CTRI/2022/11/047330
Completed
未知
A Proof-Of-Concept, Safety and Efficacy Study of Hair Growth Promoting Product in Healthy Adult Human Subjects with Hair Fall Complaints
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Anveya Living Private Limited
- Enrollment
- 29
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\)Age: 18 to 45 years (both inclusive) at the time of consent.
- •2\)Sex: 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 test product usage.
- •6\)Subject has hair length long enough to pluck the hairs.
- •7\)Subjects have unwashed and untreated scalp for 5 days.
- •8\)All hair colours except grey hair.
- •9\)Subjects with self\-proclaimed nonpathological thinning of hair.
- •10\)Subjects are willing to give written informed consent and are willing to follow the 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\)History of any dermatological condition of the scalp other than hair loss and/or dandruff.
- •3\)History of prior use of hair fall control \| hair growth treatment within 3 months.
- •4\)History of any prior hair growth procedures (e.g., hair transplant or laser).
- •5\)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\)Subjects using other marketed hair fall control and/or hair growth products during the study period.
- •8\)Subjects who have plans of shaving scalp hair during the study.
- •9\)Subjects who are on chronic oral steroids 03 months before initial application and during the study period.
- •10\)History or present condition of irritated or visibly inflamed scalp or severe scalp disease.
Outcomes
Primary Outcomes
Not specified
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