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 range30 Years – 55 Years
SexALL
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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.
✓. 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.
✕
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 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.