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

Vedic Lifesciences

Status

Completed

Conditions

Skin Health

Treatments

Other: Blue fenugreek kale extract

Other: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT04544982

MGB/191101/BFKE/SKNM

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

Female

Ages

30 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.