Health Condition 1: L649- Androgenic alopecia, unspecified
Conditions
Interventions
Intervention1: Hair Growth Serum-1: Mode of Usage- Apply a small amount of serum directly to your fingertips and massage gently into the scalp and roots using circular motions in order to ensure even
instead, allow it to absorb fully.
Frequency- Daily Night application
Storage Condition- Store at room temperature 15 C to 30 C, away from sunlight.
Route of Administration Topical
Dosage Form-Serum
I
instead, allow it to absorb fully. Frequency- Daily Night application Storage Condition- Store at room temperature 15 C to 30 C, away from sunlight. Route of Administration Topical Dosage Form-Serum
C
Sponsors
OneSto Labs Private Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1) Age: 18-55 years (both inclusive) at the time of consent. 2) Sex: Males and non-pregnant or non-lactating females. 3) Females of childbearing potential must have a self-reported negative urine pregnancy. 4) Participant is in good general health as determined by the Investigator on the basis of medical history. 5) Participants 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) Participant 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. 7) If the participant 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. 8) Participants are willing to give written informed consent and are willing to follow the study procedure. 9) Participants who commit not to use any other medicated/ prescription shampoos/hair care products, any other hair growth products or hair colour or dye, other than the test products for the entire duration of the study. 10) Willing to use test products throughout the study period. 11) Participant is willing and able to follow and allow study staff to perform study test methods. 12) Participant is willing and able to follow the study directions, to participate in the study, returning for all specified visits. 13) Participant must be able to understand and provide written informed consent to participate in the study.
Exclusion criteria
Exclusion criteria: 1) Participant have history of severe hair fall due to any clinically significant problems like anaemia, thyroid problems. 2) Participant have history of any dermatological condition of the scalp other than hair loss and dandruff. 3) Participant have history of any prior hair growth procedures (e.g. hair transplant or laser). 4) Participant who had taken topical product of hair loss for at least 4 weeks. 5) Participant who had taken any systemic product for at least 3 months. 6) History of alcohol or drug addiction. 7) Participant having history or resent condition of irritated or visibly inflamed scalp or severe scalp disease. 8) Participant 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) Participant have participated any clinical research study related to hair care products.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To evaluate the effectiveness of the test products in terms of change in hair growth measured in terms of hair length from baseline before and after usage of the test products (from AGA area). 2.To evaluate the effectiveness of the test products in terms of change in hair thickness and hair density from baseline before and after usage of the test products.Timepoint: Baseline on Day 01, Day 30, Day 60 and Day 90. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the effectiveness of the test products in terms of change in A:T ratio from baseline before and after usage of the test products.Timepoint: Baseline on Day 01, Day 30, Day 60 and Day 90.;To evaluate the effectiveness of the test products in terms of change in hair fall from root from baseline (from screening) before and after usage of the test products.Timepoint: Baseline on Day 01, Day 30, Day 60 and Day 90.;To evaluate the effectiveness of the test products in terms of change in general appearance of hair i.e. hair volume, hair plasticity, hair density, hair shininess, hair smoothness, hair oiliness, hair strength and hair dryness from baseline before and after usage of the test products.Timepoint: Baseline on Day 01, Day 30, Day 60 and Day 90.;To evaluate the effectiveness of the test products in terms of change in general appearance of scalp skin i.e. Itchiness, redness, roughness, dryness and scaliness from baseline before and after usage of the test products.Timepoint: Baseline on Day 01, Day 30, Day 60 and Day 90.;To evaluate the effectiveness of the test products in terms of improvement in hairline and bald patches from baseline before and after usage of the test products.Timepoint: Baseline on Day 01, Day 30, Day 60 and Day 90.;To evaluate the effectiveness of the test products in terms of change in numbers of new hairs from baseline and after usage of the test products.Timepoint: Baseline on Day 01, Day 30, Day 60 and Day 90.;To evaluate the effectiveness of the test products in terms of product perception questionnaire through Quality of Life Questionnaire by using 5-point Likert scale from the baseline before and after usage of the test products.Timepoint: Baseline on Day 01, Day 30, Day 60 and Day 90. | — |
Countries
India
Contacts
Public ContactDr Maheshvari Patel
NovoBliss Research Pvt. Ltd.
Outcome results
None listed