial Wrinkles
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Post-menopausal women of Fitzpatrick skin types 1, 2, and 3
- Individuals with facial fine lines and wrinkles
You will not qualify if you...
- 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 collagen production deficiency such as Ehlers-Danlos syndromes
- Individuals who have had cosmetic facial procedures within 3 months or deeper chemical peels within 1 year prior to enrollment
- Individuals unwilling to discontinue vitamin E supplements and foods such as nuts, sunflower seeds, or sunflower oil during the study
- Individuals unwilling to stop topical cosmetic products that affect collagen and pigment during the study or undergo a 2-week washout of such products including retinoids, antioxidants like vitamins C and E, pigment reducing agents, or nut oil-containing topicals during the study period or washout phase before starting the study treatment
- Individuals unwilling to comply with study product application and restrictions during the study period or washout phase before starting the study treatment or washout phase before starting the study treatment
- Individuals unwilling to comply with study product application and restrictions during the study period or washout phase before starting the study treatment or washout phase before starting the study treatment
- Individuals unwilling to comply with study product application and restrictions during the study period or washout phase before starting the study treatment or washout phase before starting the study treatment
- Individuals unwilling to comply with study product application and restrictions during the study period or washout phase before starting the study treatment or washout phase before starting the study treatment
- Individuals unwilling to comply with study product application and restrictions during the study period or washout phase before starting the study treatment or washout phase before starting the study treatment
- Individuals unwilling to comply with study product application and restrictions during the study period or washout phase before starting the study treatment or washout phase before starting the study treatment
- Individuals unwilling to comply with study product application and restrictions during the study period or washout phase before starting the study treatment or washout phase before starting the study treatment
- Individuals unwilling to comply with study product application and restrictions during the study period or washout phase before starting the study treatment or washout phase before starting the study treatment
- Individuals unwilling to comply with study product application and restrictions during the study period or washout phase before starting the study treatment or washout phase before starting the study treatment
- Individuals unwilling to comply with study product application and restrictions during the study period or washout phase before starting the study treatment or washout phase before starting the study treatment
- Individuals unwilling to comply with study product application and restrictions during the study period or washout phase before starting the study treatment or washout phase before starting the study treatment
- Individuals unwilling to comply with study product application and restrictions during the study period or washout phase before starting the study treatment or washout phase before starting the study treatment
- 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.
- 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.
- 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.
- 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.
- Individuals unwilling to comply with study product application and restrictions during the study period or washout phase before starting the study treatment
- Individuals unwilling to comply with study product application and restrictions during the study period or washout phase before starting the study treatment
- Individuals unwilling to comply with study product application and restrictions during the study period or washout phase before starting the study treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 16 weeks
Participants apply 1-2 drops of a randomized topical product (Almond Oil, Almond Oil with Vitamin E, or 0.025% Tretinoin oil with castor oil) on their entire face nightly.
Weekly visits for up to 16 weeks
Trial Site Locations
Total: 1 location
1
Integrative Research Institute
Sacramento, California, United States, 95819
Actively Recruiting
Research Team
N
Nasima Afzal
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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