A Single-center, Prospective, Open Labeled, Phase IV Clinical study to evaluate safety and efficacy of MyV3 HERBAL Face care pack in patients to reduced Black spot, blemishes, pimples, scars and skin tan. - NI

MS Vee Herbal Care Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年5月27日

试验速览

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•1)Male/females of = 18 years of age at the time of consent
•2)Patient / Legally Acceptable Representative who can and willing to provide Informed Consent
•3)Facial redness associated with rosacea with or without bumps or blemishes
•4)Facial redness (IGA-R) score of 2 or 3 (i.e., mild or moderate)
•5)IGA score of 2 or 3 (i.e., mild or moderate).
•6)Willing to forego any other topical or non-topical treatment on the study areas during treatment (other than sun protection or the study specified face wash and moisturizer)
•7)Willing to use the provided skincare regimen (e.g., face wash and moisturizer) over the duration of the study
•8)Absence of any skin conditions that could interfere with the visual erythema assessments
•9)Subjects who are willing to be photographed and video-recorded during study visits and willing to sign photographic release forms

•1)Known hypersensitivity or previous allergic reaction to any constituent of the Investigational Products (i.e., essential oils, fragrance, choline, phosphatidylcholine, etc.)
•2)History or presence of a skin condition/disease that is located in the treatment area(s) and might interfere with the diagnosis or evaluation of study parameters (i.e., atopic dermatitis, psoriasis, significant actinic damage, vitiligo, open wounds, infection, etc.)
•3)Uncontrolled systemic disease
•4)Any transient flushing syndrome.
•5)History of basal cell carcinoma within 6 months of Visit 1
•6)Foreseen unprotected and intense/excessive UV exposure during the course of the study
•7)Use of any of the following concomitant medications/procedures:
•a)Cosmetic and/or OTC products for redness reduction and/or skin
•b)Topical medications for rosacea
•c)Systemic antibiotics or corticosteroids
•d)Topical antibiotics, corticosteroids, or antiparasitic agents
•e)Intense/excessive ultraviolet (UV) radiation
•f)Phototherapy, energy-based therapy, facials, chemical peels, microdermabrasion
•8)Exposure to any other investigational drug/device within 30 days prior to study entry.

发起方

MS Vee Herbal Care Pvt Ltd