A prospective, open label clinical trial to evaluate the efficacy and safety of Tubby nutririch lotion for the treatment of dry skin with or without Atopic tendency in infants and children.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- •Change from Baseline in the EASI (Eczema Area Severity Index) Score [All visits].
研究概览
简要总结
It is a prospective clinical trial toevaluate the efficacy and safety of Tubby nutririch lotion for the treatment ofdry skin with or without Atopic tendency in infants and children.
The objectives of the study are
Primary objectives**:**
To evaluate theefficacy of Tubby nutririch lotionin infants and children with dryskin.
Secondary objectives:
To evaluate the safety of Tubby nutririch lotionin infants and children with dryskin.
During the screeningvisit & visit 1 (Day -3 toDay 1), insistentexplanation to the patients and instructions will be done. Then handing over of patient consent form, patientinformation form to obtain written consent from the parents will be done. Thensubject Id is given to the subject.
Baseline Assessmentswill be done using the EASI questionnaire. Skin assessments will be done formoisture content (skin hydration) and trans-epidermal water loss. Quality oflife is assessed using The Infant’sDermatitis Quality of Life Index (IDQOL) or CDQOL and Dermatitis FamilyImpact Questionnaire (DFI).Then the IP is dispensed and determine the next dateof visit.
DuringVisit 2 ( Day 7 ± 1) and Visit 3(Day 14 ± 1) the procedures that are done are recording of AEs, Concomitant Medications, Issueof diary card, Investigator/subject evaluation using questionnaire and Determinethe next date of visit. EASI questionnaire assessment will be done.
During the Visit 4 (final visit-Day 28 ± 1) Assessments will bedone using the EASI questionnaire. Assessments for skin moisture content andtrans-epidermal water loss. Quality of life is assessed using The Infant’s Dermatitis Quality of Life Index(IDQOL), CDQOL and Dermatitis Family Impact Questionnaire (DFI)
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 6.00 Month(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •â€¢Children between 6 months to 12 years of age •Parents willing to provide written informed consent/assent •Diagnosed as having dry skin with or without mild to moderate atopic tendency.
排除标准
- •â€¢Patient has clinically infected atopic dermatitis at baseline.
- •â€¢Patient with known hypersensitivity in general, to study drug or any excipients of the product •Any dermatological condition other than atopic dermatitis that in the Investigators opinion may interfere with the evaluation of the patients atopic dermatitis •Patients using non-sedating histamines least 7 days prior to the first dosing day or throughout the study.
- •â€¢Severe Atopic Dermatitis •History of other skin disorders, that could interfere with the evaluations •Use of any topical treatment known or suspected to have an effect on atopic dermatitis within one week prior to the screen visit (except for calcineurin inhibitors, for which the washout is 2 weeks) •Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study •Use of any other investigational agent in the last 30 days.
结局指标
主要结局
•Change from Baseline in the EASI (Eczema Area Severity Index) Score [All visits].
时间窗: Base line and Week 4
•Investigator global evaluation [Base line and Week 4]
时间窗: Base line and Week 4
•Change in Moisture content and trans-epidermal water loss from baseline [Base line and Week 4]
时间窗: Base line and Week 4
次要结局
- •Quality of life by using IDQOL and DFI, CDQOL [Base line and Week 4](•Investigator/Patient LAR/patient evaluation (All visits) for Comedogenic, Photosensitivity and hypoallergenicity)