This is a prospective, interventional, exploratory, four-arm - dose response study, comparative, double-blind, randomized, placebo-control, proof of concept, safety, efficacy and in-use tolerability study of three different dosage formulation of test hair growth products and placebo in patients with mild to moderate Androgenic Alopecia (Grade I to III).
Age: 25 to 45 years and above (both inclusive) at the time of consent.
Sex: Males and non-pregnant/non-lactating females (preferably equal number of males and females).
Females of childbearing potential must have a self-reported negative urine pregnancy.
Patient is in good general health as determined by the Investigator on the basis of medical history.
Patient have history of severe hair fall due to any clinically significant problems like anaemia, thyroid problems.
Patient have history of any dermatological condition of the scalp other than hair loss and dandruff.
Patient have history of any prior hair growth procedures (e.g. hair transplant or laser).
Patient who had taken topical treatment of hair loss for at least 4 weeks.
Parallel
SesZen-Bio Low Dose 1 (350 mg extract)
Other interventionMode of Usage: Swallow the capsule whole with a full glass of water without chewing, crushing, or opening it. Dosage form: Capsule Frequency: One time daily after meal Rout of administration: Oral
SesZen-Bio Low Dose 1 (150 mg liposomal)
Other interventionMode of Usage: Swallow the capsule whole with a full glass of water without chewing, crushing, or opening it. Dosage form: Capsule Frequency: One time daily after meal Rout of administration: Oral
SesZen-Bio High Dose 1 (500 mg extract)
Other interventionMode of Usage: Swallow the capsule whole with a full glass of water without chewing, crushing, or opening it. Dosage form: Capsule Frequency: One time daily after meal Rout of administration: Oral
Placebo
Other interventionMode of Usage: Swallow the capsule whole with a full glass of water without chewing, crushing, or opening it. Dosage form: Capsule Frequency: One time daily after meal Rout of administration: Oral
Change in hair thickness by using CASLite Nova (instrumental analysis)
To assess the effectiveness of the test products in terms of change in hair thickness
Change in hair density by using CASLite Nova (instrumental analysis)
To assess the effectiveness of the test products in terms of change in hair density
Change in hair growth rate by using CASLite Nova (instrumental analysis)
To assess the effectiveness of the test products in terms of change in hair growth rate
Change in keratin measurement from hair by using CASLite Nova (instrumental analysis)
To assess the effectiveness of the test products in terms of change in keratin from Androgenic Alopecia affected targeted area and normal scalp- tattoo area measurement from hair
Change in hair length
To assess the effectiveness of the test products in terms of change in hair length (AG affected area and standard area) by using CASLite Nova (instrumental analysis) followed by Image pro-analysis (software analysis)
Change in A:T ratio by hair pluck test
To assess the effectiveness of the test products in terms of change in A:T ratio by dermatologist.
Change hair fall from root test by 60 seconds hair combing test
To assess the effectiveness of the test products in terms of change hair fall by dermatologist.
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NovoBliss Research Pvt Ltd
Lead sponsor
Zywie Ventures Privated Ltd
Collaborator
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