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CTRI Number  CTRI/2024/12/077728 [Registered on: 05/12/2024] Trial Registered Prospectively
Last Modified On: 02/12/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Cosmetics]  
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   Skin test on healthy human volunteers 
Scientific Title of Study   Evaluation of dermatological safety and hypo-allergenicity of investigational products by Human Repeat Insult Patch Test (HRIPT) on healthy human volunteers as per IS 4011:2018 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
RRS/CL/HRIPT/002/2024 Version: 01 dated: 16/10/2024   Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ashok Godavarthi 
Designation  CEO 
Affiliation  Radiant Research Services Pvt Ltd  
Address  Radiant Research Services Pvt Ltd Plot No:99/A,8th Main Road, 3rd Phase,Peenya Industrial Area, Bengaluru, Karnataka 560058.

Bangalore
KARNATAKA
560058
India 
Phone  09880999297  
Fax    
Email  surya.ashok@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ashok Godavarthi 
Designation  CEO 
Affiliation  Radiant Research Services Pvt Ltd  
Address  Radiant Research Services Pvt Ltd 1st Floor 3rd Phase, 5, 253/254/B, 11th Main Rd, Yeshwanthpur Suburb II Stage, Peenya, Bengaluru, Karnataka 560058

Bangalore
KARNATAKA
560058
India 
Phone  09880999297  
Fax    
Email  surya.ashok@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Ashok Godavarthi 
Designation  CEO 
Affiliation  Radiant Research Services Pvt Ltd  
Address  Radiant Research Services Pvt Ltd 1st Floor 3rd Phase, 5, 253/254/B, 11th Main Rd, Yeshwanthpur Suburb II Stage, Peenya, Bengaluru, Karnataka 560058.

Bangalore
KARNATAKA
560058
India 
Phone  09880999297  
Fax    
Email  surya.ashok@gmail.com  
 
Source of Monetary or Material Support  
SC JOHNSON & SON NIGERIA LTD 13/14 ABIMBOLA STREET, ISOLO LAGOS NIGERIA.  
 
Primary Sponsor  
Name  SC Johnson Son Nigeria Ltd  
Address  Isolo Industrial Estate, 13/14 Abimbola St, Isolo, Lagos 102214, Lagos, Nigeria  
Type of Sponsor  Other [[Cosmetic Industry]] 
 
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 Madan Mohan N T   Sri Venkateshwara Hospital,   Site No 1, SKY HEIGHTS, 2, Sarjapura- Attibele Road, Bangalore, Karnataka 562107.
Bangalore
KARNATAKA 		 8065733349

drmadan1969@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sri Venkateshwara Hospital Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Isotonic Saline  40µl of negative control (0.9% Isotonic Saline solution) was pipetted out on allotted Derma proof Aluminium Finn chamber prefixed to a scanpore tape. 
Intervention  Nixoderm Tube   40 µl of investigational product (without dilution) was applied on the precut filter paper placed inside the allotted Derma proof Aluminium Finn chamber prefixed to a scanpore tape. Patch was applied on upper arm or back. 
Comparator Agent  Sodium Lauryl Sulphate  40µl of positive control (Sodium Lauryl Sulphate, diluted to a concentration of 1% w/v) was pipetted out on allotted Derma proof Aluminium Finn chamberprefixed to a scanpore tape 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Voluntary men/women between 18 and 65 years.
2. Photo type III to V.
3. Having apparently healthy skin on test area
4. For whom the investigator considers that the compliance will be correct.
5. Cooperating, informed of the need and duration of the examinations and
ready to comply with protocol procedures.
6. Having signed a Consent Form.
7. Willingness to avoid intense UV exposure on test site (sun or artificial UV), during the course of the study.
8. Willingness to avoid excessive water contact (for example swimming) or
activity which causes excessive sweating (that is exercise, sauna…), during
the course of the study.
9. Should be able to read and write (in English, Hindi or local language).
10. Having valid proof of identity and age. 
 
ExclusionCriteria 
Details  1. Pregnant/nursing mothers
2. Scars, excessive terminal hair or tattoo on the studied area.
3. Henna tattoo anywhere on the body (in case of studies involving hair
dyes).
4. Dermatological infection/pathology on the level of studied area.
5. Hypersensitivity, allergy antecedent (to any cosmetic product, raw
material or hair dye).
6. Any clinically significant systemic or cutaneous disease, which may
interfere with study treatment or procedures.
7. Chronic illness which may influence the outcome of the study.
8. Subjects on any medical treatment either systemic or topical which may
interfere with the performance of the study treatment (presently or in
the past 1 month).
9. Subject in an exclusion period or participating in another food, cosmetic
or therapeutic trial. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. To determine the irritation & or sensitization potential of a test material.
2. In support of sensitive skin claims &supporting evidence for hypoallergenicity claims after repeated application under occlusive or
semi occlusive patches to the skin of humansubjects. 		 Day 1 to Day 40
 
 
Secondary Outcome  
Outcome  TimePoints 
Incidence & rate of adverse events.  Day 1 to Day 40 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
Final Enrollment numbers achieved (Total)= "200"
Final Enrollment numbers achieved (India)="200" 
Phase of Trial   N/A 
Date of First Enrollment (India)   13/12/2024 
Date of Study Completion (India) 21/02/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 will be conducted over a period of 40 days for each subject, there is first induction phase where patches will be applied on thrice a week basis for three weeks, a two-week washout period is called rest phase involves no application of any patch in order to develop sensitization to the test product, immediately followed by challenge phase and then observation for 24hrs, 48 hrs and 72 hrs after patch removal.  
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