CTRI/2025/11/098010招募中不适用
A Multi-Center Clinical Evaluation of Efficacy of Baby Wash and Baby Moisturizing Cream in the Management of Mild to Moderate Atopic Dermatitis in Infants, Toddlers and Children in India.
JNTL Consumer Health (India) Private Limited (Kenvue, India)3 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年12月6日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 3
研究概览
简要总结
Atopic dermatitis (AD) is a most common inflammatory skin condition of eczema that affects a significant number of infants, toddlers, and children in India. Characterized by dry, itchy, and inflamed skin, AD leads to discomfort, sleep disturbances, and a compromised quality of life for both affected children and their families.
The IPs in this study, a Baby Moisturizing Wash and a Baby Moisturizing Cream, contain a formulation enriched with triple oat, known for its hydrating and soothing properties. Previous studies have shown these products to be beneficial for sensitive and eczema-prone skin. However, there is a need for robust clinical data to substantiate their efficacy and safety specifically in the Indian pediatric population.
This clinical trial aims to evaluate the efficacy and safety of the Baby Moisturizing Wash and Baby Moisturizing Cream in infants, toddlers, and children diagnosed with atopic dermatitis across different geographical locations with distinct climatic condition in India. By conducting this study, we seek to provide critical evidence that will not only support the continued use of these products but also contribute to enhancing the overall management of atopic dermatitis in young children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 3.00 Month(s) 至 6.00 Year(s)（—）
- 性别
- All
入选标准
- •For both Non-steroid and Steroid using group
- •Male/Female
- •Participants between the age of 3 months to 6 years.
- •Has mild to moderate atopic dermatitis with at least 1 target lesion based on the ADSI with a score from 2 to 8.5 and an erythema sub score of at least 2 (moderate).
- •Has parent-assessed history of itch, scoring from 2 to 4 in Caregivers Itch Assessment scale (CIA).
- •Has parent-perceived sensitive skin.
- •Generally, in good health based on medical history reported by the participant.
- •For Non steroid using group
- •Participant who reported to have atopic dermatitis for the first time can also be included
- •Participants with a treatment-free period for treatment: injectable corticosteroids: 60 days, systemic corticosteroids: 30 days, topical corticosteroids: 30 days, topical immunomodulators: 30 days, antihistaminic: 15 days For Steroid using group
- •Participants who are currently using low potency topical steroids or participants who are required to start low potency topical steroids.
- •Must have been on a stable dose of topical corticosteroids (Class IV to VII).
- •Patient with a treatment-free period for: injectable corticosteroids: 60 days, systemic corticosteroids: 30 days, topical immunomodulator: 30 days, antihistaminic: 15 days Parent Only
- •18-65 years of age
- •Literate (Able to read, write, speak English/ Kannada/Tamil/ Hindi)
- •Willing to replace the participant’s current body wash with the investigational wash and apply the investigational cream as instructed throughout the study.
- •Has a smart phone capable of receiving text messages and accessing the internet and agree to complete questionnaires via text message.
- •Intends to successfully complete the study and is willing and able to follow the participant responsibilities.
- •Prior to Baseline and during the study: willing to stop all emollients, moisturizers and/or other skin barrier cream or emulsion treatments for the Atopic dermatitis condition for the washout period and for the study duration; willing to stop all face and body wash products for washing the child during the study.
- •For medicated group: Must be aware of the child participant’s previous history of steroid treatment.
排除标准
- •Child (includes infants, toddlers, and children) and Parent:
- •Patients with asthma/food allergy.
- •Presents with a health condition and/or pre-existing acute or chronic dermatologic conditions (e.g., psoriasis, rosacea, rashes, many and/or severe excoriations, etc.) that could interfere with the outcome of the study or be deemed inappropriate for study participation as determined by the PI.
- •Has known allergies or adverse reactions to common topical skincare products or ingredients of the IPs.
- •Has self-reported Type 1 or Type 2 diabetes or is taking insulin or another anti-diabetic medication.
- •Is taking medications that would mask an AE or influence the study results, for all participants and all parents including: Immunosuppressive drugs or steroidal (Class I, II, III) drugs within 2 weeks before Visit 1 and during the study; non-steroidal anti-inflammatory drugs within 5 days before Visit 1 and during the study; Antihistamines within 2 weeks before Visit 1 and during the study; Other prescription or OTC medications, that may interfere with study evaluations (use of acetaminophen and/or ibuprofen as needed is acceptable if it was instructed by the child’s pediatrician).
- •If an individual is taking one of these medication types, the individual is not considered eligible at screening.
- •However, if a participant begins using one of these medications during the study, the Study PI should be consulted to consider the impact of the specific medication on participant safety and/or the study results as described in Concurrent/Concomitant Medication.
- •Has a history of or a concurrent health/other condition/situation which may put the individual at significant risk, confound the study results, or interfere significantly with the individual’s participation in the study.
- •Is an employee/contractor or household family member of the PI, Study Site, or Sponsor.
- •Is simultaneously participating in any other clinical study or has participated in another clinical study in the past 30 days.
- •Parent only:
- •Is self-reported to be pregnant or planning to become pregnant during the study.
研究者
Dr Mukta Sachdev
MS Clinical Research Pvt. Ltd
研究点 (3)
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