CTRI/2018/01/011118
Completed
Phase 3
A single-blinded, randomized clinical study to evaluate and compare the safety and efficacy of a test hair leave-on product (Hair Tonic) with a comparator product for scalp hair growth and density in healthy male and female subjects
ITC Life Sciences Technology Centre0 sites100 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- ITC Life Sciences Technology Centre
- Enrollment
- 100
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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