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Completed

NCT Number: NCT04544982

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.

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Key information

Conditions

Skin Health

Age range

30 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Skin cure and care clinic

Thane, Maharashtra, 400602, India

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Blue fenugreek kale extract

Other

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

Placebo

Other

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

Primary outcomes

  1. 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®.

  2. 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.

  3. 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.

  4. 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

  5. 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.

  6. 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

  7. 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.

  8. 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.

  9. Inflammatory biomarkers

    Time frame: From Base line Day 0 to day 56

    Change in the levels of Inflammatory biomarkers within specified range

  10. 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

  11. 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

Sponsors and collaborators

Lead sponsor

Vedic Lifesciences Pvt. Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 10, 2020
Registry last updated
Apr 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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