Health Condition 1: R238- Other skin changes
Conditions
Interventions
Intervention1: Stretchmark Oil: Approx. 3 gm of test product to be applied on the abdominal scar area and arms /thighs /buttocks /chest in a similar way.
Product to be used twice daily for a period o
Sponsors
Zydus Wellness Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1)Dermatological assessment of abdominal scar using the Patient/subject and Observer Scar Assessment scale (POSAS) and Vancouverâ??s Scar Scale (VSS). 2)Assessment of skin elasticity and firmness of abdominal area using Cutometer. 3)Dermatological assessment of prevention of abdominal scar using the Vancouverâ??s Scar Scale (VSS). 4)Assessment of hair fall reduction using 60-s Hair count technique. 5)Dermatological assessment of Hair Strength using Pull test.Timepoint: Baseline, Day 5, Day 15, Day 30 and Day 60 | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of % anagen hairs, percent telogen hairs and A:T ratio using â??Hair Pluck Testâ?? and Microscopic Evaluation.Timepoint: Baseline, Day 5, Day 15, Day 30 and Day 60;Assessment of abdominal scar measurement using Digital Vernier Calipers.Timepoint: Baseline, Day 5, Day 15, Day 30 and Day 60;Assessment of oiliness of scalp using Sebumeter.Timepoint: Baseline, Day 5, Day 15, Day 30 and Day 60;Assessment of scalp condition using Phototrichogram by CASlite Nova.Timepoint: Baseline, Day 5, Day 15, Day 30 and Day 60;Dermatological assessment of appearance of scalp skin.Timepoint: Baseline, Day 5, Day 15, Day 30 and Day 60;Dermatological assessment of general appearance of hair.Timepoint: Baseline, Day 5, Day 15, Day 30 and Day 60;Dermatological assessment of scar using Goodman & Baronâ??s scales classification.Timepoint: Baseline, Day 5, Day 15, Day 30 and Day 60;Digital photographs of stretchmarks and hair/scalp.Timepoint: Baseline, Day 5, Day 15, Day 30 and Day 60;Subject Satisfaction Questionnaire and Product Response Index (Perception about Product).Timepoint: Baseline, Day 5, Day 15, Day 30 and Day 60 | — |
Countries
India
Contacts
Public ContactDr Simran Sethi
Cliantha Research
Outcome results
None listed