Health Condition 1: L659- Nonscarring hair loss, unspecified
Conditions
Interventions
Intervention1: 15-20 % Fermented Extract Hair Growth and Scalp Health Serum: Mode of Usage: Apply the serum directly to the scalp using the rollerball applicator. Gently roll the ball over thinning or
Sponsors
Blossom Microbiotics LLC
Eligibility
Inclusion criteria
Inclusion criteria: 1) Age 18-55years (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 must have a confirmed diagnosis of mild to moderate hair thinning, during clinical study and grade will be evaluated by the dermatologist by using Norwood-Hamilton classification for male (Grade 1 3) and Ludwig pattern scale for female (Grade 1 2) with active hair shredding 6) 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. 7) 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. 8) Subjects are willing to give written informed consent and are willing to follow the study procedure. 9) Subjects 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 treatment for the entire duration of the study. 10) Subject is willing and able to comply with study procedures, including all scheduled visits, treatment applications, and assessments. 11) Subject is willing and able to follow the study directions, to participate in the study, returning for all specified visits. 12) Subject must be able to understand and provide written informed consent to participate in the study.
Exclusion criteria
Exclusion criteria: 1) Subject have history of severe hair fall due to any clinically significant self-reported problems like anaemia, thyroid problems. 2) Subject have history of any prior hair growth procedures done hair transplant or laser. 3) Subject who had taken topical product of hair loss for at least 4 weeks before enrolment. 4) Subject who had taken any systemic product for any illnesses for at least 3 months. 5) History of alcohol or drug addiction. 6) Subject having history or resent condition of severely irritated or visibly inflamed scalp or severe scalp disease. 7) Subject having history or present condition of an allergic response to any cosmetic products, any other condition which could warrant exclusion from the study. 8) Pregnant or breast feeding or planning to become pregnant during the study period. 9) History of chronic illness which may influence the cutaneous state. 10) Subject have participated any clinical research study related to hair care products. 11) Subject have history of mastectomy for cancer involving removal of lymph nodes within the past year, or product of any type of cancer within the last 6 months. 12) Participants with advanced baldness Norwood 4 7, Ludwig 3, long-standing bald patches more than 1 year, scarring alopecia, active scalp infections, recent use of hair growth treatments minoxidil or finasteride within the past 3 months, severe scalp conditions, or known allergies to any test product ingredients will be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Improvement in Hair Growth Rate evaluated through CASLiteNova from the tattoo markerd area from baseline on- 4 days prior to Day 01, on Day 01(prior to treatment usage)to post treatment assessments on Day 42(+2 Days), Day 45(+2 Days), Day 87 (+2 Days) and Day 90(+2 Days), assessed within each treatment arms and across treatment arms. 2.Improvement in Hair Growth in term of hair length evaluated through CASLiteNova, from baseline (Day 01, prior to treatment usage) to post treatment assessments on Day 45 (+2 Days) and Day 90 (+2 Days), assessed within each treatment arms and across treatment arms. 3.Improvement in Hair Density and Hair thickness evaluated through CASLiteNova, from baseline (Day 01, prior to treatment usage) to post treatment assessments on Day 45 (+2 Days) and Day 90 (+2 Days), assessed within each treatment arms and across treatment arms. Timepoint: 1.On- 4 days prior to Day 01, on Day 01, Day 42(+2 Days), Day 45(+2 Days), Day 87 (+2 Days) and Day 90(+2 Days). 2. Day 01, Day 45(+2 Days), Day 90(+2 Days) 3. Day 01, Day 45 (+2 Days) and Day 90 (+2 Days) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Improvement in Scalp Condition evaluated through CASLiteNova, from baseline to post treatment assessments assessed within each treatment arms and across treatment arms.Timepoint: Baseline on Day 01, Day 45, Day 90;2. Improvement in A:T Ratio evaluated through CASLiteNova, from baseline prior to treatment usage to post treatment assessments, assessed within each treatment arms and across treatment arms.Timepoint: Baseline on Day 01, Day 45, Day 90;3. Improvement in total hair count on the vertex (head crown) region of the scalp evaluated through digital photography capture at 90 angle and analyzed through image pro analysis, from baseline- prior to treatment usage to post treatment assessments, assessed within each treatment arms and across treatment arms.Timepoint: Baseline on Day 01, Day 45, Day 90;4. Improvement in general appearance of scalp i.e. itchiness, redness, roughness, scaliness and dryness evaluated by the Dermatologist or Dermatologist trained evaluator, from baseline- prior to treatment usage to post treatment assessments, assessed within each treatment arms and across treatment arms.Timepoint: Baseline on Day 01, Day 45, Day 90;5. Improvement in general appearance of hair i.e. hair volume, hair plasticity, hair density, hair shininess, hair smoothness, hair dryness and hair strength evaluated by the Dermatologist or Dermatologist trained evaluator, from baseline- prior to treatment usage to post treatment assessments, assessed within each treatment arms and across treatment arms.Timepoint: Baseline on Day 01, Day 45, Day 90;6. Improvement in hair fall- both from the scalp root and due to hair shaft breakage evaluated through 60 second hair combing test by dermatologist trained evaluator, from baseline- prior to treatment usage to post treatment assessments, assessed within each treatment arms and across treatment arms.Timepoint: Baseline on Day 01, Day 45, Day 90;7. Improvement in hair root strength evaluated through hair pull test by dermatolo | — |
Countries
India
Contacts
Public ContactMaheshvari Patel
NovoBliss Research Pvt. Ltd.
Outcome results
None listed