None listed
Conditions
Interventions
Intervention1: Dandruff Control Oil Shots: CAPRYLIC/CAPRIC TRIGLYCERIDE (FRACTIONATED COCONUT OIL), SALVIA SCLAREA (CLARY SAGE) OIL, MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL, AZADIRACHTA INDICA (NEE
Sponsors
Brillare Science Private Limited
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) Subject has mild to moderate dandruff on scalp determined by ASFS score 24 to 48 with itching and flaking at the screening visit. 6) Subjects have unwashed and untreated scalp for 3-5 days. 7) All hair colors 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 the study procedure. 11) Subjects who have used other marketed products for Dandruff control in past. 12) Subjects who commit not to use medicated/ prescription shampoos/hair care products (containing Minoxidil / Anti-hair fall agents / Anti-Dandruff) or any other hair growth, hair fall treatment, dandruff control, 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 anemia, thyroid problems, etc. 2) History of any dermatological condition of the scalp other than hair loss and/or dandruff. 3) History of prior use of scalp hair growth treatment within 3 months. 4) History of any prior hair growth procedures (e.g., hair transplant or laser). 5) 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) Subjects using other marketed scalp dandruff control products during the study period. 8) Subjects who have plans of shaving of scalp hair during the study. 9) Subjects who are on chronic oral steroids 03 months before initial application and during the study period. 10) History or present condition of irritated or visibly inflamed scalp or severe scalp disease. 11) Subjects having a history or present condition of an allergic response to any cosmetic products. 12) Any other condition which could warrant exclusion from the study, as per the dermatologistââ?¬•s/investigatorââ?¬•s discretion. 13) Pregnant or breastfeeding or planning to become pregnant during the study period. 14) History of chronic illness which may influence the cutaneous state. 15) Subjects participating in other similar cosmetics, dandruff control, device or therapeutic trials or hair/scalp care products within the last four weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Mean percentage change on reduction in adherent scalp flaking score - ASFS 2) To assess the effect of the test product in terms of number of applications/washes to get complete relief from Scalp Dandruff through adherent scalp flaking score - ASFSTimepoint: Baseline on Day 01 before application to Day 2 After 1st application wash and every alternate day, Day 04 (2nd wash), Day 06 (3rd wash), Day 08 (4th wash), Day 10 (5th wash), Day 12 (6th wash), Day 14 (7th wash), Day 16 (8th Wash) after applications | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the effect of the test product in terms of change in the general appearance of hair - Hair Volume, Hair Density, Hair Reflection, Hair Plasticity, Hair Smoothness, Hair Oiliness, Shininess after 15 Days (2 weeks) every alternate day of applicationTimepoint: Baseline on Day 01 before application to Day 16 after application;To assess the effect of the test product in terms of hair strength - poor, average, good after 15 days (2 weeks) every alternate day of applicationTimepoint: Baseline on Day 01 before application to Day 16 after applications;To assess the effect of the test product in terms of product perception after 15 Days (2 weeks) every alternate day of applicationsTimepoint: Baseline on Day 01 before application to Day 16 after application using the subjective perception questionnaires about the product;To assess the effect of the test product in terms of Scalp Appearance - itchiness, dryness, redness, roughness, and scaliness of scalp after 15 days (2 weeks) every alternate day of applicationTimepoint: Baseline on Day 01 before application to Day 16 after application;To assess the effect of the test product in terms of Scalp Hydration after 15 Days (2 weeks) every alternate day applications using the MoistureMeterEpidD instrumentTimepoint: Baseline on Day 01 before application to Day 16 post applications;To evaluate the effectiveness of test Product in terms of Scalp Dandruff using PhototrichogramTimepoint: In 1st wash and after 15 days (2 weeks) every alternate day applications on Day 16 post applications;To evaluate the effectiveness of the test product in terms of Scalp Dandruff using PhototrichogramTimepoint: After 1st wash (on Day 2), Day 04 (2nd wash), Day 06 (3rd wash), Day 08 (4th wash), Day 10 (5th wash), Day 12 (6th wash), Day 14 (7th wash), Day 16 (8th Wash) | — |
Countries
India
Contacts
Public ContactMaheshvari Patel
NovoBliss Research Private Limited
Outcome results
None listed