Clinical validation of natural plant based skincare supplement
- Registration Number
- CTRI/2020/06/025644
- Lead Sponsor
- Climic Health Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Male/ Female of 18 to 40 years, willing to give a written informed consent and come for regular observations
Subject is a healthy adult, female, in the age range of 18 and 40 years
Subject with dull complexion, dry/oily skin with/ without uneven texture and with at least 2 hyperpigmentary spots as a result of photodamage.
Mild acne without nodular abscesses
Subject has not participated in a similar clinical investigation in the past three months.
Subject who is willing to abstain from using any fairness product, sunscreens, natural/ Ayurvedic treatments or other home remedies and also willing to abstain from undergoing any facial treatments such as facial masks, packs, bleaching, etc either at home or at beauty parlour during the entire study course. In case of having used fairness product in the near past, should be willing to undergo a wash out period of 1 week, wherein they should abstain from applying any product other than the suggested cleanser on face.
Female subjects of reproductive age group should undergo
Subject with a known history or present condition of allergic response to any cosmetic/pharmaceutical products, toiletries or their ingredients including fragrance.
Subject who has used any systemic medication (antibiotics, retinoid, steroids, spironolactone or any anti acne medication) within past 4 weeks or any topical facial medication within 2 weeks prior to study commencement, which could compromise the study.
Subject with a medical history of disease or condition or a concurrent illness or pre- existing or dormant dermatologic condition (psoriasis, rosacea, rashes, eczema etc.) that could interfere with the study results.
Subject with excessive facial hair or scars, which could interfere with evaluation. Subject with a history of having used a similar product during or since 1 week prior to the scheduled study commencement.
Subject who is currently pregnant (as confirmed by the urine pregnancy test) or nursing or contemplating pregnancy during the study course.
Subject who has used any systemic medication (antibiotics, oral contraceptive pills, retinoid, steroids, spironolactone or any anti acne medication) within past 4 weeks or any topical facial medication within 2 weeks prior to study commencement, which could compromise the study.
Subject with a medical history of disease or condition or a concurrent illness or pre- existing or dormant dermatologic condition (psoriasis, rosacea, rashes, eczema etc.) that could interfere with the study results.
Patient with known history of acute / chronic liver or kidney disease.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To Study the efficacy in reducing hyper pigmentation, dark spots/ circles and redness by MASI scoring, reduction in acne lesion counts as per modified MASI scoring <br/ ><br>To study subjective efficacy parameters using 10â??cm VAS for the improvements in skin complexion and evenness by investigator <br/ ><br>Global Assessment Grade for improvement in complexion / dark spots on the face <br/ ><br>Timepoint: Baseline visit (day 0), Visit I (day 15), Visit II (day 30), Visit III (day 60) Visit IV (Day 90)
- Secondary Outcome Measures
Name Time Method Assessment of tolerability of study drug by assessing adverse events, serious adverse events during the study period. <br/ ><br>Assessment of Global evaluation of overall improvement in complexion on the face and neck by investigator and subject. <br/ ><br>Assessment of digestive behaviour after treatment of product <br/ ><br>Timepoint: Baseline visit (day 0), Visit I (day 15), Visit II (day 30), Visit III (day 60), Visit IV (Day 90)