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CTRI Number  CTRI/2024/05/067755 [Registered on: 21/05/2024] Trial Registered Prospectively
Last Modified On: 30/05/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Methodology Validation Study]  
Study Design  Single Arm Study 
Public Title of Study   Validation of Assessment Methods of Scalp Dandruff in Adult Subjects: Correlating Adherent Scalp Flaking Score and Phototrichogram Analysis 
Scientific Title of Study   Methodology Validation: Correlating Adherent Scalp Flaking Score (ASFS) with Phototrichogram for Scalp Dandruff Evaluation in Adult Subjects 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NB240024-NB-V_1.0_08May24  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Maheshvari Patel 
Designation  Principal Investigator - Director Operations 
Affiliation  NovoBliss Research Private Limited 
Address  NovoBliss Research Pvt. Ltd. Office A - 206, 2nd Floor, Shaligram Lakeview Business Complex, Nr. Vaishnodevi Circle, Khoraj

Gandhinagar
GUJARAT
382421
India 
Phone  09909013236  
Fax    
Email  maheshvari@novobliss.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Nayan Patel 
Designation  Medical Director 
Affiliation  NovoBliss Research Private Limited 
Address  NovoBliss Research Pvt. Ltd. Office A - 206, 2nd Floor, Shaligram Lakeview Business Complex, Nr. Vaishnodevi Circle, Khoraj

Gandhinagar
GUJARAT
382421
India 
Phone  09909013286  
Fax    
Email  dr.nayan@novobliss.in  
 
Details of Contact Person
Public Query  
Name  Dr Nayan Patel 
Designation  Medical Director 
Affiliation  NovoBliss Research Private Limited 
Address  NovoBliss Research Pvt. Ltd. Office A - 206, 2nd Floor, Shaligram Lakeview Business Complex, Nr. Vaishnodevi Circle, Khoraj


GUJARAT
382421
India 
Phone  09909013286  
Fax    
Email  dr.nayan@novobliss.in  
 
Source of Monetary or Material Support  
NovoBliss Research Pvt. Ltd. Office A - 206, 2nd Floor, Shaligram Lakeview Business Complex, Nr. Vaishnodevi Circle, Khoraj, Gandhinagar - 382421 Gujarat, India 
 
Primary Sponsor  
Name  NovoBliss Research Private Limited 
Address  NovoBliss Research Pvt. Ltd. Office A - 206, 2nd Floor, Shaligram Lakeview Business Complex, Nr. Vaishnodevi Circle, Khoraj, Gandhinagar 382421 Gujarat, India 
Type of Sponsor  Contract research organization 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Nayan Patel  NovoBliss Research Private Limited  Clinical Trails Department, NovoBliss Research Pvt. Ltd. Office# A - 206, 2nd Floor, Shaligram Lakeview Business Complex, Nr. Vaishnodevi Circle, Khoraj
Gandhinagar
GUJARAT 		 09909013236

dr.nayan@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 volunteers with scalp dandruff 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Hair-Wash Shampoo  Standard Marketed Hair Wash Shampoo Usage: To be used after baseline evaluations on Day-1 for washing hair - to be followed by another set of evaluations post hair-wash. 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  1. Age between 18 and 55 years (both inclusive).
2. Good general health as determined from recent medical history.
3. No previous history of adverse skin conditions, and not under any medication likely to interfere with the results.
 
 
ExclusionCriteria 
Details  Non-willing subjects and subjects with a history of allergies or specific allergic reactions upon using dermatological/cosmetic products will not be included. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. ASFS: To assess the grade of scaling of the scalp by Dermatologist and Dermatologist-trained evaluator’s assessment, before and after hair wash.
2. Scalp Condition: To assess the condition of the scalp via Phototrichogram using the instrument CASLite Nova, before and after hair wash. 		 On Day 01 for baseline, and post hair-wash on Day 01. 
 
Secondary Outcome  
Outcome  TimePoints 
60-second hair combing test: To assess the amount of non-adherent scalp dandruff flakes using dermatological assessment, before and after hair wash  On Day 01 for baseline, and post hair-wash on Day 01. 
Photographic Documentation: To assess the visible flakes/non-adherent scalp flakes fallen on the shoulders of the subjects, before and after hair wash  On Day 01 for baseline, and post hair-wash on Day 01. 
 
Target Sample Size   Total Sample Size="12"
Sample Size from India="12" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="12" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/06/2024 
Date of Study Completion (India) 23/05/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="0"
Days="1" 
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  

This is an open label, single–arm, single-centre, prospective clinical study to validate the methodology of assessment of scalp flaking/dandruff using various techniques: Adherent Scalp Flaking Scoring by Dermatologist and Dermatologist-trained evaluator, Phototrichogram using CASLite Nova, and 60-second hair combing test for assessing the amount of non-adherent dandruff flakes. Considering the nature of the study, 12 female/male adult subjects with having mild to moderate scalp dandruff will be recruited/enrolled. The potential subjects will be screened as per the inclusion & exclusion criteria only after providing them with the Subject Information Sheet.

1.       Visit 01 (Day 01): Screening, Enrolment, Evaluations

 
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