Study to Evaluate the Efficacy of Blue Fenugreek Kale Extract (BFKE) on Skin

Study Overview
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Brief Summary
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Participants will be supplemented BFKE for a period of 8-weeks to improve skin health. The objective of the study is to evaluate the 'Transepidermal Water Loss (TEWL)' that characterizes the skin barrier function of stratum corneum. Additional parameters include, evaluation of skin moisture content, wrinkling, elasticity, sagging, radiance and also on inflammatory biomarkers.

Official Title
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A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy of Blue Fenugreek Kale Extract (BFKE) on Skin.

Conditions
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Skin Health

Intervention / Treatment
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* Other: Blue fenugreek kale extract
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy, adult female participants aged ≥ 30 and ≤ 55 years. Participants with signs of poor skin barrier as determined by Trans-epidermal water loss ≥ 15 g/m2/h on forehead. Participants with skin type II to IV as per Fitzpatrick skin type calculator. Participants with skin type II and III as per Glogau's classification of photoageing skin. Participants must have Body Mass Index (BMI) ≥ 18.5 ≤ 29.9 kg/m2. Participants with moderate signs of Melasma as assessed by the investigators. Participants ready to abstain from any cosmetic or drug-based cream, ointment, lotion and other products apart from the ones allowed during study period. Participants ready to rinse their face only with water and to refrain from using soap, facewash, make-up etc. or any other cosmetic care related products 12 hrs. prior to any assessment visit. Exclusion Criteria: Unwilling to forgo any aesthetic or dermatological treatments or procedures during the study period. Participants with visible scarring on face. Participants having any form of skin disorder on the Nasolabial fold. Water consumption history of ≤ 500 ml and ≥ 3000 ml per day. Smoking or using any tobacco products. Participants presently undergoing or had undergone treatment for softening or reducing wrinkles in the last 3 months. Having a history of chronic skin allergies. History of heavy caffeine usage ≥ 4 cups in a day. Binge drinkers as defined by consumption of 4 or more alcohol containing beverages within 2 hours. Presence of unstable, acutely symptomatic, or life-limiting illness. Participants taking any vitamins and other related supplements. Menopausal and peri-menopausal females. Females who are pregnant/planning to be pregnant/lactating or taking any oral contraceptives. Females who have had participated in a study of an investigational product 90 days prior to the screening.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Blue fenugreek kale extract<br>One capsule to be taken orally before breakfast and one capsule after lunch, with water. | Other: Blue fenugreek kale extract<br>* One capsule to be taken orally before breakfast and one capsule after lunch, with water.<br>|
| Placebo Comparator: Placebo<br>One capsule to be taken orally before breakfast and one capsule after lunch, with water. | Other: Placebo<br>* One capsule to be taken orally before breakfast and one capsule after lunch, with water.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trans Epidermal Water Loss (TEWL) using Tewameter®. | To evaluate the effect of 8-week consumption of BFKE on skin barrier function as evaluated by Trans Epidermal Water Loss (TEWL) using Tewameter®. | From Base line Day 0 to day 56 | 
| Skin moisture | skin hydration as measured by skin moisture (forehead & forearm) using skin moisture analyzer. | From Base line Day 0 to day 56 | 
| Modified Fitzpatrick Wrinkle Severity Scale | Changes in the wrinkle class from Class 3.0 indicated worst means Deep wrinkle. Deep and furrow wrinkle; more than 3-mm wrinkle depth to Class 0 indicates Good means No wrinkle. No visible wrinkle; continuous skin line. | From Base line Day 0 to day 56 | 
| Ezure Sagging scale | Cheek with Highest sagging score means Very severe sagging indicates worst and Lowest sagging score means No sagging indicates better | From Base line Day 0 to day 56 | 
| Pinch recoil test | A decrease in pinch recoil time is associated with improvement in skin elasticity/firmness. | From Base line Day 0 to day 56 | 
| Skin parameters using a participant based self-assessment questionnaire | Highest Score represents Better and lowest Score represents Worst | From Base line Day 0 to day 56 | 
| Investigator's global assessment using 5-point Likert scale | The Study Investigator will assess on a scale of 0 (Very poor) to 4 (Excellent) as to how beneficial or vice-versa was the treatment experience over the study period. | From Base line Day 0 to day 56 | 
| Participant's global assessment using 5-point Likert scale | The Participant will self-assess on a scale of 0 (Very poor) to 4 (Excellent) as to how beneficial or vice-versa was the treatment experience over the study period. | From Base line Day 0 to day 56 | 
| Inflammatory biomarkers | Change in the levels of Inflammatory biomarkers within specified range | From Base line Day 0 to day 56 | 
| Allergic skin inflammation as assessed by Eosinophil to basophil ratio and Neutrophil to lymphocyte ratio. | Change in the levels of Eosinophil to basophil ratio and Neutrophil to lymphocyte ratio within specified range | From Base line Day 0 to day 56 | 
| Oxidative Stress as assessed by Malondialdehyde concentration. | malondialdehyde concentration of the samples will be measured as an index of lipid peroxidation | From Base line Day 0 to day 56 |