None listed
Conditions
Interventions
Intervention1: LS/SC/OR/001: 1-2 capsules twice daily orally
for 90 days
Intervention2: LS/SC/TP/001: Apply sufficient amount of
product to entire face and neck with gentle round and upward massage
In
Sponsors
Life Synergy
Eligibility
Inclusion criteria
Inclusion criteria: Should possess at least two conditions mentioned below- Subject with dull complexion, with/ without uneven texture, at least 2 hyper pigmentary spots, Mild acne without nodular abscesses Facial mild Melasma on MASI score presence of mild under eye dark circles, Visible fine lines and/ or wrinkles, i.e., Glabellar frown lines/Crowâ??s feet/nasolabial folds/forehead lines and perioral wrinkles. 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.
Exclusion criteria
Exclusion criteria: 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. Pregnant and lactating mothers. Subject who has used any systemic 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Instrumental evaluation using 3D imaging by Visia CR system Wrinkles, Blemish, Pore volume and Porosity index, Skin Texture, Corneometer hydration, Vapometer TEWL skin barrier properties and trans epidermal water loss. Clinical evaluation of Wrinkles, Skin pore severity, Hyper pigmentation, dark spots, under eye circles, active or acne lesion and redness by MASI scoring, Skin moisture grading scaleTimepoint: From baseline to end of study ie day 90. | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical evaluation for tolerance, Patient Satisfaction Questionnaire, Hydration and moisture to the skin, Radiance of the skin by clinical scoring using the coloring, luminosity, brightness, and transparency scale and imperfections scale dark circles, redness, dark spots, and heterogeneity, Changes in hematological and biochemical parameters.Timepoint: From baseline to end of study ie day 90 | — |
Countries
India
Contacts
Public ContactMs Vaishnavi Padar
Mprex Healthcare Pvt Ltd
Outcome results
None listed