A study to assess the safety and efficacy of Hair tonics for hair growth and density in men and women.
- Registration Number
- CTRI/2018/01/011118
- Lead Sponsor
- ITC Life Sciences Technology Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
1Subjects to be 21 to 55 year old and generally in good health
2Female subjects falling under grade 2, 3 and grade 4 of hair loss severity index as per Ludwig Photo numeric scale.
3Male subjects falling under grade 2, 3 and grade 4 of hair loss severity index as per modified Norwood scale.
4Subject having hair density of 100-200 /cm2.
5Subjects with > 15 strands of fallen hair as assessed by comb test
6Subjects willing to participate in the study voluntarily and agreeing to give their consent for their participation in the study in a signed document.
7Subjects agreeing to maintain the same hairstyle, hair length and hair color throughout the study
8Subjects consenting to have a dot tattoo or markings placed in the target area of the scalp during the study
9Subjects Willing to maintain the habits and products during the study
10Subjects consenting to comply with the study requirements for 6 consecutive months
11Subjects willing to refrain from other AGA/Female pattern hair loss treatments during the entire study duration
12Subjects with no clinically significant disease or abnormal laboratory results taken at the screening visit
13Subjects agreeing to abstain from using any hair growth affecting oral or topical medication including over the counter and herbal medications, finasteride or dutasteride during the course of this study
14Subjects who are not on crash dieting
1Subjects who have undergone hair growth treatment 3 months before screening into the study under discussion.
2Subjects having scalp conditions such as folliculitis, seborrheoic psoriasis of scalp, seborrheoic dermatitis and lichen planopilaris at the time of screening.
3Subjects with alopecia areata of scalp hair and scarring alopecia due to any cause such as DLE, SLE and Lichen planus.
4Subjects who have undergone hair straightening using hot iron or chemicals within 3 months prior to the screening.
5Subjects who have undergone treatments of cancer chemotherapy within 6 months before starting study or plan to undergo the same during study course.
6Subjects with a history of alcoholism and/ or psychiatric disorder including trichotillomania.
7Subjects who have had hair transplantation treatment.
8Subjects who take pharmaceutical products that may cause hirsutism (ex. phenytoin) and finesteride for androgenic alopecia.
9Subjects with a known history or present condition of allergic response/hypersensitivity to any cosmetic ingredients and pharmaceutical products.
10Subjects on oral medications (e.g. steroids, anti-oxidant) which will compromise the study.
11Subjects who are on oral multivitamin tablets containing biotin, zinc, selenium and unwilling to stop the usage 1 month before enrollment into study and throughout the study duration.
12Subjects with hypertension and thyroid as confirmed by history or blood screening.
13Female subjects who have been pregnant in last 1 year or lactating or nursing as established by medical history or planning to become pregnant during the study period.
14Female subjects with the complaint of post pregnancy hair fall.
15Subjects who have undergone hair dyeing in last 1 month or plan to undergo the same during the study period.
16Subjects with a history of acute severe illness in past 3 months as established by the medical history.
17Subjects suffering from any form of chronic illness which may influence the cutaneous state.
18Subjects participating in other similar cosmetic or therapeutic trial.
19Any underlying uncontrolled medical illness including diabetes mellitus, HIV, hepatitis, anemia, serious disorder of heart and respiratory apparatus or any other serious medical illness.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method �To evaluate the efficacy of the investigational product for scalp hair growth, density, Anagen:Telogen ratio and reduction in hair fall in comparison to the baseline and the respective comparator product in male & female subjectsTimepoint: Day -15,Day 0,Day 2,Day 30,Day 32,Day 60,Day 62,Day 90,Day 92,Day 120,Day 122,Day 150,Day 152,Day 180 and Day 182
- Secondary Outcome Measures
Name Time Method �To evaluate the safety and overall changes in scalp and hair condition on application of the investigational product in comparison with the baseline and the respective comparator product in male & female subjects.Timepoint: Day -15,Day 0,Day 30,Day 60,Day 90,Day 120,Day 150,and Day 180