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

NCT04544982 | Completed

• 1 other identifier: MGB/191101/BFKE/SKNM
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Skin Health

Outcome Measures

Primary Outcomes (11)

• 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

Study Arms (2)

Blue fenugreek kale extract

ACTIVE COMPARATOR

One capsule to be taken orally before breakfast and one capsule after lunch, with water.

Other: Blue fenugreek kale extract

Placebo

PLACEBO COMPARATOR

One capsule to be taken orally before breakfast and one capsule after lunch, with water.

Other: Placebo

Interventions

Blue fenugreek kale extract OTHER

One capsule to be taken orally before breakfast and one capsule after lunch, with water.

Blue fenugreek kale extract

Placebo OTHER

One capsule to be taken orally before breakfast and one capsule after lunch, with water.

Placebo

Eligibility Criteria

• Age: 30 Years - 55 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vedic Lifesciences Pvt. Ltd.: lead

Study Sites (1)

Skin cure and care clinic

Thane, Maharashtra, 400602, India

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2020
• First Posted: September 10, 2020
• Study Start: September 1, 2020
• Primary Completion: January 30, 2021
• Study Completion: March 25, 2021
• Last Updated: April 6, 2021

Record last verified: 2020-09

Locations

IN (1)