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

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

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 Overview

• Status: Completed
• Conditions: Skin Health
• Intervention / Treatment: Other: Blue fenugreek kale extract; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Maharashtra
    • Thāne, Maharashtra, India, 400602
      • Skin cure and care clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Vedic Lifesciences Pvt. Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Actual): January 30, 2021
• Study Completion (Actual): March 25, 2021

Study Registration Dates

• First Submitted: August 26, 2020
• First Submitted That Met QC Criteria: September 3, 2020
• First Posted (Actual): September 10, 2020

Study Record Updates

• Last Update Posted (Actual): April 6, 2021
• Last Update Submitted That Met QC Criteria: April 5, 2021
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: MGB/191101/BFKE/SKNM

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No