Evaluation of efficacy and safety of Hair Care Serum for Hair Fall Control and Hair Growth Potential: A prospective, open-label, single arm, single center, interventional study - VMPL-HCS-HF

Vaishnavi Microbial Private Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年3月6日

试验速览

暂无简介。

•1.Male and female subjects.
•2.Subjects in the age group 18-60 years (both the ages inclusive).
•3.Subjects suffering from excessive hair fall and/or dandruff as diagnosed by treating investigator.
•4.Hair density of >100 and <200 hair follicle per square cm as per TrichoScan measurement.
•5.Subjects falling under Grade 3 â?? 6 (Hamilton â?? Norwood Scale for Males) and Grade 1 â?? 3 (Ludwig Scale for Females) of hair loss severity.
•6.Subjects on oral medications such as vitamin supplements, including multi-vitamins can also be included.
•7.Subjects undergoing relevant treatment for Anemia (for hemoglobin correction) since the last two months can also be included.
•8.Subjects undergoing relevant treatment for thyroid conditions since their initial diagnosis can also be included.
•9.Subjects who have not participated in a similar investigation in the past three months.
•10.Subjects willing to refrain from any type of hair treatment like perming, straightening etc. during the study duration can be included.
•11.Subjects willing to give a written informed consent and agree to come for a regular follow up visit.

•1.Female Subjects who are known to be pregnant or breast feeding.
•2.Subjects who are undergoing hair growth treatment within 3 months before screening into the study.
•3.Subjects having any active scalp disease other than dandruff which may interfere in the study.
•4.Subjects during screening visit diagnosed with Hemoglobin levels <10 gm/dl in females and <12 gm/dl in males to be excluded
•5.Subjects during screening visit diagnosed with Thyroid disease to be excluded
•6.Subjects who have treatments of cancer chemotherapy last 6 months before starting study or have a plan to do treatments of them during study terms.
•7.Subjects who have history of trichotillomania.
•8.Subjects who have had hair transplant.
•9.Subjects who take pharmaceutical product which cause hirsutism.
•10.A known history or present condition of allergic response/hypersensitivity to any cosmetic ingredients and pharmaceutical products.
•11.Subjects on oral medications which will compromise the study.
•12.Chronic illness which may influence the cutaneous state.
•13.Any history of underlying uncontrolled medical illness including diabetes mellitus, hypertension, HIV, hepatitis, serious disorder of heart and respiratory apparatus or any other serious medical illness as established through medical history or diagnostic tests.
•14.Subjects who could not be relied upon to comply with the study procedures.

发起方

Vaishnavi Microbial Private Limited