In this study the safety as well as effect of Hair serum will be checked in healthy adult male and female volunteers with hairfall.
- Registration Number
- CTRI/2019/08/020742
- Lead Sponsor
- Sami Labs Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1 Male and female subjectsâ?? in general good health.
2 Subjects in the age group 25 to 45 years (both the ages inclusive).
3 Subjects willing to give a written informed consent and agree to come for a regular follow up visit.
4 Hair density of greater than 100 and less than 200 hair follicle per square cm as per Trichoscan measurement
5 Female Subjects falling under Grade 3 - Grade 6 of hair loss severity grade evaluated as per photo numerical10-point scale (Linear scale for assessment purpose-MSCR Scale).
6 Male subjects falling under Grade 3â?? Grade 6 of hair loss severity grade evaluated as per photo numerical10-point scale (Linear scale for assessment purpose - MSCR Scale).
7 Subjects willing to abide by and comply with the study protocol.
8 Subjects who have not participated in a similar investigation in the past three months.
9 Subjects complaining of hair fall and damage.
10 Healthy volunteers with no known allergy as established by medical history.
11 Subjects who do not smoke or drink
12 Subjects who are not crash dieting.
13 Subjects who agree to refrain from using hair dye/hair colour during the study period.
14 Subjects willing to refrain from any type of hair treatment like perming, straightening etc. during the study duration.
15 Subjects who are willing to refrain from any other oil treatment/hair spa and oral medications for hair growth during the study.
1 Subjects who have undergone hair growth treatment within 3 months before screening into the study.
2 Subjects having any active scalp diseasesuch as scalp Psoriasiswhichmayinterfere in the study- dermatologistâ??s judgement.
3 Subjects who have taken chemotherapy for cancer in the 6 months prior to start of the study or have a plan to do treatments during study.
4 Subjects who have history of alcoholism and/ or psychiatric disorder including trichotillomania.
5 Subjects who have had hair transplant.
6 Subjects who take pharmaceutical product which cause hirsutism (ex. phenytoin) and finesteride for androgenic alopecia.
7 Subjects with a known history or present condition of allergic response/hypersensitivity to any cosmetic ingredients and pharmaceutical products.
8 Subjects consuming alcohol and smoking
9 Subjects on oral medications such as vitamin supplements, including multi-vitaminswhich will compromise the study.
10 Subjects who are pregnant or lactating or nursing as established with medical history
11 Subjects under medical treatment for hair problems, prescription drugs such as Minoxidil, Finasteride, or any 5 α-reductase inhibitor or light therapy.
12 Subjects undergoing any chemical hair salon treatment-straightening/perming/colour.
13 Menopausal female subjects as determined by medical history.
14 Subjects with chronic illness which may influence the cutaneous state.
15 Subjects participating in other similar cosmetic or therapeutic trial within last three months.
16 Subjects with medical history of thyroid disorders.
17 Subjects with any history of underlying uncontrolled medical illness including diabetes mellitus, hypertension, HIV, hepatitis, severe anemia, serious disorder of heart and respiratory apparatus or any other serious medical illness.
18 Subjects who have experienced a known stressful event within the last 6 months such as death in family, miscarriage etc.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1 Hair pull test & Hair Comb test <br/ ><br>2 QOL Questionnaire <br/ ><br>3 Dermatological assessment for hair loss <br/ ><br>4 Dermatological assessment for site application reaction <br/ ><br>5 Phototrichogram imaging <br/ ><br>6 Digital Imgaing <br/ ><br>7 Subject self assessment <br/ ><br>8 Subject assessment for application site reactionTimepoint: 1 Hair pull test & Hair Comb test(Day0,30,60,90) <br/ ><br>2 QOL Questionnaire(Screening & Day90) <br/ ><br>3 Dermatological assessment for hair loss(Screening,Day0,30,60&90) <br/ ><br>4 Site application reaction assessment(Day0,30,60&90) <br/ ><br>5 Phototrichogram imaging(Screening,Day0,30,60&90) <br/ ><br>6 Digital Imgaing(Day0,30,60&90) <br/ ><br>7 Subject self assessment(Day0,30,60&90) <br/ ><br>8 Subject assessment for application site reaction(Day0,30,60&90)
- Secondary Outcome Measures
Name Time Method Safety assessmentTimepoint: Safety assessment throughout the study duration.