CTRI/2022/04/041710
Completed
未知
A Proof-Of-Concept, Safety and Efficacy study of Hair Fall Control Oil Shots to Evaluate Reduction in Hair Fall in Healthy Adult Human Subjects with Hair Fall
Brillare Science Private Limited0 sites16 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Health Condition 1: L659- Nonscarring hair loss, unspecified
- Sponsor
- Brillare Science Private Limited
- Enrollment
- 16
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) Age: 18 to 65 years (both inclusive) at the time of consent.
- •2\)Sex:Ã? Healthy males and non\-pregnant/non\-lactating females.
- •3\)Females of childbearing potential must have a self\-reported negative pregnancy test.
- •4\)Subjects are generally in good health.
- •5\)Females with 40\-50 counts and males with 25\-30 counts of hair fall from the hair combing method (60\-sec hair count) at the screening visit 1 before product application.
- •6\) Subjects have unwashed and untreated scalp for 5 days.
- •7\)Ã? All hair colours except grey hair.
- •8\)Ã? The subject who does head massage.
- •9\)Subjects with self\-proclaimed nonpathological thinning of hair. Ã?Â
- •10\)Subjects willing to give written informed consent and willing to follow study procedure.
Exclusion Criteria
- •1\)Subjects with a history of severe hair fall due to any clinically significant problems/s like anaemia, thyroid problems, etc.
- •2\)Ã? History of any dermatological condition of the scalp other than hair loss and/or dandruff.
- •3\)Ã? History of prior use of scalp hair growth treatment within 3 months.
- •4\)Ã? History of any prior hair growth procedures (e.g., hair transplant or laser).
- •5\)Ã? Subjects who have applied topical treatment for hair loss for at least 4 weeks and any systemic treatment for at least 3 months, before they participated in the study.
- •6\) History of alcohol or drug addiction.
- •7\)Ã? Subjects using other marketed hair fall control and/or hair growth products during the study period.
- •8\)Ã? Subjects who have plans of shaving of scalp hair during the study.
- •9\)Ã? Subjects who are on chronic oral steroids 03 months before initial application and during the study period.
- •10\)Ã? History or present condition of irritated or visibly inflamed scalp or severe scalp disease.
Outcomes
Primary Outcomes
Not specified
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