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CTRI Number  CTRI/2024/07/070558 [Registered on: 13/07/2024] Trial Registered Prospectively
Last Modified On: 09/07/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [safety study]  
Study Design  Single Arm Study 
Public Title of Study   A clinical study to assess the safety, in-use tolerability of test product in healthy adult subjects with dry and sensitive skin. 
Scientific Title of Study   Open-Label, Interventional, Prospective, Safety, In-Use Tolerability Study of Test Product “No Rays, Thanks Mineral Sunscreen” in healthy adult subjects with dry and sensitive skin. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NB240031-KE Version 1.0 26 Jun 24  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nayan Patel 
Designation  Principal Investigator-Medical Director 
Affiliation  NovoBliss Research Private Limited 
Address  NovoBliss Research Pvt. Ltd. Office# A - 206, 2nd Floor, Shaligram Lakeview Business Complex, Nr. Vaishnodevi Circle, Khoraj, Gandhinagar – 382421, Gujarat – 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-Medical Director 
Affiliation  NovoBliss Research Private Limited 
Address  NovoBliss Research Pvt. Ltd. Office# A - 206, 2nd Floor, Shaligram Lakeview Business Complex, Nr. Vaishnodevi Circle, Khoraj, Gandhinagar – 382421, Gujarat – India


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

Gandhinagar
GUJARAT
382421
India 
Phone  9909013236  
Fax    
Email  maheshvari@novobliss.in  
 
Source of Monetary or Material Support  
Kayura Effect LLP 1108, 11th Floor, Salister Building, Rajpath Rangoli Road, SG Highway, Ahmedabad - 380054 Gujarat- India 
 
Primary Sponsor  
Name  Kayura Effect LLP 
Address  1108, 11th Floor, Salister Building, Rajpath Rangoli Road, SG Highway, Ahmedabad - 380054 Gujarat- India  
Type of Sponsor  Pharmaceutical industry-Indian 
 
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  Clinical trial department 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  Dry and Sensitive skin 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NA 
Intervention  No Rays Thanks Mineral Sunscreen  Test product name: No Rays Thanks Mineral Sunscreen Marketed By |Manufactured By: Kayura Effect LLP dose: as required dosage form: semi solid Mode of Usage: Wash your face with standard facewash and apply a pea size amount on the face in the morning. Frequency: Once a day in Morning Route of Administration: Topical  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  1)Age: 18 to 55 years (both inclusive) at the time of consent.
2)Sex: Healthy male and non-pregnant/non-lactating females. (Preferably equal ratio of males and females)
3)Females of childbearing potential must have a self-reported negative pregnancy test.
4)Subject are generally in good health.
5)Subject with dry and sensitive skins. (As per the dermatological evaluation).
6)Subject is able to remain on stable doses of contraceptive or replacement hormonal therapy, including no therapy, 6 weeks prior to and for the duration of the study.
7)If the subject is of childbearing potential, is practicing and agrees to maintain an established method of birth control (IUD, hormonal implant device/injection, regular use of birth control pills or patch, diaphragm, condoms with spermicide or sponge with spermicidal jelly, cream or foam, partner vasectomy or abstinence). Females will be considered as non-childbearing potential if they are surgically sterile, have been post-menopausal for at least 1 year or have had a tubal ligation.
8)Subjects are willing to give written informed consent and are willing to come for regular follow up.
9)Subjects who commit not to use medicated skincare products other than the test product for the entire duration of the study.
10)Subject who have not participated in a similar investigation in the past three months.
11)Willing to use test product throughout the study period.
 
 
ExclusionCriteria 
Details  1)History of any dermatological condition of the skin disease.
2)Subject with present condition of allergic response to any cosmetic product.
3)Subjects under chronic medication (e.g. aspirin-based products, anti-inflammatories, anti-histamines, corticotherapy etc.) that might influence the outcome of the study.
4)History of alcohol or drug addiction.
5)The subject has clinically significant skin disease, which may contraindicate participation, including psoriasis, eczema, skin cancer or other skin pathology.
6)Subjects having skin infections like bacterial, fungal, viral infections.
7)The subject has skin irritation, open wounds, cuts, abrasions, irritation symptoms or any dermatological condition on the face that can interfere with the reading.
8)Be wearing any facial makeup, including false eyelashes, on the day of the study visit.
9)Subjects having hypersensitive skin.
10)Subjects using other marketed sun screen products during the study period.
11)Any other condition which could warrant exclusion from the study, as per the dermatologist’s/investigator’s discretion.
12)Pregnant or breastfeeding or planning to become pregnant during the study period.
13)History of chronic illness which may influence the cutaneous state.
14)Subjects participating in other similar cosmetics, devices or therapeutic trials or skincare products within the last four weeks.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To assess the safety of the test product in terms of
1.Change in local intolerance assessment for irritation, dryness, Oedema after usage of test product on Day 01 at T15 mins and on Day 15 by the dermatologist.
2. Change in local intolerance assessment for irritation, dryness, Oedema after usage of test product on Day 01 at T15 mins and on Day 15 by the Patient Global Assessment Scale.
 		 on Day 1 after usage of test product at T20 mins and Day 15 
 
Secondary Outcome  
Outcome  TimePoints 
1.To assess the safety of the test product in terms of change in organoleptic parameters through the subject product perception from baseline before usage of test product on Day 01 and after usage of test product on Day 01 at T20 mins and on Day 15 by using Likert scoring scale.   baseline on Day 1 and after usage of test product on Day 1 at T20 mins and Day 15  
 
Target Sample Size   Total Sample Size="27"
Sample Size from India="27" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   25/07/2024 
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="15" 
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 open-label, interventional, prospective, safety in-use tolerability study of test product “No Rays, Thanks Mineral Sunscreen” in healthy adult human subjects with dry and sensitive skin. A total of up to 27 subjects will be enrolled to complete 25 subjects the study.

Visit 01 (Day 01): Screening, Enrolment, Baseline Evaluation, on site product usage, Post usage evaluation at T15 mins.

Visit 02 (Day 15): Evaluations, End of Study.

 
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