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CTRI Number  CTRI/2024/10/075033 [Registered on: 10/10/2024] Trial Registered Prospectively
Last Modified On: 10/10/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Primary Irritation Patch Testing]  
Study Design  Other 
Public Title of Study   To Check Dermatological Safety of Test Products by 24 Hours Patch Test on Adult Healthy Human Subjects. 
Scientific Title of Study   Evaluation of Dermatological Safety of Test Products by 24 Hours Patch Test under Complete Occlusion or Semi Occlusion or Open Patch on Adult Healthy Human Subjects. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NB240048-BM, 1.0, 26 Jul 24  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nayan Patel 
Designation  Principal Investigator 
Affiliation  NovoBliss Research Private Limited 
Address  Office-A - 206, 2nd Floor, Shaligram Lakeview Business Complex, Near Vaishnodevi Circle, Khoraj, Gandhinagar, Gujarat - India Gandhinagar GUJARAT 382421 India

Gandhinagar
GUJARAT
382421
India 
Phone  9909013286  
Fax    
Email  dr.nayan@novobliss.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Nayan Patel 
Designation  Principal Investigator 
Affiliation  NovoBliss Research Private Limited 
Address  Office-A - 206, 2nd Floor, Shaligram Lakeview Business Complex, Near Vaishnodevi Circle, Khoraj, Gandhinagar, Gujarat - India Gandhinagar GUJARAT 382421 India


GUJARAT
382421
India 
Phone  9909013286  
Fax    
Email  dr.nayan@novobliss.in  
 
Details of Contact Person
Public Query  
Name  Dr. Maheshvari Patel 
Designation  Director Operations and Strategic Management 
Affiliation  NovoBliss Research private Limited 
Address  Office-A - 206, 2nd Floor, Shaligram Lakeview Business Complex, Near Vaishnodevi Circle, Khoraj, Gandhinagar, Gujarat - India Gandhinagar GUJARAT 382421 India

Gandhinagar
GUJARAT
382421
India 
Phone  9909013236  
Fax    
Email  maheshvari@novobliss.in  
 
Source of Monetary or Material Support  
Blossom Microbiotics LLC 4111-E Rose Lake Dr #6005, Charlotte, North Carolina  
 
Primary Sponsor  
Name  Blossom Microbiotics LLC  
Address  4111-E Rose Lake Dr #6005, Charlotte, North Carolina  
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
Nil  NA 
 
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 Pvt. Limited  NovoBliss Research Pvt. Ltd. Office# A - 206, 2nd Floor, Shaligram Lakeview Business Complex, Nr. Vaishnodevi Circle, Khoraj, Gandhinagar – 382421, Gujarat - India
Gandhinagar
GUJARAT 		 9909013286

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  Normal Skin 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NA  NA 
Intervention  SaaTwae Bio-Natural Moisturizing Cream  Dose: 0.04gm Route of administration: Topical Products will be evaluated through the complete occlusion or open application for 24 hours. At 24 hours post-application, patches will be removed and skin will be evaluated for irritation reactions at 30 mins,24 hours (Day 1) post patch removal and 168 hours (Day 7) post-patch removal (if needed). 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1) Age: 18-65 years (both inclusive) at the time of consent.
2) Sex: Males and non-pregnant/non-lactating females (preferably equal number of males and females).
3) Subject with normal Fitzpatrick skin type III to V (Human skin colour determination scale).
4) Females of childbearing potential must have a self-reported negative pregnancy test.
5) Subject who do not have any previous history of adverse skin conditions and are not under any medication likely to interfere with the results.
6) Subject is in good general health as determined by the Investigator on the basis of medical history.
7) Subjects is willing to maintain the test patches in designated positions for 24 Hours.
8) Subject is willing and able to follow the study directions, to participate in the study, returning for all specified visits.
9) Subject must be able to understand and provide written informed consent to participate in the study.
10) Subject is willing to refrain from vigorous physical exercise during the study period and follow all the instruction given.
 
 
ExclusionCriteria 
Details  1) Subject having skin irritation, blemishes, excessive hair, moles, pigmentation, pimples, marks (e.g. tattoos (within the previous 3 months), 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) Medication which may affect skin response and/or past medical history.
3) Subject having history of diabetes
4) Subject have history of mastectomy for cancer involving removal of lymph nodes within the past year, or treatment of any type of cancer within the last 6 months.
5) Subject suffering from any active clinically significant skin diseases which may contraindicate.
6) Subject having history of any skin diseases including eczema, atopic dermatitis or active cancer.
7) Participation in any patch test for irritation or sensitization within the last four weeks.
8) Subject having history of asthma or COPD (Chronic obstructive pulmonary disease).
9) 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)
10) Topical drugs used at application site.
11) Subject with Self-reported Immunological disorders such as HIV positive, AIDS and/or systemic lupus erythematous.
12) Individual who has a medical condition or is taking or has taken a medication which, in the Investigator’s judgment, makes the subject ineligible or places the subject at undue risk.
13) Subject with known allergy or sensitization to medical adhesives, bandages.
14) Participation in other patch study simultaneously.
 
 
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 adult human
subjects and adequate representation of varied
skin types (Oily, Dry, Normal and Combination) 		 Irritation Scoring at T30 mins and 24 hours post
patch removal. Scoring can be done at T168
hours post-patch removal if needed. 
 
Secondary Outcome  
Outcome  TimePoints 
Safety of the skin  At T30 mins and 24 hours post patch removal.
Scoring can be done at T168 hours post-patch
removal if required. 
 
Target Sample Size   Total Sample Size="26"
Sample Size from India="26" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   21/10/2024 
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="0"
Days="10" 
Recruitment Status of Trial (Global)   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 single-center, evaluator blinded study in healthy human subjects. single 24-hour application of sponsors provided test product along with positive and negative control will be kept in contact with the skin if subject under icclllusion or semi occlusion or open patch for at least 24 hours (± 2 hours). safety will be assed through the study by monitoring of adverse event
A sufficient number 26 subject will be enrolled to get 24 completed the study. There are total three visits in this study and are optional visit pre-screening visit : Lactic Acid Stinging test& Modified Dr baumenn’s skin type questionnaire.
Visit 01: Screening, Enrollment, and Patch Application (Day 01)
Visit 02: Patch Removal After 24 hours of Application & 30 ± 5 min irritation scoring upon patch removal
Visit 03: 24 (± 2 hour) irritation scoring (Day 03)
visit 04: subject will be contacted telephonically on Day 08 for any signs of irritation at patch application site.
Follow-up visit for reactions if any to confirm recovery (optional deemed necessary)
Irritation scoring at 168 ± 2 hours post-patch removal (Day 09)
 
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