| CTRI Number |
CTRI/2023/07/055057 [Registered on: 11/07/2023] Trial Registered Prospectively |
| Last Modified On: |
21/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmeceutical] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical Study on H-Vit Hair Serum for Hair Growth Potential |
|
Scientific Title of Study
|
An Open Label, Prospective, Non-Comparative, Single Arm Clinical Study to Evaluate the Efficacy, Safety and Tolerability of H-Vit Hair Serum of Systopic Laboratories Pvt. Ltd. in Hair Fall Control, Hair Growth Potential and Improvement in Hair Health in Adult Volunteers |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| AHC/DER/085/23 Version 01 09-May-23. |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr VT Sriraam |
| Designation |
Investigator |
| Affiliation |
Aurous HealthCare R&D India Pvt. Ltd. |
| Address |
No. 128, Sakthy Flats, NTR Garden Street, Flats 01&02, Ground Floor
Rangarajapuram Main Road, Kodambakkam,
Chennai
TAMIL NADU
600024
India |
| Phone |
09840909155 |
| Fax |
|
| Email |
md@auroushealthcare.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr VT Sriraam |
| Designation |
Investigator |
| Affiliation |
Aurous HealthCare R&D India Pvt. Ltd. |
| Address |
No. 128, Sakthy Flats, NTR Garden Street, Flats 01&02, Ground Floor
Rangarajapuram Main Road, Kodambakkam,
TAMIL NADU
600024
India |
| Phone |
09840909155 |
| Fax |
|
| Email |
md@auroushealthcare.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr VT Sriraam |
| Designation |
Investigator |
| Affiliation |
Aurous HealthCare R&D India Pvt. Ltd. |
| Address |
No. 128, Sakthy Flats, NTR Garden Street, Flats 01&02, Ground Floor
Rangarajapuram Main Road, Kodambakkam,
TAMIL NADU
600024
India |
| Phone |
09840909155 |
| Fax |
|
| Email |
md@auroushealthcare.com |
|
|
Source of Monetary or Material Support
|
| Systopic laboratories Private Limited
101, Pragati Chambers, Commercial Complex, Ranjit Nagar, New Delhi-110008. |
|
|
Primary Sponsor
|
| Name |
Systopic laboratories Private Limited, |
| Address |
101, Pragati Chambers, Commercial Complex,
Ranjit Nagar, New Delhi-110008.
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Aurous HealthCare Research and Development India Private Limited |
128, Shakthy Flats, NTR garden Street, Flats 01and 02, Ground Floor Rangarajapuram main road, Kodambakkam, Chennai, 600024.Tamil Nadu |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr VT Sriraam |
Raam Clinic |
Room no 1, Department of General Medicine
128, Shakthy Flats, NTR garden Street, Flats 01and 02, Ground Floor Rangarajapuram main road, Kodambakkam, Chennai, 600024.Tamil Nadu
Chennai
TAMIL NADU |
9840909155
md@auroushealthcare.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Universal Ethics Committee (A Unit of Aurous HealtCare Research and Development India Pvt. Ltd ) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Clinically healthy adult subjects between the ages of 21 and 55 years both ages and all genders inclusive looking to improve their hair health. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
H-Vit Hair Serum |
Product is provided in a 60 ml bottle with spray nozzle
Spray the product on the palm of one hand.
Rub hands together to spread the product
Apply the product from root to tip, spreading evenly
Apply once a day anytime
There is no need to wash hair after applying the product
Treatment Duration: 90 days
Route of Administration : Topical
|
| Comparator Agent |
Not applicable. |
Not applicable. |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Clinically healthy adult subjects between the ages of 21 and 55 years both ages and all genders inclusive looking to improve their hair health.
2. Subjects who agree not to dye or colour, cut or trim, straightening or other cosmetic treatments and or under go any hair treatments not limited to hair spa at beauty saloons or parlours for the duration of participation in the clinical study.
3. Subjects with complaints of non associated excessive hair fall, brittle or thin hair, dry or damaged hair.
4. Subjects who are willing to abstain from the use of any dedicated products not limited to hair oil, shampoo, conditioner, hair mask, hair serum, hair treatments and remedies to improve hair fall and other hair health parameters.
5. Subjects who are willing to abstain from the use of any oral or tropical medications not limited to collagen, biotin supplements indicated and improving hair fall and other hair health parameters.
6. Subjects who are willing to give informed consent for participation, able to comprehend ad understand the responsibilities during screening and treatment period
7. Subjects who are willing not to participate in any other clinical trial during participation in the current trial.
|
|
| ExclusionCriteria |
| Details |
1. Subjects with known hypersensitivity to the ingredients of the investigational product.
2. Subjects who have had an active trichological procedure done upto 3 months prior to screening
Subjects who have dyed their hair upto 30 days prior to screening
3. Subjects who have scalp conditions not limited to seborrheic dermatitis, psoriasis, alopecia areata, significant scalp scarring that prevents proper examination or evaluation of study criteria.
4. Subjects with Trichotillomania
5. Subjects who have anemia or iron deficiency.
6. Subjects who have previously undergone hair transplantation procedures.
7. Subjects who have an active infection, disease or disorder that will prevent them from fully satisfying their responsibilities of the study.
8. Subjects with history of seizures, uncontrolled diabetes, hypertension or major cardiac illness like congestive heart failure etc.
9. Subjects suffering from, on remission from cancer of any type less than 5 years at the time of screening.
10. Subjects who are planning a pregnancy and, or currently breastfeeding
11. Subjects who have participated in a clinical trial less than 1 month before screening.
12. Any significant medical condition e.g., significant psychiatric or neurological disorders, active alcohol or drug abuse etc., any medical condition that unstable, poorly controlled or other factor e.g., planned relocation that the investigator felt would interfere with study evaluations and study participation.
13. Subjects who mentally unable to comprehend the responsibilities and adhere to the stipulations of the protocol
14. Subjects who in the opinion of the investigator are not eligible for enrolment in the study
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. 60 Second Hair Comb Test: Reduction of greater than or equal to 50 percent from Baseline
2. Visual Scalp Assessment: Increase of greater than or equal to 10 scores from base line
3. Hair Growth Questionnaire: Total score lesser than or equal to 10 at end of study
4. Product Satisfaction Questionnaire: Total score of greater than or equal to 5 at end of study
|
1. 60 Second Hair Comb Test : Day 1, Day 45, Day 90
2. Visual Scalp Assessment : Day 1, Day 45, Day 90
3. Hair Growth Questionnaire : Day 45, Day90
4. Product Satisfaction Questionnaire : Day90
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not applicable |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
31/07/2023 |
| Date of Study Completion (India) |
22/10/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Study Design : Open label, Prospective, Non Comparative Non
Randomised, Single Arm Clinical Study
Indication : Hair Growth Potential, Hair Fall Control, Hair
Health Parameters.
Investigational Product : H-Vit Hair Serum of Systopic
Laboratories Pvt. Ltd.
Comparator: Not Applicable. Single Arm Non Comparative
Study
Dose/Dosage: Product is provided in a 60ml bottle with a
spray nozzle.Spray the product on the palm of one hand. Rub hands together to
spread the product. Apply the product on hair from root to tip, spreading
evenly. Apply once a day at any time
Subject Population: Clinically Healthy adult subjects between the
ages of 21 and 55 years both ages and al genders inclusive looking to improve
their hair health
Number of Subjects : 40Evaluable Subjects
Treatment Arms:1
Treatment Duration:90 Days
Efficacy
Assessments
1. 60 Second Hair Comb Test : Day 1, Day 45, Day 90
2. Visual Scalp Assessment Test : Day1.Day 45, Day 90
3. Hair Growth Questionnaire: Day 45,Day 90
4. Product Satisfaction Questionnaire: Day 90
Safety Assessment: Monitoring of the severity and frequency of
adverse events
Background of the study: Cosmetics specifically
cosmeceuticals are becoming more high demand and in daily life. It is used
frequently by many. Many use various products to enhance beauty and elegance to
look young. Cosmetics thus play a vital role in human life. Hair is one of the
primary part of the human body that adds beauty and also acts as a protective
appendage.
Hair Serum is a styling product that coats the surface of the hair. However, it
is not just meant for styling. They could also treat multiple hair concerns
like dry hair, dull hair and unmanageable hair. Hair serum can effectively
smoothen, protect from environmental aggressors, reduce tangles, boosts
smoothness all of which improves hair health, reduced the likelihood of excessive
hair fall, thereby increasing hair growth potential.
Purpose of the Study : H-Vit Hair Serum by Systopic
Laboratories is a cosmeceutical product that is designed with select
ingredients specifically targeting the cosmetic aspects of a hair serum such as
improvement in hair shine, smoothness, detangler, protection from environmental
aggressor while also working towards reducing hair fall and improving hair
growth potential thereby contributing to overall hair health. This clinical
study is done evaluate the safety and Tolerability of H-Vit Hair Serum of
Systopic Laboratories Pvt. Ltd in Hair Fall Control, Hair Growth Potential and
improvement in Hair health in adults. |