None listed
Conditions
Interventions
Intervention1: Standardized Saffron Extract (Crocus Sativus L) 10 mg Capsule: Manufactured & Marketed By: Pharmanza Herbal Pvt. Ltd.
Mode of Usage: Administer one capsule once daily after meal, idea
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.
Dura
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.
Durat
Sponsors
Pharmanza Herbal Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1) Age: 30 to 55 years (both inclusive) at the time of consent. 2) 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. 3) Females of childbearing potential should have a self-reported negative urine pregnancy test at the time of screening visit. 4) Subjects should not have used any cosmetic, nutraceutical or therapeutic products for skin ageing in last 1 month. 5) Subjects must be willing to stop using any cosmetics or any medical products for skin ageing for the duration of the study. 6) Subjects are not allowed to participate in any other study until this study is complete. 7) Subjects must be willing and able to follow the study directions and to return for all specified visits with the product. 8) Subjects must agree to record each use of the test products in the subject s diary card on daily basis. 9) Subjects must agree to record medication use during the study.
Exclusion criteria
Exclusion criteria: 1) Subjects who are on steroids for last six months and using immunosuppressive, anti-inflammatory, or hormone-modulating medications that may interfere with study outcomes. 2) Subjects who have used any cosmetic, nutraceutical or therapeutic products for skin last one months. 3) 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. 4) Subjects with a known history of hypersensitivity, allergic reactions, or intolerance (such as drowsiness, stomach discomfort, nausea, or vomiting). 5) Subjects with other dermatologic diseases whose presence or products could interfere with the assessment of study. 6) Subjects that are pregnant and/or breastfeeding. 7) The subject has a known allergy or sensitivity to product ingredients. 8) Subjects if do not agree to limit sun exposure to affected areas such as face during prolonged sun exposure. 9) The subject has any other skin conditions i.e. cuts, scratches, ring worms, etc. which in the opinion of the Investigator, will interfere with the study results or will create undue risk for the subject. 10) The subject has any of the conditions or factors that the Investigator believes may affect the response of the skin or the interpretation of the test results. 11) The subject is currently taking or has taken any medication, which the Investigator believes may influence the interpretation of the data. 12) Any other condition which could warrant exclusion from the study, as per the dermatologist s/investigator s discretion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.To evaluate the effectiveness of test products by assessing change in facial wrinkles and finelines of Crow s feet area, skin texture dryness, roughness, smoothness, pores using Visioscan VC 20 Plus within and between product groups. 2. To evaluate the effectiveness of test products by assessing change in skin tone L, a, b, and ITA using Skin Colorimeter CL 400 within and between product groups.Timepoint: 1. Baseline on Day 01 and post usage of test products on Day 45 ( 2 Days), Day 90 ( 2 Days), Day 120 ( 2 Days) 2. Baseline on Day 01 and post usage of test products on Day 45 ( 2 Days), Day 90 ( 2 Days), Day 120 ( 2 Days) | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the effectiveness of test products by assessing change in skin elasticity and firmness using Cutometer Dual MPA 580 (R0 and R2) within and and between product groups.Timepoint: Baseline on Day 01 and post usage of test products on Day 45 ( 2 Days), Day 90 ( 2 Days), Day 120 ( 2 Days);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 evaluated through Physician Global Assessment (PGA) using Griffith s scale by Dermatologist or dermatologist trained evaluator within and between product groups.Timepoint: Baseline on Day 01 and post usage of test products on Day 45 ( 2 Days) and Day 90 ( 2 Days);To evaluate the effectiveness of test products by assessing change wrinkles evaluated through Dermatological Evaluation using Glogau Scoring Scale within and between product groups.Timepoint: Baseline on Day 01 and post usage of test products on Day 45 ( 2 Days) and Day 90 ( 2 Days);To evaluate the effectiveness of test products by assessing change in skin pigmentation evaluated through Dermatological Evaluation using Skin Pigmentation Scoring MASI Scale within and between product groups.Timepoint: Baseline on Day 01 and post usage of test products on Day 45 ( 2 Days) and Day 90 ( 2 Days);To evaluate the effectiveness of test products by assessing change in skin hydration using Corneometer CM 825 within and between product groups.Timepoint: Baseline on Day 01 and post usage of test products on Day 45 ( 2 Days), Day 90 ( 2 Days), Day 120 ( 2 Days);To evaluate the effectiveness of test products by assessing change in skin thickness and density (Skin Ultrasound) using Mindray DC 70 or similar within and between product groupsTimepoint: Baseline on Day 01 and post usage of test products on Day 90 ( 2 Days);To evaluate the effectiveness of test products by assessing change in change in visual appearance of facial skin using Visioface RD within | — |
Countries
India
Contacts
Public ContactMaheshwari Patel
NovoBliss Research Private Limited
Outcome results
None listed