None listed
Conditions
Interventions
Intervention1: Soybean milk culture filtrate.: route of application- topical
approximately 15 weeks i.e., 105 days for each volunteer, twice application daily 9in morning and evening on scalp.
Contro
Sponsors
Ichimaru Pharcos Co Ltd
Eligibility
Inclusion criteria
Inclusion criteria: •Male and Female subjects in general good health. •Subjects in the age group 20-65 years. •Subjects willing to give a written informed consent and agree to come for a regular follow up visit. •Subjects willing to abide by and comply with the study protocol. •Subjects who have not participated in a similar investigation in the past four weeks. •Female Subjects falling under class 2 - class 5 of hair loss severity grade (evaluated as per standard photonumeric 6 point scale) •Male subjects falling under type 3 vertex â?? type 5 of hair loss severity grade (evaluated as per Norwood scale) •Subjects who agree to have hair wash everyday •Subjects who are not on crash dieting •Subjects who are willing to refrain from using hair dyes/henna at the time of screening and throughout the study. •Subjects willing not to tie hair tightly. •Subjects willing to refrain from any type of hair treatment like head massage, oil application (on scalp), perming, etc. during the study duration.
Exclusion criteria
Exclusion criteria: •Subjects who are undergoing hair growth treatment 3 months before screening into the study •Subjects who have disorders like eczema, scalp infection, etc at the time of screening. •Subjects who have alopecia areata of scalp hair. •Subjects who have undergone hair straightening using hot iron or chemicals within 3 months. •Subjects who have treatments of actinotherapy or cancer chemotherapy within 6 months before starting study or have a plan to do treatments of them during study terms. •Subjects who have history of alcoholism and/ or psychiatric disorder •Subjects who use hairpiece during study terms •Subjects who have had hair transplant •Subjects who take pharmaceutical product which cause hirsutism or sparsed fur (ex. phenytoin) •A known history or present condition of allergic response/hypersensitivity to any cosmetic ingredients and pharmaceutical products. •Subjects on oral medications (e.g. steroids, anti-oxidant) which will compromise the study. •Subjects who are on oral multivitamin tablets containing biotin, zinc, selenium and unwilling to stop the usage 1 month before enrollment into study and through out the study duration. •Subjects who are pregnant or become pregnant during study terms, lactating or nursing as established with medical history •Chronic illness which may influence the cutaneous state. •Subjects participating in other similar cosmetic or therapeutic trial. •Any underlying uncontrolled medical illness including diabetes mellitus, hypertension, HIV, hepatitis, anemia, serious disorder of heart and respiratory apparatus or any other serious medical illness.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| â?¢To evaluate the efficacy of Soybean milk culture filtrate in anti hair fall and hair regrowth in comparison to baselineTimepoint: 15 weeks for each subject, Evaluations performed on Day 3,14,56,59,84,87 | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢To evaluate the safety of Soybean milk culture filtrate in the study. â?¢To evaluate the overall improvement in hair condition.Timepoint: 15 weeks for each subject, Evaluations performed on Day 3,14,56,59,84,87 | — |
Countries
India
Contacts
Public ContactDr Mukesh Ramnane
MS Clinical Research Pvt,Ltd
Outcome results
None listed