Clinical trial NCT06556056: An Exploratory Clinical Study to Assess Safety, Efficacy and In-Use Tolerability of Three Different Hair Growth Products in Patients With Mild to Moderate Androgenic Alopecia (Grade I to III)
Official title: Exploratory, Prospective, Three-arm, Interventional, Comparative, Randomized, Double-blind, Placebo-controlled, Safety, Efficacy and In-use Tolerability Study of Hair Growth Product(s) in Patients With Mild to Moderate Androgenic Alopecia: (Grade I to III)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Androgenic Alopecia
Lead sponsor: NovoBliss Research Pvt Ltd
Sponsor class: OTHER
Collaborators: name: Zywie Ventures Privated Ltd
First posted: 2024-08-15
Enrollment: 54
Sex: ALL
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This is an exploratory, prospective, three-arm, interventional, comparative, randomized, double-blind, placebo-controlled, safety, efficacy and in-use tolerability study of hair growth products in the patients mild to moderate androgenic alopecia (Grade I to III).

Detailed description: A total of up to 54 patients (18 patients/arm) preferably equal number of male and female will be enrolled to ensure a total of 45 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 1(Day -04): Screening, Tattoo creation, hair growth measurement. Visit 02(Day 01): Enrolment, hair growth rate measurement, hair length, 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.

Visit 03 (Day 45): Hair Length, hair thickness, hair density, scalp condition for keratin measurement, hair regrowth, number of hair fall from root, number of new hairs from the full scalp, AG affected, 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 \[Day 90 (03 days from visit 04)\]:Hair growth rate measurement, hair length, hair thickness, hair density, scalp condition for keratin measurement, A: T ratio, hair regrowth, number of new hairs, 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, hair thickness, hair density, scalp condition for keratin measurement, hair regrowth, number of hair fall from root, number of new hair, 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: \[Day 180 (03 days from Visit 07)\]: Hair growth rate measurement, hair length, hair thickness, hair density, scalp condition for keratin measurement, A: T Ratio, number of new hair, hair regrowth, 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

Eligibility criteria: Inclusion Criteria:

1. Age: 25 to 45 years and above (both inclusive) at the time of consent.
2. Sex: Males and non-pregnant/non-lactating females (preferably equal number of males and females).
3. Females of childbearing potential must have a self-reported negative urine pregnancy.
4. Subject is in good general health as determined by the Investigator on the basis of medical history.
5. 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.
6. Female with 40-50 counts and male with 25 -30 counts of hair fall at screening.
7. 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.
8. 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.
9. Patients are willing to give written informed consent and are willing to follow the study procedure.
10. 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.
11. Willing to use test products throughout the study period.
12. Subject is willing and able to follow and allow study staff to performed study test methods.
13. Subject is willing and able to follow the study directions, to participate in the study, returning for all specified visits.
14. Subject must be able to understand and provide written informed consent to participate in the study.

Exclusion Criteria:

1. Subject have history of severe hair fall due to any clinically significant problems like anaemia, thyroid problems.
2. Subject have history of any dermatological condition of the scalp other than hair loss and dandruff.
3. Subject have history of any prior hair growth procedures (e.g. hair transplant or laser).
4. Subject who had taken topical treatment of hair loss for at least 4 weeks.
5. Subject who had taken any systemic treatment for at least 3 months.
6. History of alcohol or drug addiction.
7. Subject having history or resent condition of irritated or visibly inflamed scalp or severe scalp disease.
8. Subject having history or present condition of an allergic response to any cosmetic products, any other condition which could warrant exclusion from the study.
9. Pregnant or breast feeding or planning to become pregnant during the study period.
10. History of chronic illness which may influence the cutaneous state.
11. Subject have participated any clinical research study related to hair care products.
12. Subject 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.

Primary outcomes:
measure: Change in hair thickness by using CASLite Nova (instrumental analysis)
timeFrame: 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.
measure: Change in hair density by using CASLite Nova (instrumental analysis)
timeFrame: 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.
measure: Change in hair growth rate using CASLite Nova (instrumental analysis)
timeFrame: 04 before Day 01, Day 01, Day 87, Day 90, Day 177 and on Day 180
Secondary outcomes:
measure: Change in keratin measurement from scalp by using CASLite Nova (instrumental analysis)
timeFrame: 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.
measure: Change in hair length by using CASLite Nova (instrumental analysis) and calibrated ruler
timeFrame: 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
measure: Change in A:T ratio by hair pluck test
timeFrame: Baseline before usage of the test products on Day 01 and after usage of the test products on Day 90 and on Day 180
measure: Change hair fall from root test by 60 seconds hair combing test
timeFrame: 04 before Day 01, Day 87, Day 90, Day 177 and on Day 180
measure: Change in number of new hairs by using CASLite Nova (instrumental analysis)
timeFrame: 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
measure: Change in hair regrowth by using CASLite Nova (instrumental analysis)
timeFrame: 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
measure: Change in hair root strength
timeFrame: 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
measure: Change in general appearance of hair volume
timeFrame: 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
measure: Change in general appearance of hair plasticity
timeFrame: 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
measure: Change in general appearance of hair density
timeFrame: 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
measure: Change in general appearance of hair dryness
timeFrame: 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
measure: Change in general appearance of hair shininess
timeFrame: 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
measure: Change in general appearance of hair smoothness
timeFrame: 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
measure: Change in general appearance of hair oiliness
timeFrame: 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
measure: Change in general appearance of hair strength
timeFrame: 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
measure: Change in general appearance of scalp Itchiness
timeFrame: 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
measure: Change in general appearance of scalp redness
timeFrame: 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
measure: Change in general appearance of scalp roughness
timeFrame: 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
measure: Change in general appearance of scalp scaliness
timeFrame: 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
measure: Change in general appearance of scalp dryness
timeFrame: 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
measure: Change in products perception questionnaire in which 5-point Likert scale as 1= not at all and 5= to large extent
timeFrame: 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
measure: Change in tensile strength of hairs by TESTRONIX tensile tester (instrumental analysis)
timeFrame: Baseline before usage of test product on Day 01 and after usage of test product on Day 180.
Other outcomes:
Locations:
Study officials:
affiliation: NovoBliss Research Pvt Ltd
name: Dr. Nayan K Patel
role: PRINCIPAL_INVESTIGATOR
References: