A Clinical Study to Assess the Safety and Effectiveness of Plant Based Biotin in Healthy Human Subjects With Thin, Dry, and Brittle Hair
Hair Thinning, Hair Brittle, Dry Hair
About this trial
This is an interventional supportive care trial for Hair Thinning
Eligibility Criteria
Inclusion Criteria: Age: 30 to 55 years (both inclusive) at the time of consent. Sex: Healthy males and non-pregnant/non-lactating females. Females of childbearing potential must have a self-reported negative pregnancy test. Subjects are generally in good health. Subject with self-proclaimed nonpathological thin, dry and brittle hair. Subject with normal Fitzpatrick skin type III to VI (Human skin colour determination scale). Subject has a score of at least "mild skin aging" based on PGA at screening visit. Subject with Glogau Skin Age II or III as assessed by the Dermatologist/ Dermatologist Trained Evaluator. Subject is willing to forgo cosmetic procedures 3 months prior to and for the duration of the study. Subject is able to remain on stable doses of contraceptive or replacement hormonal therapy, including no therapy, 6 weeks prior to and for the duration of the study. Subject is able to follow their normal skin care routines and to refrain from introducing any new skin care products during the study. Subject is able to forgo changes in baseline medications and nutritional supplements during the study period. If the subject is of childbearing potential, is practicing and agrees to maintain an established method of birth control (IUD, hormonal implant device/injection, regular use of birth control pills or patch, diaphragm, condoms with spermicide or sponge with spermicidal jelly, cream or foam, partner vasectomy or abstinence). Females will be considered as non-childbearing potential if they are surgically sterile, have been post- menopausal for at least 1 year or have had a tubal ligation. If currently using hormonal contraception, has been using this form of contraception for at least 6 months and agrees to continue using the same contraception for the duration of the study. Subjects are willing not to introduce any new soaps, cleansers, laundry detergents, lotions, creams, shampoos etc. for the duration of the study. Subjects are willing to give written informed consent and are willing to follow the study procedure. Subjects who have used other marketed products for hair thinning in the past. Subjects who commit not to use medicated/ prescription shampoos/hair care products (containing Minoxidil / Anti-thinning agents) or any other hair growth, treatment for thin hair, or hair products other than the test product for the entire duration of the study. Willing to use test product throughout the study period Exclusion Criteria: Subjects with a history of hair thinning/hair fall due to any clinically significant problems/s like anaemia, thyroid problems, etc. Subject has a history of allergy or sensitivity to the test treatment ingredients like sesbania agati and others etc. Subject has a history of any dermatological condition of the scalp other than hair loss and/or dandruff or active dermatological condition that might interfere with the clinical assessments (e.g. tattoos, eczema, psoriasis, acne, etc.). Subject has used any systemic therapy with chronic antibiotic therapy, retinoids, and/or oral steroids during the 4 weeks prior to the start or anticipates having to use at any point during the study. Subject has applied any topical retinoids within 2 weeks of the screening visit or anticipates having to use at any point during the study. Subject is not willing to avoid unprotected sun or other UV radiation exposure during the study period. Subject is currently pregnant/breastfeeding. Subject has a history of prior use of hair growth treatment within 3 months. Subject has a history of any prior hair growth procedures (e.g., hair transplant or laser). Subject has a history of alcohol or drug addiction. Subjects who have plans of shaving scalp hair during the study. Subject has a past or present condition of irritated or visibly inflamed scalp or severe scalp disease. Subject who is currently participating in or planning on starting weight loss program that may result in a significant change in overall body weight. Any other condition which could warrant exclusion from the study, as per the dermatologist's/investigator's discretion. Pregnant or breastfeeding or planning to become pregnant during the study period. History of chronic illness which may influence the cutaneous state. Subjects participating in other similar cosmetics, devices or therapeutic trials or hair/scalp/skin care products within the last four weeks.
Sites / Locations
- NovoBliss Research Pvt Ltd
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
SesZen-Bio™
Placebo (Tapioca based starch Capsules)
SesZen-Bio™ is specially formulated for healthy hairs and healthy skin. Fortified with Sesbania Agati for 2X Hair Follicle Stimulation & Hair Fall Control, to Promote Shiny Hair, biotin that Supports Hair Growth.
tapioca starch, is a starchy white flour that has a slight sweet flavor to it and is prepared by extrusion and coating process.