CTRI/2013/03/003476CompletedPhase 2
A Prospective phase II Open label, monocentric,single arm study to evaluate the safety and efficacy of soybean milk culture Filtrate for anti hair fall and hair regrowth in healthy Indian human volunteers.
Ichimaru Pharcos Co Ltd1 site in 1 country40 target enrollmentStarted: February 26, 2013Last updated:
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Ichimaru Pharcos Co Ltd
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- •To evaluate the efficacy of Soybean milk culture filtrate in anti hair fall and hair regrowth in comparison to baseline
Study Overview
Brief Summary
| Study Objectives: To evaluate the efficacy of Soybean milk culture filtrate in anti hair fall and hair regrowth in comparison to baseline. To evaluate the safety of Soybean milk culture filtrate in the studyTo evaluate the overall improvement in hair condition. Study Population: 40 Subjects (Male :Female) 1:1 ratio.Study Duration:105 day’s(approximately 15 weeks),for each subject which includes 09 visits.visit schedule: 1st visit will be a screening visit during which the sensitivity test (48 hours closed patch test) for the test product will be performed. The 48 hour closed patch will be evaluated for skin irritation on visit 2(2 days from patch application). This will be followed by a 2 week wash-in period. The eligible subjects will be enrolled on Visit 3(Day 1). Visit 5(Day 14) will be a compliance visit. Visit 3,6,8 will be followed by Visit 4,7,9 on the third successive day of visit 3, visit 6 and visit 8 respectively. Phototrichogram imaging (all parameters)Will be done on visit 4,7 and 9. Phototrichogram imaging for hair growth will be done on visit 3,4,6,7,8 and 9.Imaging Nikon D60 will be done on visit 3,6 and 8. Dermatological assessment for safety and site appilication reaction will be carried out in all visits. |
Study Design
- Study Type
- Interventional
- Allocation
- Not Applicable
- Masking
- Open Label
Eligibility Criteria
- Ages
- 20.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •â€¢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
- •class 5 of hair loss severity grade (evaluated as per standard photonumeric 6 point scale) •Male subjects falling under type 3 vertex – 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
- •â€¢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.
- •â€¢Subjects who have alopecia areata of scalp hair.
- •â€¢Subjects who have undergone hair straightening using hot iron or chemicals within 3 months.
- •â€¢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.
- •â€¢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.
- •â€¢Subjects on oral medications (e.g. steroids, anti-oxidant) which will compromise the study.
- •â€¢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.
- •â€¢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.
- •â€¢Subjects participating in other similar cosmetic or therapeutic trial.
- •â€¢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.
Outcomes
Primary Outcomes
•To evaluate the efficacy of Soybean milk culture filtrate in anti hair fall and hair regrowth in comparison to baseline
Time Frame: 15 weeks for each subject, Evaluations performed on Day 3,14,56,59,84,87
Secondary Outcomes
- •To evaluate the safety of Soybean milk culture filtrate in the study.(•To evaluate the overall improvement in hair condition.)
Investigators
Study Sites (1)
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