Clinical study to evaluate the safety and efficacy of Stretchmark Oil & Oil Free Hair Oil in healthy pregnant females and lactating females.
- Conditions
- Health Condition 1: R238- Other skin changes
- Registration Number
- CTRI/2022/08/044605
- Lead Sponsor
- Zydus Wellness Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 53
1)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).
2)Subjects having stretch mark on their abdomen at the time of enrollment.
3)Atleast 12 healthy pregnant females (1st and 2nd trimester) without stretchmarks will be enrolled.
4)Subjects complaining of having at least 50 to 100 hair fall per day.
5)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.
6)For Post Pregnancy Mothers: Subjects having history of delivery within 42 weeks.
7)For Pregnant females: Primipara (woman who is giving birth for the first time) subjects, who are diagnosed as pregnant female by gynaecologist.
1)Subjects with a history of severe hair fall due to any clinically significant problems/s like anaemia, thyroid problems etc.
2)History of any dermatological condition of the scalp other than hair loss and/or dandruff.
3)History or present condition of irritated or visibly inflamed scalp or severe scalp disease.
4)Skin disease (e.g., moderate to severe acne vulgaris face or nodulocystic acne, psoriasis, atopic dermatitis or any other condition as per Investigatorâ??s discretion), which would interfere with the test readings.
5)Participation in a similar clinical study within the previous 90 days.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1)Dermatological assessment of abdominal scar using the Patient/subject and Observer Scar Assessment scale (POSAS) and Vancouverâ??s Scar Scale (VSS). <br/ ><br>2)Assessment of skin elasticity and firmness of abdominal area using Cutometer. <br/ ><br>3)Dermatological assessment of prevention of abdominal scar using the Vancouverâ??s Scar Scale (VSS). <br/ ><br>4)Assessment of hair fall reduction using 60-s Hair count technique. <br/ ><br>5)Dermatological assessment of Hair Strength using Pull test.Timepoint: Baseline, Day 5, Day 15, Day 30 and Day 60
- Secondary Outcome Measures
Name Time Method