To assess the Safety and Effectiveness of Hair Growth Promoting Product in Healthy Adult Human Subjects with Hair Fall Complaints
- Registration Number
- CTRI/2022/11/047330
- Lead Sponsor
- Anveya Living Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 29
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 test product usage.
6)Subject has hair length long enough to pluck the hairs.
7)Subjects have unwashed and untreated scalp for 5 days.
8)All hair colours except grey hair.
9)Subjects with self-proclaimed nonpathological thinning of hair.
10)Subjects are willing to give written informed consent and are willing to follow the 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, or 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 anaemia, 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 hair fall control | 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 hair fall control and/or hair growth products during the study period.
8)Subjects who have plans of shaving 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 dermatologist’s/investigator’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, devices 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. Improvement in Hair Growth Rate, Hair thickness, Hair Density, and Scalp condition in healthy adult human subjects with hair fall using CASLite Nova. <br/ ><br>2. To assess the improvement in hair growth phase using Trichogram-Anagen: Telogen Hair ratio using Pluck Test <br/ ><br>Timepoint: 1. From Baseline to Day 01 before test product usage, and Day 27, Day 30, Day 57, and Day 60 post test product usage <br/ ><br>2. before test product usage from baseline to day 60 post test product usage.
- Secondary Outcome Measures
Name Time Method