None listed
Conditions
Interventions
Intervention1: Hair Tonic F-06: Female Subjects ââ?¬â?? Leave On Product, about 9.0 ml once daily topical application for six months.
Intervention2: Hair Tonic X-42: Male Subjects ââ?¬â?? Leave On P
Sponsors
ITC Life Sciences Technology Centre
Eligibility
Inclusion criteria
Inclusion criteria: 1 Subjects to be 21 to 55 year old and generally in good health 2 Female subjects falling under grade 2, 3 and grade 4 of hair loss severity index as per Ludwig Photo numeric scale. 3 Male subjects falling under grade 2, 3 and grade 4 of hair loss severity index as per modified Norwood scale. 4 Subject having hair density of 100-200 /cm2. 5 Subjects with > 15 strands of fallen hair as assessed by comb test 6 Subjects willing to participate in the study voluntarily and agreeing to give their consent for their participation in the study in a signed document. 7 Subjects agreeing to maintain the same hairstyle, hair length and hair color throughout the study 8 Subjects consenting to have a dot tattoo or markings placed in the target area of the scalp during the study 9 Subjects Willing to maintain the habits and products during the study 10 Subjects consenting to comply with the study requirements for 6 consecutive months 11 Subjects willing to refrain from other AGA/Female pattern hair loss treatments during the entire study duration 12 Subjects with no clinically significant disease or abnormal laboratory results taken at the screening visit 13 Subjects 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 14 Subjects who are not on crash dieting
Exclusion criteria
Exclusion criteria: 1 Subjects who have undergone hair growth treatment 3 months before screening into the study under discussion. 2 Subjects having scalp conditions such as folliculitis, seborrheoic psoriasis of scalp, seborrheoic dermatitis and lichen planopilaris at the time of screening. 3 Subjects with alopecia areata of scalp hair and scarring alopecia due to any cause such as DLE, SLE and Lichen planus. 4 Subjects who have undergone hair straightening using hot iron or chemicals within 3 months prior to the screening. 5 Subjects who have undergone treatments of cancer chemotherapy within 6 months before starting study or plan to undergo the same during study course. 6 Subjects with a history of alcoholism and/ or psychiatric disorder including trichotillomania. 7 Subjects who have had hair transplantation treatment. 8 Subjects who take pharmaceutical products that may cause hirsutism (ex. phenytoin) and finesteride for androgenic alopecia. 9 Subjects with a known history or present condition of allergic response/hypersensitivity to any cosmetic ingredients and pharmaceutical products. 10 Subjects on oral medications (e.g. steroids, anti-oxidant) which will compromise the study. 11 Subjects 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. 12 Subjects with hypertension and thyroid as confirmed by history or blood screening. 13 Female 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. 14 Female subjects with the complaint of post pregnancy hair fall. 15 Subjects who have undergone hair dyeing in last 1 month or plan to undergo the same during the study period. 16 Subjects with a history of acute severe illness in past 3 months as established by the medical history. 17 Subjects suffering from any form of chronic illness which may influence the cutaneous state. 18 Subjects participating in other similar cosmetic or therapeutic trial. 19 Any underlying uncontrolled medical illness including diabetes mellitus, HIV, hepatitis, anemia, serious disorder of heart and respiratory apparatus or any other serious medical illness.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ââ?¬Â¢ 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
| Measure | Time frame |
|---|---|
| ââ?¬Â¢ 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 | — |
Countries
India
Contacts
Public ContactDeepak K P
Leads Clinical Research and Bio Services Pvt. Ltd
Outcome results
None listed