A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy of Blue Fenugreek Kale Extract (BFKE) on Skin.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Vedic Lifesciences Pvt. Ltd.
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Trans Epidermal Water Loss (TEWL) using Tewameter®.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 30 Years to 55 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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/m
- •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.
Arms & Interventions
Blue fenugreek kale extract
One capsule to be taken orally before breakfast and one capsule after lunch, with water.
Intervention: Blue fenugreek kale extract (Other)
Placebo
One capsule to be taken orally before breakfast and one capsule after lunch, with water.
Intervention: Placebo (Other)
Outcomes
Primary Outcomes
Trans Epidermal Water Loss (TEWL) using Tewameter®.
Time Frame: 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®.
Modified Fitzpatrick Wrinkle Severity Scale
Time Frame: 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.
Allergic skin inflammation as assessed by Eosinophil to basophil ratio and Neutrophil to lymphocyte ratio.
Time Frame: 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.
Time Frame: From Base line Day 0 to day 56
malondialdehyde concentration of the samples will be measured as an index of lipid peroxidation
Ezure Sagging scale
Time Frame: 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
Time Frame: From Base line Day 0 to day 56
A decrease in pinch recoil time is associated with improvement in skin elasticity/firmness.
Investigator's global assessment using 5-point Likert scale
Time Frame: 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
Time Frame: 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
Time Frame: From Base line Day 0 to day 56
Change in the levels of Inflammatory biomarkers within specified range
Skin moisture
Time Frame: From Base line Day 0 to day 56
skin hydration as measured by skin moisture (forehead \& forearm) using skin moisture analyzer.
Skin parameters using a participant based self-assessment questionnaire
Time Frame: From Base line Day 0 to day 56
Highest Score represents Better and lowest Score represents Worst
Secondary Outcomes
No secondary outcomes reported