| CTRI Number |
CTRI/2022/09/045784 [Registered on: 22/09/2022] Trial Registered Prospectively |
| Last Modified On: |
02/12/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmetics and PersonalCare Products] |
| Study Design |
Other |
|
Public Title of Study
|
A clinical study to assess skin safety in terms of skin redness, swelling, dryness due to application
the test products by 24 hours patch test under complete closed application on adult healthy human
subjects |
|
Scientific Title of Study
|
Evaluation of Dermatological Safety of Test Products by 24 Hours Patch Test under Complete
Occlusion on Adult Healthy Human Subjects |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NBSP210001-BB-B Version No. 01 (Final), 25 Oct 21 |
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 |
Office- A - 206, 2nd Floor, Shaligram Lakeview, Near Vaishnodevi
Circle, Khoraj, Gandhinagar, Gujarat, India
Gandhinagar
GUJARAT
382 421
India |
| Phone |
91-9909013286 |
| 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 |
Office- A - 206, 2nd Floor, Shaligram Lakeview, Near Vaishnodevi
Circle, Khoraj, Gandhinagar, Gujarat, India
Gandhinagar
GUJARAT
382 421
India |
| Phone |
91-9909013286 |
| 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 |
Office- A - 206, 2nd Floor, Shaligram Lakeview, Near Vaishnodevi
Circle, Khoraj, Gandhinagar, Gujarat, India
Gandhinagar
GUJARAT
382421
India |
| Phone |
91-9909013236 |
| Fax |
|
| Email |
maheshvari@novobliss.in |
|
|
Source of Monetary or Material Support
|
| JSR Healthcare Private Limited (Bare Body Plus),
ZED House,
16, Navyug Society,
Ambawadi, Ahmedabad - 380006,
Behind Elements Building
Gujarat, India
|
|
|
Primary Sponsor
|
| Name |
JSR Healthcare Private Limited Bare Body Plus |
| Address |
JSR Healthcare Private Limited (Bare Body Plus),
ZED House,
16, Navyug Society,
Ambawadi, Ahmedabad - 380006,
Behind Elements Building
Gujarat, India
|
| Type of Sponsor |
Other [Cosmetics and FMCG] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Not Applicable |
None |
|
|
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 Private Limited |
Office- A - 206, 2nd Floor, Shaligram Lakeview, Near Vaishnodevi
Circle, Khoraj, Gandhinagar, Gujarat, India
Department-Clinical Trials
Gandhinagar
GUJARAT |
91-9909013286
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Subjects with varied skin types (Oily, Dry,
Normal and Combination) |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bum Cream |
Dose - A 0.04 g of test produce(piece of product) dispensed
onto the center of an appropriately sized filter paper
placed in the designated IQ/Finn chambers prefixed to a
micropore tape.
Frequency - 24-hours single application
Route of Administration - Topical |
| Intervention |
Face Glow Cream |
Dose - A 0.04 g of test produce(piece of product) dispensed onto the center of an appropriately sized filter paper placed in the designated IQ/Finn chambers prefixed to a micropore tape. Frequency - 24-hours single application Route of Administration - Topical |
| Intervention |
Neck Back Cream |
Dose - A 0.04 g of test produce(piece of product) dispensed onto the center of an appropriately sized filter paper placed in the designated IQ/Finn chambers prefixed to a micropore tape. Frequency - 24-hours single application Route of Administration - Topical |
| Comparator Agent |
Negative Control - 0.9% w/v
Normal Saline Solution |
Dose - A 0.04 mL of test
solution dispensed onto the
center of an appropriately sized
filter paper placed in the
designated IQ/Finn chambers
prefixed to a micropore tape.
Frequency - 24-hours single
application Route of
Administration - Topical |
| Comparator Agent |
Positive Control - 1% w/v
Sodium Lauryl Sulphate
Solution |
Dose - A 0.04 mL of test
solution dispensed onto the
center of an appropriately sized
filter paper placed in the
designated IQ/Finn chambers
prefixed to a micropore tape.
Frequency - 24-hours single
application Route of
Administration - Topical |
| Intervention |
Underarm Cream |
Dose - A 0.04 g of test produce(piece of product) dispensed onto the center of an appropriately sized filter paper placed in the designated IQ/Finn chambers prefixed to a micropore tape. Frequency - 24-hours single application Route of Administration - Topical |
|
|
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 negative urine pregnancy test performed on Day 01 prior to patch application.
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. The subject is in good general health as determined by the Investigator on the basis of medical history.
7. Subjects are 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. The 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 instructions 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) |
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) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Safety of the skin |
Irritation Scoring at 30 mins and 24 hours post
patch removal. Scoring can be done at 168
hours post-patch removal if needed. |
|
|
Target Sample Size
|
Total Sample Size="26"
Sample Size from India="26"
Final Enrollment numbers achieved (Total)= "26"
Final Enrollment numbers achieved (India)="26" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
26/09/2022 |
| Date of Study Completion (India) |
14/10/2022 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is single-centre, evaluator-blinded study in healthy adult human subjects. Single 24-hour application of sponsor(s) provided test products along with positive and negative controls will be kept in contact with the skin of subjects under occlusion for at least 24 hours (+ 2 hours). Study can be conducted in multiple groups. Safety will be assessed throughout the study by monitoring of adverse events. Subject’s back i.e. between the scapula and waist will be utilised as application sites. Application sites will be evaluated for scoring the reaction, namely, erythema, dryness, and wrinkles on a 0-4 point scale separately for each parameter and oedema on another 0-4 points scale as per the Draize Scale after 30+5 minutes of patch removal, 24±2 hours and 168±2 hours after patch removal.26 subjects in the age group of 18 to 65 years with varied skin types (Oily, Dry, Normal and Combination, preferably equal ratio) will be selected according to inclusion and exclusion criteria in the study to complete the required numbers i.e. 24 subjects at the end of the study. Preferably with an equal number of males and non-pregnant/non-lactating femalesScore the reaction, namely, erythema, dryness, wrinkles on a 0-4 point scale separately for each parameter and oedema on another 0-4 points scale as per the Draize Scale. Four parameters namely erythema, dryness, wrinkles and oedema will be scored separately on the irritation scoring sheet, however, the highest score of erythema, dryness and wrinkles will be taken for calculation of Mean Irritation Score (MIS). Mean Score for Irritation = Total score (highest score from Erythema, dryness, wrinkles + Oedema) for each sample / Total no. of Subjects.The Evaluator/Scorer will be blinded to test product assignments and any previous scores. All reasonable attempts will be made to ensure that the same individual will do scoring of all reactions to the test products during the course of the study. If the patch is reinforced with tape, any observed skin irritation that is associated with the tape should be reported separately from that of the patch application area. The combined mean scores and standard deviation of the 24 subjects will be calculated. a) Positive controls i.e. 1% w/v SLS must give a combined means score of >2.0, 3% w/v SLS must give a combined mean score of greater than 3.0 and Negative control must give a combined mean score of <2. If positive control 1% w/v SLS and 3% w/v SLS give a combined means score less than 2.0 and 3.0 respectively and/ or negative control give a combined mean score more than 2.0, then the test need to be repeated on another newly recruited volunteer’s. b) A combined mean score of up to 2.0/8.0 will mean that product is ‘Non-Irritant’. c) Usage of cosmetic product with a score up to 4.0/8.0 which is ‘Mildly Irritating’ may be reviewed by manufacturer for safety of the formulation. d) No cosmetic product should be marketed which has an irritation score above 4.0/8.0. This product should be considered as an ‘Irritant’. |