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:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-26 @ 3:15 PM
NCT ID:
NCT07493850
Eligibility Criteria:
Inclusion Criteria:
1. Individuals who are willing to understand and sign a written informed consent form prior to the study.
2. Healthy male and female individuals aged between 30 to 55 years (both values included).
3. Individuals showing symptoms of aging, with mild to moderate wrinkles in crow's feet area based on PI discretion.
4. Individuals with any one of the following skin conditions along with mild to moderate wrinkles:
1. Under-eye dark circles
2. Hyperpigmentation spots (blemish) (post-inflammatory hyperpigmentation, acne marks, age spots, sunspots)
3. Dry dull skin
5. Individuals willing to maintain stable dietary patterns and maintain adequate hydration every day throughout the study
6. Individuals who are willing to attend all scheduled study visits at the test center and agree to refrain from applying any topical products (e.g.,moisturizers, creams, or similar treatments) 24 hours prior to each visit.
7. Willingness to participate in the study and comply with the study procedures and required visits.
Exclusion Criteria:
1. Individuals having an allergy to any of the components of the IP.
2. Use of another investigational product within 90 days prior to the screening visit.
3. Individuals with any dermatologic disorders or skin conditions that could interfere with the evaluation of proprietary supplement's effects.
4. Individuals having an underlying disease or surgical or medical condition that could put them at risk in the opinion of Principal Investigator, including anyuncontrolled chronic or serious disease that would prevent participation in the study, such as cancer, AIDS, diabetes, obesity, renal impairment, psychiatricdisorder, compromised immunity, etc.
5. Individuals having a history of self-reported allergies to cosmetic and/or sunscreen products.
6. Individuals who have used or are unwilling to abstain from using any topical or systemic skin-treatment products or dietary supplements with claims toimprove skin hydration, firmness, anti-aging, anti-wrinkle, skin lightening, or dyschromia correction - including those containing alpha/beta/poly-hydroxyacids, salicylic acid, vitamin C, collagen, hyaluronic acid, soy, CoQ-10, chondroitin sulfate, hydroquinone, corticosteroids, tretinoin, retinoids, or anycombination thereof - within 1 month prior to screening or during the study period.
7. Individuals currently using oral or topical health foods, supplements, pharmaceuticals, or cosmetics that claim whitening or skin-texture improvementeffects such as but not limited to glutathione, cysteine, placenta-based extracts, Vitamins C/E/A (retinol), astaxanthin, lycopene, etc., and who cannotrefrain from using them during the study period.
8. Individuals who have undergone any facial cosmetic or aesthetic procedures, including beauty injections, deep or superficial-to-mid chemical peels,dermabrasion, laser resurfacing, Thermage, tanning, cosmetic surgery, or any equivalent high-energy or anti-aging facial treatments, within 3 months priorto the screening visit.
9. Individuals who had hormone replacement therapy within 3 months preceding the screening visit.
10. Individuals who have used oral contraceptives or had changed contraceptive method within 3 months prior to the screening visit, or plan to modifycontraception treatment within the duration of study.
11. Employees of the clinical labs or other testing firms or laboratories, as well as those of cosmetic or raw-material manufacturers of topical products ortheir suppliers.
12. Individuals who are undergoing medical treatment or have a medical history of lupus, scleroderma, atopic dermatitis, acne, facial scarring, psoriasis,eczema, and other autoimmune/inflammatory scaly skin disorders.
13. History of uncontrolled hypertension with systolic blood pressure more than or equal to 140 mmHg and/or diastolic blood pressure more than or equalto 90 mmHg.
14. Females who are pregnant/planning to be pregnant/lactating or taking any oral contraceptives.
15. History of smoking or currently smoking and also using any form of smokeless tobacco.
16. Individuals having a history of or ongoing drug or alcohol abuse.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
55 Years
Study:
NCT07493850
Study Brief:
Protocol Section:
NCT07493850