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CTRI Number  CTRI/2022/04/041710 [Registered on: 07/04/2022] Trial Registered Prospectively
Last Modified On: 09/06/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Personal Care (Hair Care) Product]  
Study Design  Single Arm Study 
Public Title of Study   To determine the safety and effectiveness of Hair Fall Control Oil Shots in hair fall reduction in Healthy Adult Human Subjects with Hair Fall 
Scientific Title of Study   A Proof-Of-Concept, Safety and Efficacy study of Hair Fall Control Oil Shots to Evaluate Reduction in Hair Fall in Healthy Adult Human Subjects with Hair Fall 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NB220007-BS, Version No 01 (Final) Dated 25Mar22  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nayan Patel 
Designation  Principal Investigator - Medical Director 
Affiliation  NovoBliss Research Private Limited 
Address  Office A - 206, 2nd Floor, Shaligram Lakeview Business Complex, Near Vaishnodevi Circle, Khoraj, Gandhinagar – 382421 Gujarat - India

Gandhinagar
GUJARAT
382421
India 
Phone  91-9909013286  
Fax    
Email  dr.nayan@novobliss.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Nayan Patel 
Designation  Principal Investigator - Medical Director 
Affiliation  NovoBliss Research Private Limited 
Address  Office A - 206, 2nd Floor, Shaligram Lakeview Business Complex, Near Vaishnodevi Circle, Khoraj, Gandhinagar – 382421 Gujarat - India

Gandhinagar
GUJARAT
382421
India 
Phone  91-9909013286  
Fax    
Email  dr.nayan@novobliss.in  
 
Details of Contact Person
Public Query  
Name  Maheshvari Patel 
Designation  Director Operations and Strategic Management 
Affiliation  NovoBliss Research Private Limited 
Address  Office A - 206, 2nd Floor, Shaligram Lakeview Business Complex, Near Vaishnodevi Circle, Khoraj, Gandhinagar – 382421 Gujarat - India

Gandhinagar
GUJARAT
382421
India 
Phone  91-9909013236  
Fax    
Email  maheshvari@novobliss.in  
 
Source of Monetary or Material Support  
NovoBliss Research Private Limited Department - Clinical Trials Office A - 206, 2nd Floor, Shaligram Lakeview Business Complex, Near Vaishnodevi Circle, Khoraj, Gandhinagar – 382421 Gujarat - India 
 
Primary Sponsor  
Name  Brillare Science Private Limited 
Address  D-603 Ganesh Meridian, Near Gujarat High Court, S.G. Highway, Ahmedabad 380060 Gujarat, India 
Type of Sponsor  Other [Manufacturing of Cosmetics, Personal Care, Wellness products] 
 
Details of Secondary Sponsor  
Name  Address 
Not Applicablele  Not Applicable 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Maheshvari Patel  NovoBliss Research Private Limited  Office A - 206, 2nd Floor, Department - Clinical Trials, Shaligram Lakeview Business Complex, Nr. Vaishnodevi Circle, Khoraj, Gandhinagar – 382421, Gujarat - India
Gandhinagar
GUJARAT 		 9909013236

maheshvari@novobliss.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ACEAS – Independent Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy Adult Human Subjects with Hair Fall complaints Females with 40-50 counts and males with 25-30 counts of hair fall from the hair combing method at the screening before product application 
Patients  (1) ICD-10 Condition: L659||Nonscarring hair loss, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Hair Fall Control Oil Shots  Contains Caprylic/Capric Triglyceride (fractionated coconut oil), Allium Cepa (Onion) Bulb Extract, Coffea Arabica (Coffee) Seed Oil, Helianthus Annuus (Sunflower) Seed Oil, Glycine Soja (Soybean) Oil, Perfume (natural essential oil blend), Ocimum Bailicum (Basil) Oil, Ocimum Bailicum (Basil) Hairy Root Culture extract, Cocos Nucifera (Coconut) Oil, Olea Olea Eupopaea (Olive Oil) fruit oil, Alpha-tocopherol (Natural Vitamin E), Triticum Vulgare Germ (Wheat Germ) Oil, Vanillyl Butyl Ether (Capsaicin Derivative) takes complete care of hair and scalp with multiple benefits Mode of Usage: Unplug the vial of booster oil shots. Apply one vial at a time on the scalp using a dropper. Penetrate with fingertips massage for 3-5 minutes. Use every alternate night before bed for 15 Days. Next day morning wash your hair and scalp Treatment Duration: 15 Days Route of Administration: Topical 
Comparator Agent  Not Applicable  Not Applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  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)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 product application.
6) Subjects have unwashed and untreated scalp for 5 days.
7) All hair colours 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 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, hair products other than the test product for the entire duration of the study.
13)Willing to use test product throughout the study period. 
 
ExclusionCriteria 
Details  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 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 hair fall control and/or hair growth 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 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. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Mean percentage change in hair fall reduction   Baseline on Day 1 before application to Day 02 (1st Wash) and on Day 15 after applications 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the effect of the test product in terms of Scalp Hydration using MoistureMeterEpidD instrument  Baseline on Day 1 before application to Day 15 after applications  
To assess the effect of test product in terms of change in the general appearance of hair --- Hair Volume, Hair Density, Hair Plasticity, Hair smoothness, Hair Oiliness, Shininess after 15 Days (2 weeks) of application Evaluated by the Dermatologist Trained Evaluator | Dermatologist.  Baseline on Day 1 before application to Day 15 after applications 
To assess the effect of the test product in terms of Scalp Appearance  --- itchiness, redness, roughness, and scaliness of scalp after 15 days (2 weeks) of application evaluated by the Dermatologist Trained Evaluator | Dermatologist  Baseline on Day 1 before application to Day 15 after applications 
To assess the effect of the test product in terms of hair strength -- poor, average, good evaluated by the Dermatologist Trained Evaluator | Dermatologist  Baseline on Day 1 before application to Day 15 after applications 
To assess the effect of test product in terms of product perception after 15 Days of product applications using the subjective perception questionnaires about the product  Baseline on Day 01 before application to Day 15 after applications 
 
Target Sample Size   Total Sample Size="15"
Sample Size from India="15" 
Final Enrollment numbers achieved (Total)= "16"
Final Enrollment numbers achieved (India)="16" 
Phase of Trial   N/A 
Date of First Enrollment (India)   11/04/2022 
Date of Study Completion (India) 27/04/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="0"
Days="25" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 Under Development 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   The rationale of the study is to evaluate the health claims of this hair fall control oil shot which is a mixture of multiple herbal oils which are well known traditionally to improve hair fall by strengthening and nourishing the hair roots and improving hair and scalp health. Each oil is useful to treat hair and scalp related diseases. This clinical study is to investigate the proof of science/concept, safety and efficacy of Hair Fall Control Oil shots to improve hair fall in healthy adult human subjects with hair fall complaints. The study would demonstrate that continuous care of hair and scalp with regular usage of test Hair fall control oil shot throughout the hair growth life cycle would help in reducing hair fall. 
This is an open-label, single-arm, single-centre, proof-of-concept, safety and efficacy, a clinical study of a Hair Fall Control Oil Shots in hair fall reduction in 18 to 65 years old healthy adult human subjects with hair fall after consecutive 2-weeks of usage. Total 8 oil shots will be applied by the subjects in 15 days (2 weeks) on every alternative day. 
The potential subjects will be screened as per the inclusion and exclusion criteria only after obtaining a written informed consent form from the subjects before doing any evaluations.
There will be 03 visits during the conduct of the study. The duration of the study will be 15 days with +2 days window period from enrolment. 

- Visit 01 (Day 01): Screening, Enrolment, 60seconds Hair Combing test, other evaluations before product application
- Visit 02 (Day 02): 60seconds Hair Combing test [1st wash at NovoBliss Site - After Single Shot application
- Visit 03 (Day 16): Evaluation Visit, End of study [Week 2]

During this clinical study, each study activity will be performed per standardized method established at/By NovoBliss Research during an in-house Validation study to have maximum consistency and minimal inter-observer and inter-operator variability. 





 
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