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CTRI Number  CTRI/2012/08/002876 [Registered on: 09/08/2012] Trial Registered Prospectively
Last Modified On: 31/12/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Cosmetic]  
Study Design  Single Arm Study 
Public Title of Study   A clinical trial to find the efficacy and safety of Tubby nutririch lotion for the treatment of dry skin in infants and children. 
Scientific Title of Study   A prospective, open label clinical trial to evaluate the efficacy and safety of Tubby nutririch lotion for the treatment of dry skin with or without Atopic tendency in infants and children. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
ICBio/CR/ SM/0602/14 version 01 dated 02.06.2012  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr J Prasad  
Designation  Cosmetologist 
Affiliation  Revive Cosmetic Clinique 
Address  Revive Cosmetic Clinique #72, 2nd Road, Nandidurga Extn, Jayamahal Bangalore 560 046

Bangalore
KARNATAKA
560 046
India 
Phone  09844061806  
Fax    
Email  revive_cos@rediffmail.com  
 
Details of Contact Person
Scientific Query  
Name  BN Ingalagi 
Designation  Executive Director - NPD 
Affiliation  Sante Mernaud Pharmaceuticals  
Address  Sante Mernaud Pharmaceuticals Pvt.Ltd. BANGALORE-560058.

Bangalore
KARNATAKA
560058
India 
Phone  9886014528  
Fax    
Email  ingalagi@santemernaud.com  
 
Details of Contact Person
Public Query  
Name  Vikram Baburao 
Designation  Manager-Clinical operations 
Affiliation  ICBio Clinical Research Pvt. Ltd 
Address  ICBio Clinical Research Pvt. Ltd #16, ICBio Tower, Yelahanka Main Road, Chikkabetahalli, Vidyaranyapura, Bangalore - 560 097

Bangalore
KARNATAKA
560 097
India 
Phone  9900111993  
Fax    
Email  vikram.baburao@icbiocro.com  
 
Source of Monetary or Material Support  
Sante Mernaud Pharmaceuticals  
 
Primary Sponsor  
Name  Sante Mernaud Pharmaceuticals Pvt Ltd 
Address  Sante Mernaud Pharmaceuticals No.466, 12th’A’Cross, Peenya 4th Phase, Peenya Industrial Area, Peenya, Bangalore560 058  
Type of Sponsor  Pharmaceutical industry-Indian 
 
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 J Prasad   Revive Cosmetic Clinique  Revive Cosmetic Clinique #72, 2nd Road, Nandidurga Extn, Jayamahal Bangalore – 560 046. Tel: 080-32555055
Bangalore
KARNATAKA 		 09844061806

revive_cos@rediffmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Clinical IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L80-L99||Other disorders of the skin and subcutaneous tissue,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not Applicable  None  
Intervention  Tubby  Tubby nutririch lotion is an emollient for dry skin The lotion is to be applied gently all over the body to severely dry areas, in the morning & in the evening before retiring to bed for 1 month 
 
Inclusion Criteria  
Age From  6.00 Month(s)
Age To  12.00 Year(s)
Gender  Both 
Details  • Children between 6 months to 12 years of age
• Parents willing to provide written informed consent/assent
• Diagnosed as having dry skin with or without mild to moderate atopic tendency
 
 
ExclusionCriteria 
Details  • Patient has clinically infected atopic dermatitis at baseline.

• Patient with known hypersensitivity in general, to study drug or any excipients of the product
• Any dermatological condition other than atopic dermatitis that in the Investigators opinion may interfere with the evaluation of the patients atopic dermatitis
• Patients using non-sedating histamines least 7 days prior to the first dosing day or throughout the study.
• Severe Atopic Dermatitis
• History of other skin disorders, that could interfere with the evaluations
• Use of any topical treatment known or suspected to have an effect on atopic dermatitis within one week prior to the screen visit (except for calcineurin inhibitors, for which the washout is 2 weeks)
• Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study
• Use of any other investigational agent in the last 30 days
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
• Change from Baseline in the EASI (Eczema Area Severity Index) Score [All visits].
• Investigator global evaluation [Base line and Week 4]
• Change in Moisture content and trans-epidermal water loss from baseline [Base line and Week 4]
 		 Base line and Week 4
 
 
Secondary Outcome  
Outcome  TimePoints 
• Quality of life by using IDQOL and DFI, CDQOL [Base line and Week 4]
• Investigator/Patient LAR/patient evaluation (All visits) for Comedogenic, Photosensitivity and hypoallergenicity
• To monitor the Adverse events and concomitant medications in all visits 		 Base line and Week 4 
 
Target Sample Size   Total Sample Size="15"
Sample Size from India="15" 
Final Enrollment numbers achieved (Total)= "15"
Final Enrollment numbers achieved (India)="15" 
Phase of Trial   N/A 
Date of First Enrollment (India)   13/08/2012 
Date of Study Completion (India) 26/12/2012 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   It is a prospective clinical trial to evaluate the efficacy and safety of Tubby nutririch lotion for the treatment of dry skin with or without Atopic tendency in infants and children.
The objectives of the study are

Primary objectives:

To evaluate the efficacy of Tubby nutririch lotion in infants and children with dry skin. 

Secondary objectives:

To evaluate the safety of Tubby nutririch lotion in infants and children with dry skin.

During the screening visit & visit 1 (Day -3 to Day 1), insistent explanation to the patients and instructions will be done. Then handing over of patient consent form, patient information form to obtain written consent from the parents will be done. Then subject Id is given to the subject.

Baseline Assessments will be done using the EASI questionnaire. Skin assessments will be done for moisture content (skin hydration) and trans-epidermal water loss. Quality of life is assessed using The Infant’s Dermatitis Quality of Life Index (IDQOL) or CDQOL and Dermatitis Family Impact Questionnaire (DFI).Then the IP is dispensed and determine the next date of visit.

During Visit 2 ( Day 7 ± 1) and Visit 3 (Day 14 ± 1) the procedures that are done are recording of AEs, Concomitant Medications, Issue of diary card, Investigator/subject evaluation using questionnaire and Determine the next date of visit. EASI questionnaire assessment will be done.

During the Visit 4 (final visit-Day 28 ± 1) Assessments will be done using the EASI questionnaire. Assessments for skin moisture content and trans-epidermal water loss. Quality of life is assessed using The Infant’s Dermatitis Quality of Life Index (IDQOL), CDQOL and Dermatitis Family Impact Questionnaire (DFI) 
 
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