Health Condition 1: L659- Nonscarring hair loss, unspecified
Conditions
Interventions
Intervention1: Hair Fall Control Oil Shots: Contains Caprylic/Capric Triglyceride (fractionated coconut oil), Allium Cepa (Onion) Bulb Extract, Coffea Arabica (Coffee) Seed Oil, Helianthus Annuus (Sun
Sponsors
Brillare Science Private Limited
Not Applicablele
Eligibility
Inclusion criteria
Inclusion criteria: 1) Age: 18 to 65 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 product application. 6) Subjects have unwashed and untreated scalp for 5 days. 7)� All hair colours except grey hair. 8)� The subject who does head massage. 9)Subjects with self-proclaimed nonpathological thinning of hair. � 10)Subjects willing to give written informed consent and willing to follow study procedure. 11)Subjects who have used other marketed products for hair fall control in past. 12)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. 13)Willing to use test product throughout the study period.
Exclusion criteria
Exclusion criteria: 1)Subjects with a history of severe hair fall due to any clinically significant problems/s like anaemia, 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) 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)Ã? Subjects participating in other similar cosmetics, devices or therapeutic trials or hair/scalp care products within the last four weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean percentage change in hair fall reductionTimepoint: Baseline on Day 1 before application to Day 02 (1st Wash) and on Day 15 after applications | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the effect of test product in terms of change in the general appearance of hair --- Hair Volume, Hair Density, Hair Plasticity, Hair smoothness, Hair Oiliness, Shininess after 15 Days (2 weeks) of application Evaluated by the Dermatologist Trained Evaluator | Dermatologist.Timepoint: Baseline on Day 1 before application to Day 15 after applications;To assess the effect of test product in terms of product perception after 15 Days of product applications using the subjective perception questionnaires about the productTimepoint: Baseline on Day 01 before application to Day 15 after applications;To assess the effect of the test product in terms of hair strength -- poor, average, good evaluated by the Dermatologist Trained Evaluator | DermatologistTimepoint: Baseline on Day 1 before application to Day 15 after applications;To assess the effect of the test product in terms of Scalp Appearance Ã? --- itchiness, redness, roughness, and scaliness of scalp after 15 days (2 weeks) of application evaluated by the Dermatologist Trained Evaluator | DermatologistTimepoint: Baseline on Day 1 before application to Day 15 after applications;To assess the effect of the test product in terms of Scalp Hydration using MoistureMeterEpidD instrumentTimepoint: Baseline on Day 1 before application to Day 15 after applications | — |
Countries
India
Contacts
Public ContactMaheshvari Patel
NovoBliss Research Private Limited
Outcome results
None listed