An open-label, single-arm study to evaluate the efficacy and safety of a Nursing Gel in healthy pregnant female (3rd trimester) and lactating female (post pregnancy mother having 0 month to 3 months old baby) subjects with sore & cracked nipples.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1)Gynecological assessment of nipple soreness/pain using visual analogue scale (VAS).
研究概览
简要总结
The potentialsubjects will be screened as per the inclusion and exclusion criteria onlyafter obtaining written informed consent from the subjects.
There are total 4 visits in the study i.e.
· Visit 01:Screening Visit (within 30 days prior to day 01)
· Visit 02:Enrollment (Day 01)
· Visit 03:Evaluation phase (Day 02 + 1 day)
· Visit 04:Evaluation phase and End of the study (Day 14 ± 2 days)
Beforeentering the facility, at security check-post, subjects will be asked forpre-entry scrutiny check for COVID-19 symptoms. Study can be conducted inmultiple batches (set of subjects) in order to follow the norms of covid-19restrictions.
Instrumentalassessment, dermatological assessments and questionnaires will be assessed.Safety will be assessed throughout the study by monitoring of adverse events.
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
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •Sex: Females, either of the following a.Healthy pregnant females (3rd trimester).
- •b.Lactating females (post pregnancy mothers having 0 to 3 months old baby).
- •Subjects with mild to moderate nipple soreness/pain based on visual analogue scale (VAS).
- •For Post Pregnancy Mothers: Subjects having history of delivery within 42 weeks.
- •For Pregnant females: Primipara (woman who is giving birth for the first time) subjects, who are diagnosed as pregnant female by gynaecologist.
排除标准
- •Subjects having contraindications for breastfeeding 2)Newborn with no oral, palatal or maxillofacial abnormalities.
- •Subjects with history of development of any breast problem: Mastitis, engorgement etc.
- •Subjects not willing to discontinue other nipple crack preventing method during application.
- •Subjects who are not taking any pain management medication e.g., NSAID’s, pain killers, etc.
- •Participation in a similar clinical study within the previous 90 days.
结局指标
主要结局
1)Gynecological assessment of nipple soreness/pain using visual analogue scale (VAS).
时间窗: Baseline, Day 02, Day 14
2)Dermatological assessment of nipple skin dryness, nipple skin roughness, nipple skin redness/erythema, burning, itching, stinging using 5-point scoring scale.
时间窗: Baseline, Day 02, Day 14
次要结局
- Digital Photographs of the nipple and surrounding area(Baseline, Day 02, Day 14)
- Subject Satisfaction Questionnaire and Product Response Index (Perception about Product).(Baseline, Day 02, Day 14)
- Assessment of skin hydration using Corneometer /Moisturemeter SC.(Baseline, Day 02, Day 14)
- Assessment of skin barrier function using TEWAmeter /Vapometer.(Baseline, Day 02, Day 14)