An open label clinical study to evaluate the Safety, Tolerability and In-useefficacy of HBWW-052005

Himalaya Wellness Company0 个研究点目标入组 84 人开始时间: 待定最近更新: 2023年5月29日

试验速览

暂无简介。

•1.Healthy subjects in the age group as below (inclusive of both genders)
•a.Group 1: >=18-<=45 years (both inclusive)
•b.Group 2: >= 2 - -<=12 years (both inclusive)
•c.Group 3: 0 months â?? -<=2 years (both inclusive)
•d.Group 4: Premature babies (babies born before 37 weeks)
•2.Healthy day 1 babies not requiring medical attention.
•3.Babies with signs of atopic dermatitis (dry skin, itchy skin, redness, sensitive skin, rashes) who does not require medical/systemic treatment to be included. Included in group 2 (6 subjects) and group 3 (15 subjects) with signs of atopic dermatitis.
•4.Subjects in general good health as determined from a recent medical history.
•5.Subjects mother/legal representative, preferably mother willing to give a voluntary written informed consent and agree to come for regular follow up.
•6.Subjects mother/legal representative, preferably mother willing to abide by and comply with the study protocol.
•7.Subjects should not participate in any other clinical study during participation in the current study.

•1.A known history or present condition of allergic response to any other concern that may require medical attention.
•2.Chronic illness which may influence the cutaneous state.
•3.Subjects not willing to stop the use of other baby powders during the study period.
•4.Subjects participated in any other clinical study past 4 weeks
•5.To determine the experience of test product on baby skin through subjective questionnaires on cleaning as pure as water, gentle cleansing without making skin dry for new-born skin, Suitable/ safe for newborn skin, suitable for sensitive skin babies, safe for use from day 1 of the baby, suitable/ safe for premature baby. keeps skin refreshed, keeps baby skin soft and smooth, mildness and gentleness tested in babies and safe on new-born
•6.Local tolerance evaluation by the investigator.
•7.Monitoring of AEs and SAEs

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