An Open-Label, Single-Arm Study to Evaluate Efficacy and Safety of Test Product i.e. Diaper Rash Ointment in Healthy Babies of 0 to 36 Months of Age
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- 1. To assess overall severity scoring scale change from baseline Day 01 before application to after test product application.
研究概览
简要总结
This study is proposed to evaluate and establish the benefits of thetest product on mildness, gentleness and non-irritability on baby’s skin andsoothes the baby’s skin, also determine the experience of faster relief from painof and keeps the baby’s skin moisturized, upon application relieving dryness,redness, oedema, urticaria and any other reactions. The proposed benefits areevaluated by the Paediatrics, subjective assessment questionnaire and instrumentalevaluation at Day 1, Day 2, Day 3, Day 7 and Day 14.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 0.00 Day(s) 至 36.00 Month(s)（—）
- 性别
- All
入选标准
- •Baby in the age group of 0 including newborn babies Day 1 to 36 months inclusive of both genders at the time of consent.
- •Baby generally in good health as determined from recent medical history.
- •Baby who wears diapers at least 12 hours per day.
- •Baby mother or legal representative, preferably mother willing to give a voluntary written parental informed consent and agree to come for regular follow up.
- •Baby mother or legal representative, willing to ensure that their child continues to wear their usual brand of diapers and will continue to clean their child during diaper changes using their usual products and method with the exception of ointments, lotions, creams, or powders during the trial.
- •Baby mother or legal representative willing to refrain from changing any other products whose use may have an effect on their childs skin condition during the trial example laundry detergents, fabric softeners, and products used to bath the child.
- •Baby mother or legal representative, preferably mother willing to abide by and comply with the study protocol.
- •Babies should not participate in any other clinical study during participation in the current study.
排除标准
- •Baby mother or legal caretaker not willing to stop the use of other baby body milk or lotion or cream or any other baby face or body moisturizing product during the study period.
- •Chronic illness which may influence the cutaneous state.
- •Babies currently being toilet trained.
- •Baby participating in a similar clinical study, currently or during the previous 30 days.
- •Any Baby, in the Investigators opinion not considered suitable for enrollment.
- •A known history or present condition of allergic response to any other concern that may require medical attention.
- •Babies with medical history past or present of significant dermatological diseases or conditions, such as atopy, psoriasis, eczema, vitiligo or other conditions known to alter skin appearance or physiologic response example porphyria, chronic urticaria, or sunburn, rashes.
结局指标
主要结局
1. To assess overall severity scoring scale change from baseline Day 01 before application to after test product application.
时间窗: 1. at Time 6 hour, 12 hours, 24 hours, Day 07 and Day 14 by Pediatrician. | 2. Day 01 before application to after test product application at Time 30 min, 1 hour, 2 hours, 4 hours, 6 hour, 12 hours, 24 hours, Day 07 and Day 14 | 3. Time 30 min, 1 hour, 2 hours, 4 hours, 8 hour, 12 hours, 24 hours, Day 07 and Day 14
2. To assess baby diaper rash skin in terms of mildness, gentleness, and non-irritability, erythema or redness, dryness, itching, rashes, oedema, pruritus, urticaria of babies’ skin by using pediatrician assessment by the consulting pediatrician
时间窗: 1. at Time 6 hour, 12 hours, 24 hours, Day 07 and Day 14 by Pediatrician. | 2. Day 01 before application to after test product application at Time 30 min, 1 hour, 2 hours, 4 hours, 6 hour, 12 hours, 24 hours, Day 07 and Day 14 | 3. Time 30 min, 1 hour, 2 hours, 4 hours, 8 hour, 12 hours, 24 hours, Day 07 and Day 14
3. To assess subjective self-assessment questionnaire after test product use.
时间窗: 1. at Time 6 hour, 12 hours, 24 hours, Day 07 and Day 14 by Pediatrician. | 2. Day 01 before application to after test product application at Time 30 min, 1 hour, 2 hours, 4 hours, 6 hour, 12 hours, 24 hours, Day 07 and Day 14 | 3. Time 30 min, 1 hour, 2 hours, 4 hours, 8 hour, 12 hours, 24 hours, Day 07 and Day 14
次要结局
- 1. To assess effect of test product on baby diaper rash skin for erythema using Mexameter® MX 18(2. To assess effect of test product on baby diaper rash skin for barrier function by transepidermal water loss (TEWL) using TEWAmeter® TM 300 or Vapometer)