Skip to main content
OpenTrials
Completed

NCT Number: NCT06551818

A Clinical Study to Assess Safety, Efficacy and In-use Tolerability of Different Dosages of Hair Growth Products in Patients With Mild to Moderate Androgenic Alopecia (Grade I to III).

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).

Completed

Looking for future studies?

Notify Me

Key information

Age range

25 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NovoBliss Research Pvt Ltd

Ahmedabad, Gujarat, 382481, India

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Patients having mild to moderate Androgenic Alopecia (Grade I to III) during clinical study and grade will be evaluated by the dermatologist by using Norwood-Hamilton classification and Ludwig pattern scale for female.
  • Female with 40-50 counts and male with 25 -30 counts of hair fall at screening.
  • Patient 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.
  • If the patient 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.
  • Patients are willing to give written informed consent and are willing to follow the study procedure.
  • Patients who commit not to use any other medicated/ prescription shampoos/hair care products (containing Minoxidil), any other hair growth products or hair colour or dye, other than the test products for the entire duration of the study.
  • Willing to consume test products throughout the study period.
  • Patient is willing and able to follow and allow study staff to performed study test methods.
  • Patient is willing and able to follow the study directions, to participate in the study, returning for all specified visits.
  • Patient must be able to understand and provide written informed consent to participate in the study.

Exclusion criteria

  • 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.
  • Patient who had taken any systemic treatment for at least 3 months.
  • History of alcohol or drug addiction.
  • Patient having history or resent condition of irritated or visibly inflamed scalp or severe scalp disease.
  • Patient who is currently participating in or planning on starting weight loss program that may result in a significant change in overall body weight.
  • Pregnant or breast feeding or planning to become pregnant during the study period.
  • History of chronic illness which may influence the cutaneous state.
  • Patient have participated any clinical research study related to hair care products.
  • Patient have history of mastectomy for cancer involving removal of lymph nodes within the past year, or treatment of any type of cancer within the last 6 months.

Treatment and study plan

SesZen-Bio Low Dose 1 (350 mg extract)

Other

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

SesZen-Bio Low Dose 1 (150 mg liposomal)

Other

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

SesZen-Bio High Dose 1 (500 mg extract)

Other

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

Placebo

Other

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

Primary outcomes

  1. Change in hair thickness by using CASLite Nova (instrumental analysis)

    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

  2. Change in hair density by using CASLite Nova (instrumental analysis)

    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

  3. Change in hair growth rate by using CASLite Nova (instrumental analysis)

    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

Secondary outcomes

  1. Change in keratin measurement from hair by using CASLite Nova (instrumental analysis)

    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

  2. Change in hair length

    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)

  3. Change in A:T ratio by hair pluck test

    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.

  4. Change hair fall from root test by 60 seconds hair combing test

    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.

  5. Change in number of new hairs by using CASLite Nova (instrumental analysis)

    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

  6. Change in hair regrowth by using CASLite Nova (instrumental analysis)

    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

  7. Change in hair root strength

    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

  8. Change in general appearance of hair volume

    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

  9. Change in general appearance of hair plasticity

    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

  10. Change in general appearance of hair density

    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

  11. Change in general appearance of hair dryness

    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

  12. Change in general appearance of hair shininess

    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

  13. Change in general appearance of hair smoothness

    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

  14. Change in general appearance of hair strength

    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

  15. Change in general appearance of hair oiliness

    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

  16. Change in general appearance of scalp Itchiness

    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

  17. Change in general appearance of scalp redness

    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

  18. Change in general appearance of scalp roughness

    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

  19. Change in general appearance of scalp scaliness

    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

  20. Change in general appearance of scalp dryness

    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

  21. Change in products perception questionnaire

    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

  22. Change in tensile strength by TESTRONIX tensile tester (instrumental assessment)

    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

  23. Change in nail brittleness

    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

  24. 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- haemoglobin

  25. 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- haematocrit

  26. 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- RBC (Red Blood Corpuscle)

  27. 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- MCH (mean corpuscular hemoglobin)

  28. 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- MCV (mean corpuscular volume)

  29. 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- MCHC (mean corpuscular haemoglobin concentration)

  30. 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 CBC- WBC (White Blood Cell)

  31. 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- SGOT (serum glutamic oxaloacetic transaminase)

  32. 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- SGPT (serum glutamic oxaloacetic transaminase)

  33. 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- serum creatinine

  34. 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- BUN (blood urea nitrogen)

  35. 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- RBS (random blood sugar)

  36. 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- PPBS (post-prandial blood sugar)

  37. 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- TC (Total cholesterol )

  38. 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- TG (Triglyceride levels)

  39. 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- HDL (high-density lipoproteins)

  40. 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- LDL (low-density lipoproteins)

  41. 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- uric acid

  42. 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 Biochemistry- VLDL (very low-density lipoprotein)

  43. 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 testosterone

  44. 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 free testosterone

  45. Change in dihydrotestosterone

    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

  46. 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 in CRP (C-reactive protein)

  47. Change in random cortisol

    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

  48. 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 ferritin

  49. 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-albumin

  50. 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-blood

  51. 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-glucose

  52. 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-pH

  53. 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-colour

  54. 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-appearance

  55. Change in urinalysis-deposits

    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

Sponsors and collaborators

Lead sponsor

NovoBliss Research Pvt Ltd

Other

Collaborators

  • Zywie Ventures Privated Ltd

Registry information

Official study title

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).

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 13, 2024
Registry last updated
Jul 31, 2026

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.

Published trials that share one or more normalized conditions with this study.