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.
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 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).
Parallel
Standardized Saffron Extract (Crocus Sativus L) 10 mg Capsule
Dietary supplementMode of Usage: Administer one capsule once daily after meal, ideally at the same time each day to maintain consistency in absorption. Swallow the capsule whole with a full glass of water; do not crush, break, or chew the capsule. Frequency: Once a day, after lunch Route of administration: Oral Storage Condition: Store in cool and dry place, away from sunlight, heat and moisture.
Placebo (capsules containing Maltodextrin, Calcium carbonate, Sunset yellow, Maize starch, Mg Stearate, Talc)
Other interventionMode of Usage: Administer one capsule once daily after meal, ideally at the same time each day to maintain consistency in absorption. Swallow the capsule whole with a full glass of water; do not crush, break, or chew the capsule. Frequency: Once a day, after lunch Route of administration: Oral Storage Condition: Store in cool and dry place, away from sunlight, heat and moisture.
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
By using Visioscan® VC 20 Plus
To evaluate the effectiveness of test products by assessing change in skin tone - L*, a*, b*, and ITA within and between product groups
By using Skin Colorimeter CL 400
To evaluate the effectiveness of test products by assessing change in skin elasticity and firmness within and between product groups
By using Cutometer Dual MPA 580 (R0 and R2)
To evaluate the effectiveness of test products by assessing change in skin texture such as skin dryness, redness, fine lines, coarse wrinkles, laxity, roughness and sallowness within and between product groups
By Physician Global Assessment (PGA) using Griffith's scale by Dermatologist or dermatologist trained evaluator
To evaluate the effectiveness of test products by assessing change in wrinkles within and between product groups
Evaluated through Dermatological Evaluation using Glogau Scoring Scale
4. To evaluate the effectiveness of test products by assessing change in skin pigmentation evaluated through Dermatological Evaluation using Skin Pigmentation Scoring within and between product groups.
By using Melasma Area and Severity Index Scale
To evaluate the safety of the test product by clinical laboratory parameters
complete blood count (CBC), Biochemistry, Urinalysis
To evaluate the safety of the test product
By the monitoring of product emergent systematic evaluation of adverse events
To evaluate the safety of the test treatment by checking compliance towards the test treatments and daily diary entries
For compliance-capsule counts
Click on the lead sponsor to view all of their trials.
NovoBliss Research Pvt Ltd
Lead sponsor
Pharmanza Herbal Private Ltd
Collaborator
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