Study to Evaluate the Efficacy of Blue Fenugreek Kale Extract (BFKE) on Skin
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Blue fenugreek kale extract One capsule to be taken orally before breakfast and one capsule after lunch, with water. |
Other: Blue fenugreek kale extract
One capsule to be taken orally before breakfast and one capsule after lunch, with water.
|
| Placebo Comparator: Placebo One capsule to be taken orally before breakfast and one capsule after lunch, with water. |
Other: Placebo
One capsule to be taken orally before breakfast and one capsule after lunch, with water.
|
Outcome Measures
Primary Outcome Measures
- Trans Epidermal Water Loss (TEWL) using Tewameter®. [From Base line Day 0 to day 56]
To evaluate the effect of 8-week consumption of BFKE on skin barrier function as evaluated by Trans Epidermal Water Loss (TEWL) using Tewameter®.
- Skin moisture [From Base line Day 0 to day 56]
skin hydration as measured by skin moisture (forehead & forearm) using skin moisture analyzer.
- Modified Fitzpatrick Wrinkle Severity Scale [From Base line Day 0 to day 56]
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.
- Ezure Sagging scale [From Base line Day 0 to day 56]
Cheek with Highest sagging score means Very severe sagging indicates worst and Lowest sagging score means No sagging indicates better
- Pinch recoil test [From Base line Day 0 to day 56]
A decrease in pinch recoil time is associated with improvement in skin elasticity/firmness.
- Skin parameters using a participant based self-assessment questionnaire [From Base line Day 0 to day 56]
Highest Score represents Better and lowest Score represents Worst
- Investigator's global assessment using 5-point Likert scale [From Base line Day 0 to day 56]
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.
- Participant's global assessment using 5-point Likert scale [From Base line Day 0 to day 56]
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.
- Inflammatory biomarkers [From Base line Day 0 to day 56]
Change in the levels of Inflammatory biomarkers within specified range
- Allergic skin inflammation as assessed by Eosinophil to basophil ratio and Neutrophil to lymphocyte ratio. [From Base line Day 0 to day 56]
Change in the levels of Eosinophil to basophil ratio and Neutrophil to lymphocyte ratio within specified range
- Oxidative Stress as assessed by Malondialdehyde concentration. [From Base line Day 0 to day 56]
malondialdehyde concentration of the samples will be measured as an index of lipid peroxidation
Eligibility Criteria
Criteria
Inclusion Criteria:
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Healthy, adult female participants aged ≥ 30 and ≤ 55 years.
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Participants with signs of poor skin barrier as determined by Trans-epidermal water loss ≥ 15 g/m2/h on forehead.
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Participants with skin type II to IV as per Fitzpatrick skin type calculator.
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Participants with skin type II and III as per Glogau's classification of photoageing skin.
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Participants must have Body Mass Index (BMI) ≥ 18.5 ≤ 29.9 kg/m2.
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Participants with moderate signs of Melasma as assessed by the investigators.
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Participants ready to abstain from any cosmetic or drug-based cream, ointment, lotion and other products apart from the ones allowed during study period.
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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:
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Unwilling to forgo any aesthetic or dermatological treatments or procedures during the study period.
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Participants with visible scarring on face.
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Participants having any form of skin disorder on the Nasolabial fold.
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Water consumption history of ≤ 500 ml and ≥ 3000 ml per day.
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Smoking or using any tobacco products.
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Participants presently undergoing or had undergone treatment for softening or reducing wrinkles in the last 3 months.
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Having a history of chronic skin allergies.
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History of heavy caffeine usage ≥ 4 cups in a day.
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Binge drinkers as defined by consumption of 4 or more alcohol containing beverages within 2 hours.
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Presence of unstable, acutely symptomatic, or life-limiting illness.
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Participants taking any vitamins and other related supplements.
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Menopausal and peri-menopausal females.
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Females who are pregnant/planning to be pregnant/lactating or taking any oral contraceptives.
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Females who have had participated in a study of an investigational product 90 days prior to the screening.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Skin cure and care clinic | Thāne | Maharashtra | India | 400602 |
Sponsors and Collaborators
- Vedic Lifesciences Pvt. Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MGB/191101/BFKE/SKNM