Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:07 PM
Ignite Modification Date:
2025-12-24 @ 12:07 PM
NCT ID:
NCT05011461
Eligibility Criteria:
Inclusion Criteria:
* Post-menopausal women of Fitzpatrick skin types 1 and 2
Exclusion Criteria:
* 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.
* 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.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
40 Years
Study:
NCT05011461
Study Brief:
Protocol Section:
NCT05011461