Health Condition 1: L659- Nonscarring hair loss, unspecified
Conditions
Interventions
None listed
Sponsors
Vedistry Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1)� Age: 18 to 45 years (both inclusive) at the time of consent. 2)� Sex:� Healthy males and non-pregnant/non-lactating females. 3)� Females of childbearing potential must have a self-reported negative pregnancy test. 4)� Subjects are generally in good health. 5)� Females with 40-50 counts and males with 25-30 counts of hair fall from the hair combing method (60-sec hair count) at the screening visit 1 before treatment. 6)� Subject has mild to moderate dandruff on scalp determined by ASFS score 24 to 48 with itching and flaking at the screening visit. 7) Subjects have unwashed and untreated scalp for 5 days. 8)� All hair colors except grey hair. 9)� � Subject has hair length long enough to pluck the hairs. 10)� The subject who does head massage. 11)� Subjects with self-proclaimed nonpathological thinning of hair. � 12)� Subjects willing to give written informed consent and willing to follow study procedure. 13)� Subjects who have used other marketed products for hair fall control in past. 14)� Willing to refrain from any other treatment for the main indications for which the study test product is being given during the study. 15)� Subjects who commit not to use medicated/ prescription shampoos/hair care products (containing Minoxidil / Anti-hair fall agents) or any other hair growth, hair fall treatment, hair products other than the test product for the entire duration of the study. 16)� Willing to use test products throughout the study period.
Exclusion criteria
Exclusion criteria: 1)Ã? Subjects with a history of severe hair fall due to any clinically significant problems/s like anemia, thyroid problems, etc. 2)Ã? History of any dermatological condition of the scalp other than hair loss and/or dandruff. 3)Ã? History of prior use of scalp hair growth treatment within 3 months. 4)Ã? History of any prior hair growth procedures (e.g., hair transplant or laser). 5)Ã? Subjects who have applied topical treatment for hair loss for at least 4 weeks and any systemic treatment for at least 3 months, before they participated in the study. 6)Ã? History of alcohol or drug addiction. 7)Ã? Subjects using other marketed hair fall control and/or hair growth products during the study period. 8)Ã? Subjects who have plans of shaving of scalp hair during the study. 9)Ã? Subjects who are on chronic oral steroids 03 months before initial application and during the study period. 10)Ã? History or present condition of irritated or visibly inflamed scalp or severe scalp disease. 11)Ã? Subjects having a history or present condition of an allergic response to any cosmetic products. 12)Ã? Any other condition which could warrant exclusion from the study, as per the dermatologistââ?¬•s/investigatorââ?¬•s discretion. 13)Ã? Pregnant or breastfeeding or planning to become pregnant during the study period. 14)Ã? History of chronic illness which may influence the cutaneous state. 15) Subjects participating in other similar cosmetics, device or therapeutic trials or hair / scalp care products within the last four weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Mean Percentage change in hair fall (Khalitya) reduction after 4 and 8 weeks of the application using 60 seconds hair count technique 2) To assess the effect of test treatment in terms of change in hair growth on the scalp using CASlite nova 3) To evaluate the effectiveness of test product on reduction in Adherent scalp flaking scoreTimepoint: 1) Baseline on Day 1 before application to Day 30 and Day 60 after applications 2) Baseline visit (04 days before Day 01) and Visit 2 (Day 01) before application to Visit 03 (Day 27) - Visit 04 (Day 30) and Visit 05 (Day 57) - Visit 06 (Day 60) after application 3) Baseline on Day 01 before application to Day 30 and Day 60 after application | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the effect of test treatment in terms of change in the general appearance of hair (Hair volume, hair density, hair plasticity, hair smoothness, hair oiliness, shininess) Hair Volume: Full - Medium - Small Hair Density: Dense - Thinned/Shed Hair Plasticity: Waved - Flat Hair Smoothness: Poor - Average - Good Hair Oiliness: None - Mild - Moderate - Excessive Hair Shininess: Poor - Average - GoodTimepoint: Baseline on Day 1 before application to Day 30 and Day 60 after applications;To assess the effect of test treatment in terms of product perceptionTimepoint: Baseline on Day 1 before application to Day 30 and Day 60 after applications;To assess the effect of the test treatment in terms of hair Strength (poor, average, good)Timepoint: Baseline on Day 1 before application to Day 30 and Day 60 after applications | — |
Countries
India
Contacts
Public ContactMaheshvari Patel
NovoBliss Research Private Limited
Outcome results
None listed