Skin HealthNCT04544982
Study to Evaluate the Efficacy of Blue Fenugreek Kale Extract (BFKE) on Skin
A study testing Blue fenugreek kale extract in people with Skin Health, run by Vedic Lifesciences Pvt. Ltd. at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Skin Health
- What is being tested?
- Blue fenugreek kale extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIndia
- Study dates
- 1 Sep 2020to 25 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Skin Health
- Being tested
- Blue fenugreek kale extract, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blue fenugreek kale extractOther
One capsule to be taken orally before breakfast and one capsule after lunch, with water.
PlaceboOther
One capsule to be taken orally before breakfast and one capsule after lunch, with water.
| Study group | Role | What they receive |
|---|---|---|
| Blue fenugreek kale extract | Active comparator | One capsule to be taken orally before breakfast and one capsule after lunch, with water. Receives: Other: Blue fenugreek kale extract |
| Placebo | Placebo comparator | One capsule to be taken orally before breakfast and one capsule after lunch, with water. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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®.
Measured: From Base line Day 0 to day 56
Skin moisture
skin hydration as measured by skin moisture (forehead \& forearm) using skin moisture analyzer.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: From Base line Day 0 to day 56
Inflammatory biomarkers
Change in the levels of Inflammatory biomarkers within specified range
Measured: 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
Measured: 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
Measured: From Base line Day 0 to day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2020
- Study start1 Sep 2020
- Primary completion30 Jan 2021
- Study completion25 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04544982
- Sponsor's protocol ID
- MGB/191101/BFKE/SKNM
- Status last verified
- Sep 2020
- First submitted
- 26 Aug 2020
- Last updated
- 6 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy of Blue Fenugreek Kale Extract (BFKE) on Skin.
- ClinicalTrials.gov ID
- NCT04544982
- Acronym / sponsor ID
- MGB/191101/BFKE/SKNM
- Conditions
- Skin Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 30 Jan 2021 (actual)
- Study completion
- 25 Mar 2021 (actual)
- First posted
- 10 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blue fenugreek kale extract | Active comparator | Other: Blue fenugreek kale extractOne capsule to be taken orally before breakfast and one capsule after lunch, with water. |
| Placebo | Placebo comparator | Other: PlaceboOne capsule to be taken orally before breakfast and one capsule after lunch, with water. |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blue fenugreek kale extractOne capsule to be taken orally before breakfast and one capsule after lunch, with water. | Other | Blue fenugreek kale extract |
| PlaceboOne capsule to be taken orally before breakfast and one capsule after lunch, with water. | Other | Placebo |
Primary outcome
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®.
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.
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.
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
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.
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
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.
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.
Inflammatory biomarkers
Time frame: From Base line Day 0 to day 56
Change in the levels of Inflammatory biomarkers within specified range
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blue fenugreek kale extract in people with Skin Health, run by Vedic Lifesciences Pvt. Ltd. at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trans Epidermal Water Loss (TEWL) using Tewameter®. (time frame: From Base line Day 0 to day 56). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2021.