Clinical trial NCT04544982: Study to Evaluate the Efficacy of Blue Fenugreek Kale Extract (BFKE) on Skin
Official title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy of Blue Fenugreek Kale Extract (BFKE) on Skin.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Health
Lead sponsor: Vedic Lifesciences Pvt. Ltd.
Sponsor class: INDUSTRY
First posted: 2020-09-10
Enrollment: 60
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Trans Epidermal Water Loss (TEWL) using Tewameter®.
timeFrame: From Base line Day 0 to day 56
measure: Skin moisture
timeFrame: From Base line Day 0 to day 56
measure: Modified Fitzpatrick Wrinkle Severity Scale
timeFrame: From Base line Day 0 to day 56
measure: Ezure Sagging scale
timeFrame: From Base line Day 0 to day 56
measure: Pinch recoil test
timeFrame: From Base line Day 0 to day 56
measure: Skin parameters using a participant based self-assessment questionnaire
timeFrame: From Base line Day 0 to day 56
measure: Investigator's global assessment using 5-point Likert scale
timeFrame: From Base line Day 0 to day 56
measure: Participant's global assessment using 5-point Likert scale
timeFrame: From Base line Day 0 to day 56
measure: Inflammatory biomarkers
timeFrame: From Base line Day 0 to day 56
measure: Allergic skin inflammation as assessed by Eosinophil to basophil ratio and Neutrophil to lymphocyte ratio.
timeFrame: From Base line Day 0 to day 56
measure: Oxidative Stress as assessed by Malondialdehyde concentration.
timeFrame: From Base line Day 0 to day 56
Secondary outcomes:
Other outcomes:
Locations:
city: Thāne
country: India
facility: Skin cure and care clinic
state: Maharashtra
Study officials:
References: