| CTRI Number |
CTRI/2022/12/048266 [Registered on: 19/12/2022] Trial Registered Prospectively |
| Last Modified On: |
07/03/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmetics - Lipsticks and Kajal] |
| Study Design |
Other |
|
Public Title of Study
|
Assessment of Skin 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 | Semi Occlusion |Open Patch on Adult Healthy Human Subjects |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NBSP22-PIPT-0032-RC, Version No. 01 Dated 28Sep22 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nayan Patel |
| Designation |
Medical Director |
| 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 |
| Phone |
91-9909013286 |
| Fax |
|
| Email |
dr.nayan@novobliss.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nayan Patel |
| Designation |
Medical Director |
| Affiliation |
NovoBliss Research Private Limited |
| Address |
Office-A - 206, 2nd Floor, Shaligram Lakeview Business Complex, Near Vaishnodevi Circle, Khoraj, Gandhinagar, Gujarat - India
GUJARAT
382421
India |
| Phone |
91-9909013286 |
| Fax |
|
| Email |
dr.nayan@novobliss.in |
|
Details of Contact Person
Public Query
|
| Name |
Maheshvari Patel |
| Designation |
Director - Operations |
| 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 |
| Phone |
91-9909013236 |
| Fax |
|
| Email |
maheshvari@novobliss.in |
|
|
Source of Monetary or Material Support
|
| Renee Cosmetics Private Limited
4, OM Complex, 2nd Floor,
Swastik Char Rasta, C.G.Road,
Ahmedabad, Gujarat, India - 380009
|
|
|
Primary Sponsor
|
| Name |
Renee Cosmetics Private Limited |
| Address |
4, OM Complex, 2nd Floor,
Swastik Char Rasta, C.G.Road,
Ahmedabad, Gujarat, India - 380009 |
| Type of Sponsor |
Other [FMCG ] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| None |
Not Applicable |
|
|
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 Shopping Complex,
Near Vaishnodevi Circle, Khoraj,
Gandhinagar – 382421, 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 |
Oily, Dry, Normal and Combination Skin |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Negative Control - Sodium chloride (Isotonic Saline Solution) Injection IP 0.9 % w/v |
A 0.04 mL of test sample dispensed onto the center of an appropriately sized filter paper will be placed in the Finn chambers prefixed to a micropore tape |
| Comparator Agent |
Positive Control - Sodium Lauryl Sulphate (SLS) analytical grade 3% w/v |
A 0.04 mL of test sample dispensed onto the center of an appropriately sized filter paper will be placed in the Finn chambers prefixed to a micropore tape |
| Intervention |
Princess By Renee ICE Cream Lip Gloss |
Products will be evaluated through the complete occlusion 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) |
| Intervention |
Princess By Renee Snowball Lip Balm |
Products will be evaluated through the complete occlusion for 24 hours. At 24hours 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 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)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 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) |
Irritation Scoring at 30 mins and 24 hours (Day 1) post
patch removal. Scoring can be done at 168 hours (Day 7) post-patch removal if needed. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The safety of the skin will be assessed through the occurrence of Adverse Events. |
At 30 mins and 24 hours (Day 1) post patch removal. Scoring can be done at 168 hours (Day 7) post-patch removal if needed. |
|
|
Target Sample Size
|
Total Sample Size="26"
Sample Size from India="26"
Final Enrollment numbers achieved (Total)= "25"
Final Enrollment numbers achieved (India)="25" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
26/12/2022 |
| Date of Study Completion (India) |
29/12/2022 |
| 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
|
Not Applicable |
|
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 females Score 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 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’. |