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CTRI Number  CTRI/2023/11/059923 [Registered on: 16/11/2023] Trial Registered Prospectively
Last Modified On: 19/12/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Cosmetics]  
Study Design  Other 
Public Title of Study   Primary Irritation Patch Test on Normal skin under complete occlusion. 
Scientific Title of Study   Evaluation of Dermatological Safety of Test Products by 24 Hours Patch Test under Complete Occlusion on Adult Healthy Human Participants with Normal Skin. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
C3B03444-TLS-B, Version: 01, Dated 26 Oct 23  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Bhagirath Patel 
Designation  Principal Investigator 
Affiliation  Cliantha Research  
Address  Consumer Research Department, Corporate House 17, Sigma 1 Corporate House, BH. Rajpath Club, Off. Sindhubhavan Road, Nr. Mann Party Plot Cross Road, Bodakdev, Ahmedabad-380054-India

Ahmadabad
GUJARAT
380054
India 
Phone  9825618138  
Fax    
Email  bhagirathrpatel1818@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Mr Satyendra Kumar 
Designation  Sr. Manager- Clinical Research 
Affiliation  Transformative Learning Solutions Pvt Ltd.  
Address  301B, 302-304, 3rd floor, Veritas Business Suite, Sec-53, Gurgaon, Haryana 122002, Gurgaon HARYANA 122002 India

Gurgaon
HARYANA
122002
India 
Phone  9891253516  
Fax    
Email  satyendra.kumar@transformative.in  
 
Details of Contact Person
Public Query  
Name  Dr Simran Sethi 
Designation  Director-Consumer Research  
Affiliation  Cliantha Research  
Address  Consumer Research Department, Corporate House 17, Sigma 1 Corporate House, BH. Rajpath Club, Off. Sindhubhavan Road, Nr. Mann Party Plot Cross Road, Bodakdev, Ahmedabad-380054-India

Ahmadabad
GUJARAT
380054
India 
Phone  9825784942  
Fax    
Email  ssethi@cliantha.com  
 
Source of Monetary or Material Support  
Cliantha Research, Consumer Research Department, Corporate House 17, Sigma 1 Corporate House, BH. Rajpath Club, Off. Sindhubhavan Road, Nr. Mann Party Plot Cross Road, Bodakdev, Ahmedabad-380054-India 
Transformative Learning Solutions Pvt Ltd. 301B, 302-304, 3rd floor, Veritas Business Suite, Sec-53, Gurgaon, Haryana 122002, Gurgaon HARYANA 122002 India 
 
Primary Sponsor  
Name  Transformative Learning Solutions Pvt Ltd. 
Address  301B, 302-304, 3rd floor, Veritas Business Suite, Sec-53, Gurgaon, Haryana – 122002 
Type of Sponsor  Other [FMCG - Fast Moving Consumer Goods] 
 
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 Bhagirath Patel  Cliantha Research   Consumer Research Department, Corporate House 17, Sigma 1 Corporate House, BH. Rajpath Club, Off. Sindhubhavan Road, Nr. Mann Party Plot Cross Road, Bodakdev, Ahmedabad-380054. Ahmedabad, Gujarat.
Ahmadabad
GUJARAT 		 9825618138

bhagirathrpatel1818@gmail.com 
 
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  18 to 65 years healthy adult male & female with normal skin of varied Skin types (Oily, Dry, Normal and Combination). 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Balaayah Black Gram Body Booster Romance  Neat, 0.04mg, single dose, topical application, 24 hr 
Intervention  Balaayah Black Gram Body Booster Seduction  Neat, 0.04mg, single dose, topical application, 24 hr 
Intervention  Balaayah Black Gram Body Booster Serenity  Neat, 0.04mg, single dose, topical application, 24 hr 
Intervention  Balaayah Black Gram Body Booster Sunshine  Neat, 0.04mg, single dose, topical application, 24 hr 
Intervention  Balaayah Black Gram Body Booster Tea-Garden  Neat, 0.04mg, single dose, topical application, 24 hr 
Intervention  Kesaradi Daily Glow  Neat, 0.04mg, single dose, topical application, 24 hr 
Comparator Agent  Negative Control  Neat, 0.9gm of Sodium Chloride in 100ml of distilled water (0.9% w/v) , 0.04 mg, single dose, topical application, 24 hr 
Intervention  Paraania Oil  Neat, 0.04mg, single dose, topical application, 24 hr 
Comparator Agent  Positive Control  1 gm of SLS in 100 mL of distilled water (1 % w/v) , 0.04 mg, single dose, topical application, 24 hr 
Intervention  Sagging Skin Body Serum  Neat, 0.04mg, single dose, topical application, 24 hr 
Intervention  Skin Firming Serum  Neat, 0.04mg, single dose, topical application, 24 hr 
Intervention  Trahnna Heart-Leaved Moonseed Protectionist Body Soother  Neat, 0.04mg, single dose, topical application, 24 hr 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1) Males and non-pregnant/non-lactating females (preferably equal numbers of males and females) between age group of 18 to 65 years (both inclusive) at the time of consent.
2) Participants with normal Fitzpatrick skin type III to V. (Human skin colour determination scale).
3) Females of childbearing potential must have a negative urine pregnancy test performed on Day 01 prior to patch application.
4) Participants who do not have any previous history of adverse skin conditions and are not under any medication are likely to interfere with the results.
5) Participants are in good general health as determined by the Investigator on the basis of medical history.
6) Participants willing to maintain the test patches in designated positions for 24 Hours and refrain from vigorous physical exercise during the study period.
7) Participants willing and able to follow the study directions to participate in the study, return for all specified visits.
8) Participants must be able to understand and provide written informed consent to participate in the study.
9) Participants having valid proof of identity and age. 
 
ExclusionCriteria 
Details  1) Participants having skin irritation, blemishes, excessive hair, moles, pigmentation, pimples, marks (e.g. tattoos, scars, sunburn), open wounds, cuts, abrasions, irritation symptoms or any dermatological condition on the test site(s) i.e. back that can interfere with the reading.
2) Participant with history of asthma or COPD (Chronic obstructive pulmonary
disease), diabetes and mastectomy for cancer involving removal of lymph nodes
within the past year, or treatment of any type of cancer within the last 6 months.
3) Participant suffering from any active clinically significant skin diseases which
may affect the study results.
4) Participant having history of any skin diseases including eczema, atopic dermatitis.
5) Participation in any patch test for irritation or sensitization within the last four weeks.
6) Participants taking part in another study liable to interfere with the results of this study.
7) Participants with self-reported Immunological disorders such as HIV positive, AIDS and systemic lupus erythematous.
8) Participants with a medical condition or are taking or have taken a medication which, in the Investigator’s judgment, makes the Participant ineligible or places the Participant at undue risk.
9) Participant with known allergy or sensitization to medical adhesives, bandages.
10) Use of any:
i. Prescribed or over-the-counter (OTC) anti-inflammatory drug within five (5) days prior to application.
ii. Antihistamine medication or immunosuppressive drugs within seven (7) days prior to first patch application.
iii. Systemic or topical corticosteroids at patch site within four (4) weeks of test product application (steroidal nose drops and/or eye drops are permitted)
iv. Topical drugs used at application site 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate the dermatological safety of the test products by 24 Hours Patch Test Under Complete Occlusion on healthy human participants with normal skin.  30 minutes of patch removal (Day 02), 24 hours (Day 03) and 168 hours (Day 09) 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="26"
Sample Size from India="26" 
Final Enrollment numbers achieved (Total)= "24"
Final Enrollment numbers achieved (India)="24" 
Phase of Trial   N/A 
Date of First Enrollment (India)   29/11/2023 
Date of Study Completion (India) 29/11/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="0"
Days="9" 
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  

The study consists of single application of sample on the upper back of human participants, under occlusive patch for the duration of 24 hour of exposure. After removal of patches post 24 hr. The assessment of skin reaction needs to be evaluated subjectively using the Draize Scale 24hour removal of patches. Follow up reactions will be done one week thereafter to confirm recovery

 
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