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CTRI Number  CTRI/2013/01/003283 [Registered on: 02/01/2013] Trial Registered Prospectively
Last Modified On: 11/06/2013
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Cosmetic ]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Evaluate effect and safety Of VB-001, an Antidandruff Hair Oil Regime In Comparison With Head & Shoulders® Antidandruff Shampoo (P&G) Regime In Subjects With Moderate Adherent Dandruff Of The Scalp 
Scientific Title of Study   Efficacy and in use skin safety Of VB-001, an Antidandruff Hair Oil Regime In Comparison With Head & Shoulders® Antidandruff Shampoo (P&G) Regime In Subjects With Moderate Adherent Dandruff Of The Scalp 
Secondary IDs if Any  
Secondary ID  Identifier 
CL/028/1212/STU  Protocol Number 
VYB/CD/001 - Version: 004   Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rajiv Joshi 
Designation  Principal Investigator 
Affiliation  C.L.A.I.M.S. Pvt. Ltd. 
Address  C.L.A.I.M.S Pvt Ltd 4th Floor, B Wing, Modi House, C-10, Dalia Industrial Estate, New Link Road, Andheri (W),

Mumbai
MAHARASHTRA
400058
India 
Phone  66758851  
Fax  66758854  
Email  rsjdr@rediffmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rajiv Joshi 
Designation  Principal Investigator 
Affiliation  C.L.A.I.M.S. Pvt. Ltd. 
Address  C.L.A.I.M.S Pvt Ltd 4th Floor, B Wing, Modi House, C-10, Dalia Industrial Estate, New Link Road, Andheri (W),


MAHARASHTRA
400058
India 
Phone  66758851  
Fax  66758854  
Email  rsjdr@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Abhijit Bapat 
Designation  Director- Clinical Development and Operations 
Affiliation  Vyome Biosciences Private Limited 
Address  Vyome Biosciences Private Limited Plot No. 459 (1st Floor) & 465 (Ground Floor) F.I.E Patparganj Industrial Area Delhi 110092 India

New Delhi
DELHI
110092
India 
Phone  01145152531  
Fax    
Email  abapat@vyome.in  
 
Source of Monetary or Material Support  
Vyome Biosciences Private Limited. Plot No. 459 (1st Floor) & 465 ( Ground Floor) F.I.E. Patparganj Industrial Area Delhi 110092 India  
 
Primary Sponsor  
Name  Vyome Biosciences Private Limited 
Address  Plot No. 459 (1st Floor) & 465 ( Ground Floor) F.I.E. Patparganj Industrial Area Delhi 110092 India  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
None  Not Applicable 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 5  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rajiv Joshi  C.L.A.I.M.S Pvt. Ltd.  4th Floor, B Wing, Modi House, C-10, Dalia Industrial Estate, New Link Road, Andheri (W), Mumbai-400058.
Mumbai
MAHARASHTRA 
66758851
66758854
rsjdr@rediffmail.com 
DrHema Jerajani  MGM Institute of health sciences  Post Box- 06, MGM Educational Campus Sector-18 Kamothe , Navi Mumbai 410 209 , Maharashtra.
Thane
MAHARASHTRA 
09820031483

jerajani@rediffmail.com 
Dr Suneel Vartak   Skin Clinic  Skin Clinic,18 Dehabanu Complex, Near Bytco Point,Nasik Road – 422101 ,
Nashik
MAHARASHTRA 
2466268

suneel.vartak@gmail.com 
Dr Nikhil Kajale   Sparsh Skin Clinic  Sparsh Skin Clinic N-53,VD1,34/1 Patil Nagar, Near Divya Adlabs Complex, Opp. SBI Bank, Nashik-08
Nashik
MAHARASHTRA 
09619841393

niks_kajale@rediffmail.com 
Dr Yatin Jadhav  Springs Skin and Cosmetology Laser Clinic. Pvt. Ltd.  Springs Skin and Cosmetology Laser Clinic. Pvt. Ltd. Jade Garden,Swarvihar Gruha Sankul Khend Chiplun District Ratnagiri 415605 Maharashtra, India
Ratnagiri
MAHARASHTRA 
02355261234
02355260677
springscosmetologyclinic@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Independent Ethics Committee, Mumbai  Approved 
MGM Institute of health Sciences Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Dandruff 
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Intervention  Antidandruff hair oil regime  Antidandruff hair oil (active ingredient Piroctone Olamine) application of 10ml of Product daily, overnight (at least for 8 hours leave on) with massage onto the scalp Subjects will wash their head on the next day of IP application with Pantene Pro Lively Clean® shampoo. This procedure will be continued for 2 weeks.  
Comparator Agent  Head & Shoulders® Shampoo  Subjects will be instructed to apply the antidandruff Head & Shoulders® Shampoo and Pantene Pro V® Non anti Dandruff Conditioner alternate days for 2 weeks.  
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Healthy males or females aged ≥ 15 years and ≤ 65 with a clinical diagnosis of moderate adherent dandruff of the scalp.
2.Understand and willing to sign written informed consent in case of adults and written parental consent form and child assent form in case of children wherever applicable.
3. Must be willing and able to comply with protocol, including measures of subject compliance.
4. Must have active adherent dandruff of the scalp with a minimum score of 6 and not exceeding 14; baseline scaling scoring of at least 3 and not more than 4 of adherent flaking in at least one zone of the scalp (6 zones- 2 frontal, 2 parietal plus temporal and 2 occipital) .
5. Investigators global assessment (IGA) for pruritis score of at least 1.
6. Should not have used an antidandruff agent in the past 14 days.
7. Willing to refrain from use of all other topical medications that would affect the results of the trial, including medicated shampoos/oils or antibiotics, during the treatment and observation periods (from day 0 to day 14).
 
 
ExclusionCriteria 
Details  1. Pregnant or Lactating Women by history.
2. No history of overt bacterial, viral or fungal infection of the head/neck.
3. No history or presence of compromising dermatosis elsewhere on the skin.
4. No actinically damaged skin
5. Presence of any skin condition that would interfere with the diagnosis or assessment of adherent dandruff; e.g., psoriasis, acne, atopic dermatitis.
6. Clinically significant systemic disease (e.g., immunological deficiencies, AIDS, current malignancies, uncontrolled diabetes mellitus).
7. Use within 1 month prior to baseline of any treatment that would affect the results of the trial, including 1) systemic antifungals, 2) systemic steroids 3) systemic antibiotics 4) systemic anti-inflammatory agents or 5) cytostatic or immunomodulating drugs (e.g., cyclosporine, tacrolimus, pimecrolimus).
8. Use within 2 weeks prior to baseline of any treatment that would affect the results of the trial, including 1) topical steroids 2) topical retinoids 3) topical anti-inflammatory agents 4)topical antibiotics or 5) topical treatment of adherent dandruff (e.g., coal tar preparations, antidandruff shampoos/oils/gels/creams/conditioners 6) antihistamines. 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To evaluate efficacy of VB-001, antidandruff hair oil regime in comparison with Head & Shoulders® Antidandruff Shampoo (P&G) regime in subjects with Moderate adherent dandruff of the scalp.  0,5 ,9,and 14 days 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate in use skin safety VB-001, antidandruff hair oil regime in comparison with Head & Shoulders® Antidandruff Shampoo (P&G) regime in subjects with Moderate adherent dandruff of the scalp   0,5 ,9,and 14 days 
 
Target Sample Size
Modification(s)  
Total Sample Size="168"
Sample Size from India="168" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   N/A 
Date of First Enrollment (India)   16/01/2013 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Brief Summary  

·        Subjects will be screened at visit 1, and if they meet the inclusion/exclusion criteria they will be randomized for inclusion.

  • At Visit 2, Day 0, subjects will be allocated to any 1 of the 2 groups as per  randomization  to receive either Antidandruff hair oil (VB-001) or Head & Shoulders® Antidandruff Shampoo (P&G). 
  • Thereafter clinical evaluation of test site will be carried out.
  • Severity of   dandruff and pruritis would be graded using clinical scales.
  •  Photographs of the scalp will be taken at all visits.
  • Subjective questionnaire will be taken at all visits.
  • Baseline data will be captured at Visit 2 (Day 0). Follow-up visits to collect similar data and hence evaluate efficacy of test products will be done at Visit 3 (D05), Visit 4 (D09) and Visit 5 (D14).
  • Product will be dispensed to subjects at Visit 2(D0) and compliance will be checked at all visits.
  • Subjects will be required to maintain a diary to monitor product compliance.
  • The Products will be dispensed for application at home.
  • About 300 volunteers in the age group of 15 – 65 years will be screened to get 168 volunteers (84 in each of 2 groups) for the entire study.
 
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