Clinical Study to Assess Safety, Effectiveness and In-Use Tolerability of Saffron Extract Capsule… (NCT07324759) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Clinical Study to Assess Safety, Effectiveness and In-Use Tolerability of Saffron Extract Capsules for Improving Skin Health and Reducing Signs of Aging on Healthy Adult Male and Female Subjects.
50 participantsStarted 2026-01-01
Plain-language summary
This is a randomized, double-blind, comparative, two-arm, prospective, interventional, multi-centre clinical study to evaluate the safety, efficacy, and in-use tolerability of test products, standardized saffron extract capsules, on skin rejuvenation and age-defying benefits in healthy adult male and female subjects.
Who can participate
Age range
30 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age: 30 to 55 years (both inclusive) at the time of consent.
. Sex: Adult male and female having wrinkles and fine lines at crow feet's area, facial hyperpigmentation and dark spots such as tan, pimple marks, sunspots, age spots, uneven skin tone on both side of face.
. Females of childbearing potential should have a self-reported negative urine pregnancy test at the time of screening visit.
. Subjects should not have used any cosmetic, nutraceutical or therapeutic products for skin ageing in last 1 month.
. Subjects must be willing to stop using any cosmetics or any medical products for skin ageing for the duration of the study.
. Subjects are not allowed to participate in any other study until this study is complete.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To evaluate the effectiveness of test products in terms of change in facial wrinkles and finelines of Crow's feet area, skin texture -dryness, roughness, smoothness, pores within and between product groups
Timeframe: Baseline on Day 01 and post usage of test products on Day 45 (±2 Days), Day 90 (±2 Days), Day 120 (±2 Days)
2
To evaluate the effectiveness of test products by assessing change in skin tone - L*, a*, b*, and ITA within and between product groups
Timeframe: Baseline on Day 01 and post usage of test products on Day 45 (±2 Days), Day 90 (±2 Days), Day 120 (±2 Days)
. Subjects must be willing and able to follow the study directions and to return for all specified visits with the product.
. Subjects must agree to record each use of the test products in the subject's diary card on daily basis.
Exclusion criteria
. Subjects who are on steroids for last six months and using immunosuppressive, anti-inflammatory, or hormone-modulating medications that may interfere with study outcomes.
. Subjects who have used any cosmetic, nutraceutical or therapeutic products for skin last one months.
. Subjects currently using any oral supplement and topical products containing kojic acid, glycolic acid, niacinamide, alpha arbutin, vitamin C, retinoids, peptides, exfoliating acids, or any other skin-lightening, anti-ageing, or depigmenting agents within the past 4 weeks.
. Subjects with a known history of hypersensitivity, allergic reactions, or intolerance (such as drowsiness, stomach discomfort, nausea, or vomiting).
. Subjects with other dermatologic diseases whose presence or products could interfere with the assessment of study.
. Subjects that are pregnant and/or breastfeeding.
. The subject has a known allergy or sensitivity to product ingredients.
. Subjects if do not agree to limit sun exposure to affected areas such as face during prolonged sun exposure.