CTRI/2023/12/060577
Completed
Phase 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 - NI
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Marico Limited
- Enrollment
- 36
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\)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 3 \- 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
- •1\) Subjects who have undergone hair growth treatment within 3 months before screening into the study.
- •2\) Subjects having any active scalp disease which may interfere in the study – dermatologist’s judgement.
- •3\) 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.
- •4\) Subjects who have history of alcoholism, smoking, crash dieting and/ or psychiatric disorder including trichotillomania.
- •5\) 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.
- •6\) A known history or present condition of allergic response/hypersensitivity to any cosmetic ingredients and pharmaceutical products.
- •7\) Subjects on oral medications, undergoing any chemical hair salon treatment\-straightening / perming / colour/ henna which will compromise the study.
- •8\) Subjects with chronic illness which may influence the cutaneous state.
- •9\) Subjects participating in other similar cosmetic or therapeutic trial within last three months.
- •10\) 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
Not specified
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