NovoBliss Research Pvt Ltd
Ahmedabad, Gujarat, 382481, India
NCT Number: NCT06551818
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).
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Notify Me25 year–45 year
All sexes
Interventional
Not applicable
Ahmedabad, Gujarat, 382481, India
A total of up to 72 patients (18 patients/arm) preferably equal number of male and female will be enrolled to ensure a total of 60 patients (15 patients/ arm) to complete the study.
There will be total of 8 visits during the study. The duration of the study will be 180 days (6 months) from the enrolment.
Visit 01 (Day -04): Screening, Tattoo creation, hair growth measurement. Visit 02(Day 01):Enrolment, hair growth rate measurement, hair length (androgenic affected targeted area and standard area), hair thickness, hair density, scalp condition for keratin measurement, A: T ratio, number of new hairs, number of hair fall from root, hair root strength, general appearance of hair, general appearance of scalp, earlier product perception questionnaire, global pictures of head crown, CBC, Biochemical tests, free testosterone, testosterone, dihydrotestosterone, CRP, Cortisol random, ferritin, urinalysis.
Visit 03 (Day 45): Hair Length (Androgenic Alopecia affected targeted area standard area), hair thickness, hair density, scalp condition for keratin measurement, hair regrowth (AG affected area), number of hair fall from root, number of new hairs (full scalp and normal scalp- tattoo area), hair root strength, general appearance of hair, general appearance of scalp, product perception questionnaire, global pictures of head crown.
Visit 04 (Day 87): Tattoo creation, hair growth measurement Visit 05 (Day 90):Hair growth rate measurement, hair length (Androgenic Alopecia affected targeted area and standard area), hair thickness, hair density, scalp condition for keratin measurement, A: T ratio, hair regrowth (AG affected area), number of new hairs (on full scalp, normal scalp- tattoo area), number of hair fall from root, hair root strength, general appearance of hair, general appearance of scalp, product perception questionnaire, digital photographs of global pictures head crown.
Visit 06 (Day 135):Hair length (Androgenic Alopecia affected targeted area and standard area), hair thickness, hair density, scalp condition for keratin measurement, hair regrowth (AG affected area), number of hair fall from root, number of new hair (on full scalp, normal scalp- tattoo area), hair root strength from root, general appearance of hair, general appearance of scalp, product perception questionnaire, digital photographs of global pictures head crown.
Visit 07 (Day 177): Tattoo creation, hair growth measurement Visit 08 (Day 180): Hair growth rate measurement, hair length (standard area and Androgenic Alopecia affected targeted area), hair thickness, hair density, scalp condition for keratin measurement, A: T Ratio, number of new hair (on full scalp, AG affected area), hair regrowth (AG affected area), number of hair fall from root, hair root strength, general appearance of hair, general appearance of scalp, product perception questionnaire, global pictures of head crown CBC, Biochemical tests, free testosterone, testosterone, dihydrotestosterone, CRP, Cortisol random, ferritin, urinalysis.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Mode 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
Mode 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
Mode 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
Mode 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
Time frame: Baseline before usage of the test products on Day 01 and after usage of the test products on Day 45, Day 90, Day 135 and on Day 180
To assess the effectiveness of the test products in terms of change in hair thickness
Time frame: Baseline before usage of the test products on Day 01 and after usage of the test products on Day 45, Day 90, Day 135 and on Day 180
To assess the effectiveness of the test products in terms of change in hair density
Time frame: 04 before Day 01, Day 01, Day 87, Day 90, Day 177 and on Day 180
To assess the effectiveness of the test products in terms of change in hair growth rate
Time frame: Baseline before usage of the test products on Day 01 and after usage of the test products on Day 45, Day 90, Day 135 and on Day 180
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
Time frame: Baseline before usage of the test products on Day 01 and after usage of the test products on Day 45, Day 90, Day 135 and on Day 180
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)
Time frame: Baseline before usage of the test products on Day 01 and after usage of the test products on Day 90 and on Day 180
To assess the effectiveness of the test products in terms of change in A:T ratio by dermatologist.
Time frame: 04 before Day 01, Day 01, Day 87, Day 90, Day 177 and on Day 180
To assess the effectiveness of the test products in terms of change hair fall by dermatologist.
Time frame: Baseline before usage of the test products on Day 01 and after usage of the test products on Day 45, Day 90, Day 135 and on Day 180
To assess the effectiveness of the test products in terms of change in number of new hairs
Time frame: Baseline before usage of the test products on Day 01 and after usage of the test products on Day 45, Day 90, Day 135 and on Day 180
To assess the effectiveness of the test products in terms of change in hair regrowth from Androgenic Alopecia affected targeted area
Time frame: Baseline before usage of the test products on Day 01 and after usage of the test products on Day 45, Day 90, Day 135 and on Day 180
To assess the effectiveness of the test products in terms of change in hair root strength by dermatological assessment
Time frame: baseline before usage of the test products on Day 01 and after usage of the test products on Day 45, Day 90 and on Day 180
To assess the effectiveness of the test products in terms of change in general appearance of hair volume in which score done as 1= small 3=full
Time frame: baseline before usage of the test products on Day 01 and after usage of the test products on Day 45, Day 90 and on Day 180
To assess the effectiveness of the test products in terms of change in general appearance of hair plasticity in which score done as 1=waved and 3=average
Time frame: baseline before usage of the test products on Day 01 and after usage of the test products on Day 45, Day 90 and on Day 180
To assess the effectiveness of the test products in terms of change in general appearance of hair density in which score as 1=thinned and 2=dense
Time frame: baseline before usage of the test products on Day 01 and after usage of the test products on Day 45, Day 90 and on Day 180
To assess the effectiveness of the test products in terms of change in general appearance of hair dryness in which score done as 1=none, and 4=excessive
Time frame: baseline before usage of the test products on Day 01 and after usage of the test products on Day 45, Day 90 and on Day 180
To assess the effectiveness of the test products in terms of change in general appearance of hair shininess in which score done as 1=poor and 3=good
Time frame: baseline before usage of the test products on Day 01 and after usage of the test products on Day 45, Day 90 and on Day 180
To assess the effectiveness of the test products in terms of change in general appearance of hair smoothness in which score done as 1=poor, and 3=good
Time frame: baseline before usage of the test products on Day 01 and after usage of the test products on Day 45, Day 90 and on Day 180
To assess the effectiveness of the test products in terms of change in general appearance of hair strength in which score done as 1=poor, and 3=good
Time frame: baseline before usage of the test products on Day 01 and after usage of the test products on Day 45, Day 90 and on Day 180
To assess the effectiveness of the test products in terms of change in general appearance of hair oiliness in which score done as 1=none and 4=excessive
Time frame: baseline before usage of the test products on Day 01 and after usage of the test products on Day 45, Day 90 and on Day 180
To assess the effectiveness of the test products in terms of change in general appearance of scalp Itchiness in which score done as 1= none, and 4=excessive
Time frame: baseline before usage of the test products on Day 01 and after usage of the test products on Day 45, Day 90 and on Day 180
To assess the effectiveness of the test products in terms of change in general appearance of scalp redness in which score done as 1= none, and 4=excessive
Time frame: baseline before usage of the test products on Day 01 and after usage of the test products on Day 45, Day 90 and on Day 180
To assess the effectiveness of the test products in terms of change in general appearance of scalp roughness in which score done as 1= none, and 4=excessive
Time frame: baseline before usage of the test products on Day 01 and after usage of the test products on Day 45, Day 90 and on Day 180
To assess the effectiveness of the test products in terms of change in general appearance of scalp scaliness in which score done as 1=none, and 4=excessive
Time frame: baseline before usage of the test products on Day 01 and after usage of the test products on Day 45, Day 90 and on Day 180
To assess the effectiveness of the test products in terms of change in general appearance of scalp dryness in which score done as none, mild, moderate and excessive
Time frame: Before usage of the test products on Day 01 and after usage of the test products on Day 45, Day 90, Day 135 and on Day 180
To evaluate the effectiveness of the test products in terms of change in products perception questionnaire by using 5-point Likert scale in which 1= not at all and 5= to large extent
Time frame: Baseline before usage of test product on Day 01 and after usage of test product on Day 180.
To assess the effectiveness of the test products in terms of change in tensile strength of hairs
Time frame: Baseline before usage of test product on Day 01 and after usage of test products and on Day 180
To evaluate the effect of test products in terms of change in nail brittleness in which score done by 5 liert scale in which 1-not at all and 5- to large extent
Time frame: Baseline before usage of test products on Day 01 and after usage of test products on Day 180
To evaluate the effect of test products in terms of change in CBC- haemoglobin
Time frame: Baseline before usage of test products on Day 01 and after usage of test products on Day 180
To evaluate the effect of test products in terms of change in CBC- haematocrit
Time frame: Baseline before usage of test products on Day 01 and after usage of test products on Day 180
To evaluate the effect of test products in terms of change in CBC- RBC (Red Blood Corpuscle)
Time frame: Baseline before usage of test products on Day 01 and after usage of test products on Day 180
To evaluate the effect of test products in terms of change in CBC- MCH (mean corpuscular hemoglobin)
Time frame: Baseline before usage of test products on Day 01 and after usage of test products on Day 180
To evaluate the effect of test products in terms of change in CBC- MCV (mean corpuscular volume)
Time frame: Baseline before usage of test products on Day 01 and after usage of test products on Day 180
To evaluate the effect of test products in terms of change in CBC- MCHC (mean corpuscular haemoglobin concentration)
Time frame: Baseline before usage of test products on Day 01 and after usage of test products on Day 180
To evaluate the effect of test products in terms of change in CBC- WBC (White Blood Cell)
Time frame: Baseline before usage of test products on Day 01 and after usage of test products on Day 180
To evaluate the effect of test products in terms of change in Biochemistry- SGOT (serum glutamic oxaloacetic transaminase)
Time frame: Baseline before usage of test products on Day 01 and after usage of test products on Day 180
To evaluate the effect of test products in terms of change in Biochemistry- SGPT (serum glutamic oxaloacetic transaminase)
Time frame: Baseline before usage of test products on Day 01 and after usage of test products on Day 180
To evaluate the effect of test products in terms of change in Biochemistry- serum creatinine
Time frame: Baseline before usage of test products on Day 01 and after usage of test products on Day 180
To evaluate the effect of test products in terms of change in Biochemistry- BUN (blood urea nitrogen)
Time frame: Baseline before usage of test products on Day 01 and after usage of test products on Day 180
To evaluate the effect of test products in terms of change in Biochemistry- RBS (random blood sugar)
Time frame: Baseline before usage of test products on Day 01 and after usage of test products on Day 180
To evaluate the effect of test products in terms of change in Biochemistry- PPBS (post-prandial blood sugar)
Time frame: Baseline before usage of test products on Day 01 and after usage of test products on Day 180
To evaluate the effect of test products in terms of change in Biochemistry- TC (Total cholesterol )
Time frame: Baseline before usage of test products on Day 01 and after usage of test products on Day 180
To evaluate the effect of test products in terms of change in Biochemistry- TG (Triglyceride levels)
Time frame: Baseline before usage of test products on Day 01 and after usage of test products on Day 180
To evaluate the effect of test products in terms of change in Biochemistry- HDL (high-density lipoproteins)
Time frame: Baseline before usage of test products on Day 01 and after usage of test products on Day 180
To evaluate the effect of test products in terms of change in Biochemistry- LDL (low-density lipoproteins)
Time frame: Baseline before usage of test products on Day 01 and after usage of test products on Day 180
To evaluate the effect of test products in terms of change in Biochemistry- uric acid
Time frame: Baseline before usage of test products on Day 01 and after usage of test products on Day 180
To evaluate the effect of test products in terms of change in Biochemistry- VLDL (very low-density lipoprotein)
Time frame: Baseline before usage of test products on Day 01 and after usage of test products on Day 180
To evaluate the effect of test products in terms of change in testosterone
Time frame: Baseline before usage of test products on Day 01 and after usage of test products on Day 180
To evaluate the effect of test products in terms of change in free testosterone
Time frame: Baseline before usage of test products on Day 01 and after usage of test products on Day 180
To evaluate the effect of test products in terms of change in dihydrotestosterone
Time frame: Before usage of test products on Day 01 from baseline and after usage of test products on Day 180
To evaluate the effect of test products in terms of change in CRP (C-reactive protein)
Time frame: Before usage of test products on Day 01 from baseline and after usage of test products on Day 180
To evaluate the effect of test products in terms of change random cortisol
Time frame: Baseline before usage of test products on Day 01 and after usage of test products on Day 180
To evaluate the effect of test products in terms of change in ferritin
Time frame: Baseline before usage of test products on Day 01 and after usage of test products on Day 180
To evaluate the effect of test products in terms of change in urinalysis-albumin
Time frame: Baseline before usage of test products on Day 01 and after usage of test products on Day 180
To evaluate the effect of test products in terms of change in urinalysis-blood
Time frame: Baseline before usage of test products on Day 01 and after usage of test products on Day 180
To evaluate the effect of test products in terms of change in urinalysis-glucose
Time frame: Baseline before usage of test products on Day 01 and after usage of test products on Day 180
To evaluate the effect of test products in terms of change in urinalysis-pH
Time frame: Baseline before usage of test products on Day 01 and after usage of test products on Day 180
To evaluate the effect of test products in terms of change in urinalysis-colour
Time frame: Baseline before usage of test products on Day 01 and after usage of test products on Day 180
To evaluate the effect of test products in terms of change in urinalysis-appearance
Time frame: Baseline before usage of test products on Day 01 and after usage of test products on Day 180
To evaluate the effect of test products in terms of change in urinalysis-deposits
NovoBliss Research Pvt Ltd
Other
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).
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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