To determine the safety and effectiveness of Dandruff ControlOil Shots in dandruff reduction in Healthy Adult HumanSubjects with Dandruff on the scalp
- Registration Number
- CTRI/2022/04/041701
- Lead Sponsor
- Brillare Science Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 16
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1) Mean percentage change on reduction in adherent scalp flaking score - ASFS <br/ ><br>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 Outcome Measures
Name Time Method