An open-label, single-arm study to evaluate the efficacy and safety of a Stretchmark Oil & Oil Free Hair Oil in healthy pregnant female (1st and 2nd trimester) and lactating female (post pregnancy mother having 0 month to 3 months old baby) subjects.
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)Dermatological assessment of abdominal scar using the Patient/subject and Observer Scar Assessment scale (POSAS) and Vancouver’s Scar Scale (VSS).
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 6 visits in the study i.e.
· Visit 01: Screening Visit (within 30days prior to day 01)
· Visit 02: Enrollment (Day 01)
· Visit 03: Evaluation phase (Day 5)
· Visit 04: Evaluation phase (Day 15)
· Visit 05: Evaluation phase (Day 30)
· Visit 06: Evaluation phase and End ofthe study (Day 60)
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
- 22.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •Sex: Females, either of the following a.Healthy pregnant females (1st and 2nd Trimester).
- •b.Lactating females (post pregnancy mothers having 0 to 3 months old baby).
- •Subjects having stretch mark on their abdomen at the time of enrollment.
- •Atleast 12 healthy pregnant females (1st and 2nd trimester) without stretchmarks will be enrolled.
- •Subjects complaining of having at least 50 to 100 hair fall per day.
- •Subjects with 50 counts of hair fall from hair combing method (60-sec hair count) at screening visit (if screening and enrollment on same day) or on enrollment day before test product application.
- •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 with a history of severe hair fall due to any clinically significant problems/s like anaemia, thyroid problems etc.
- •History of any dermatological condition of the scalp other than hair loss and/or dandruff.
- •History or present condition of irritated or visibly inflamed scalp or severe scalp disease.
- •Skin disease (e.g., moderate to severe acne vulgaris face or nodulocystic acne, psoriasis, atopic dermatitis or any other condition as per Investigator’s discretion), which would interfere with the test readings.
- •Participation in a similar clinical study within the previous 90 days.
结局指标
主要结局
1)Dermatological assessment of abdominal scar using the Patient/subject and Observer Scar Assessment scale (POSAS) and Vancouver’s Scar Scale (VSS).
时间窗: Baseline, Day 5, Day 15, Day 30 and Day 60
2)Assessment of skin elasticity and firmness of abdominal area using Cutometer.
时间窗: Baseline, Day 5, Day 15, Day 30 and Day 60
3)Dermatological assessment of prevention of abdominal scar using the Vancouver’s Scar Scale (VSS).
时间窗: Baseline, Day 5, Day 15, Day 30 and Day 60
4)Assessment of hair fall reduction using 60-s Hair count technique.
时间窗: Baseline, Day 5, Day 15, Day 30 and Day 60
5)Dermatological assessment of Hair Strength using Pull test.
时间窗: Baseline, Day 5, Day 15, Day 30 and Day 60
次要结局
- Dermatological assessment of scar using Goodman & Baron’s scales classification.(Baseline, Day 5, Day 15, Day 30 and Day 60)
- Assessment of abdominal scar measurement using Digital Vernier Calipers.(Baseline, Day 5, Day 15, Day 30 and Day 60)
- Assessment of scalp condition using Phototrichogram by CASlite Nova.(Baseline, Day 5, Day 15, Day 30 and Day 60)
- Assessment of % anagen hairs, percent telogen hairs and A:T ratio using ‘Hair Pluck Test’ and Microscopic Evaluation.(Baseline, Day 5, Day 15, Day 30 and Day 60)
- Dermatological assessment of general appearance of hair.(Baseline, Day 5, Day 15, Day 30 and Day 60)
- Assessment of oiliness of scalp using Sebumeter.(Baseline, Day 5, Day 15, Day 30 and Day 60)
- Dermatological assessment of appearance of scalp skin.(Baseline, Day 5, Day 15, Day 30 and Day 60)
- Subject Satisfaction Questionnaire and Product Response Index (Perception about Product).(Baseline, Day 5, Day 15, Day 30 and Day 60)
- Digital photographs of stretchmarks and hair/scalp.(Baseline, Day 5, Day 15, Day 30 and Day 60)