A Proof-Of-Concept, Safety and Efficacy Study of Hair Fall Control Shampoo in Healthy Adult Human Subjects with Hair Fall Complaints

Vasu Healthcare Private Limited Vasu Research Centre0 sites32 target enrollmentTBD

Overview

No summary available.

Registry

who.int

Start Date

TBD

End Date

September 24, 2022

Last Updated

3 years ago

Study Type

Interventional

Sponsor

Vasu Healthcare Private Limited Vasu Research Centre

•1\) Age: 18 to 45 years (both inclusive) at the time of consent.
•2\) Sex:Â 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 50\-60 counts and males with 30\-40 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\) All hair colours except grey hair.
•8\) Subjects with self\-proclaimed nonpathological thinning of hair. Â
•9\)Â Subjects are willing to give written informed consent and are willing to follow the study procedure.
•10\)Subjects who have used other marketed products for hair fall control in past.

•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.