CTRI/2023/12/060577CompletedPhase 2
To evaluate the efficacy of the test product in comparison to baseline in improving hair growth rate and hair fall reduction in healthy female subjects
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Marico Limited
- Enrollment
- 38
- Locations
- 1
- Primary Endpoint
- assessment of reduction in hair fall, hair growth rate, hair density, thickness
Study Overview
Brief Summary
Adult female subjects with age between 18-45 years (both inclusive) will be screened for eligibility criteria. On screening visit, before starting any study procedure, written informed consent will be obtained.
All baseline assessment like baseline dermatological assessments and imaging will be performed. Post baseline assessments, the selected subjects will be provided with the test product. The subjects will be instructed to use the test product for 90/92 days.
Follow up evaluations will be performed at day 14 & 16, day 30 & 32, day 60 and 62 and day 90 & 92.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 45.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •Female subjects in general good health. 2)Subjects in the age group 18-45 years (both the ages inclusive). 3)Subjects complaining of hair fall and damage. 4)Subjects willing to give a written informed consent and willing to abide by and comply with the study protocol. 5)Hair density of >100 and <200 hair follicle per square cm as per Trichoscan measurement 6)Female subjects falling under Grade
- •Grade 6 of hair loss severity grade evaluated as per MSCR photo numerical 10-point scale (Linear scale for assessment purpose-In use Scale).
Exclusion Criteria
- •Subjects who have undergone hair growth treatment within 3 months before screening into the study.
- •Subjects having any active scalp disease which may interfere in the study – dermatologist’s judgement.
- •Subjects who have taken chemotherapy for cancer in the 6 months prior to start of the study or have a plan to do treatments during study.
- •Subjects who have history of alcoholism, smoking, crash dieting and/ or psychiatric disorder including trichotillomania.
- •Subjects who have had hair transplant, who have taken pharmaceutical product which cause hirsutism (ex.
- •phenytoin) and finasteride for androgenic alopecia, under medical treatment for hair problems.
- •A known history or present condition of allergic response/hypersensitivity to any cosmetic ingredients and pharmaceutical products.
- •Subjects on oral medications, undergoing any chemical hair salon treatment-straightening / perming / colour/ henna which will compromise the study.
- •Subjects with chronic illness which may influence the cutaneous state.
- •Subjects participating in other similar cosmetic or therapeutic trial within last three months.
- •Subjects with any history of underlying uncontrolled medical illness including diabetes mellitus, hypertension, HIV, hepatitis, severe anemia, serious disorder of heart and respiratory apparatus or any other serious medical illness.
Outcomes
Primary Outcomes
assessment of reduction in hair fall, hair growth rate, hair density, thickness
Time Frame: Day 1, 14, 30 , 60 and 90
Secondary Outcomes
- NA(NA)
Investigators
Dr Mukesh Ramnane
MS Clinical Research Pvt Ltd
Study Sites (1)
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