| CTRI Number |
CTRI/2020/02/023227 [Registered on: 10/02/2020] Trial Registered Prospectively |
| Last Modified On: |
06/05/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Safety Study] |
| Study Design |
Other |
|
Public Title of Study
|
Primary Irritation Patch test on Humans with Sensitive Skin |
|
Scientific Title of Study
|
Evaluation of dermatological safety of investigational products by primary irritation patch test on healthy human volunteers with sensitive skin |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| KLS19-ITC-279 Version: 00, Dated 16 Jan 20 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nayan Patel |
| Designation |
Principal Investigator |
| Affiliation |
Cliantha Research |
| Address |
Consumer Research Department,
Garden View Corporate House No 7,
Opp Auda Garden,
Bodakdev, Ahmedabad 380054, India
Phone 917966219500
Fax 917966219549
Ahmadabad
GUJARAT
380054
India |
| Phone |
9909013286 |
| Fax |
07966219549 |
| Email |
nkpatel@cliantha.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nayan Patel |
| Designation |
Principal Investigator |
| Affiliation |
Cliantha Research |
| Address |
Consumer Research Department,
Garden View Corporate House No 7,
Opp Auda Garden,
Bodakdev, Ahmedabad 380054, India
Phone 917966219500
Fax 917966219549
GUJARAT
380054
India |
| Phone |
9909013286 |
| Fax |
07966219549 |
| Email |
nkpatel@cliantha.com |
|
Details of Contact Person
Public Query
|
| Name |
Ms Maheshvari Patel |
| Designation |
Associate Director - Consumer Research |
| Affiliation |
Cliantha Research |
| Address |
Consumer Research Department,
Garden View Corporate House No 7,
Opp Auda Garden,
Bodakdev, Ahmedabad 380054, India
Phone 917966219500
Fax 917966219549
Ahmadabad
GUJARAT
380054
India |
| Phone |
9909013236 |
| Fax |
07966219549 |
| Email |
mnpatel@cliantha.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
ITC Life Sciences Technology Centre |
| Address |
Peenya Industrial area,
I Phase, Peenya
Bangalore- 560058
Karnataka, India |
| Type of Sponsor |
Other [FMCG] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Not Applicable |
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 |
Cliantha Research |
Consumer Research Department,
Garden View Corporate House No. 7,
Opp. Auda Garden,
Bodakdev, Ahmedabad 380054, India
Phone 917966219500
Fax 91 7966219549
Ahmadabad
GUJARAT |
9909013286
07966219549
nkpatel@cliantha.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| OM Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
18 to 65 years adult male & female of varied Skin types |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1. Feminine Intimate Hygiene Wash (Batch no. FTB-PC)
2. Feminine Intimate Hygiene Wash (Batch no. FTB-FV)
3. Feminine Intimate Hygiene Wash (Batch no. FTB-FVF)
4. Feminine Intimate Hygiene Wash (Batch no. 114-70,50 CW4)
5. Feminine Intimate Hygiene Wash (Batch no. 114-67,50 CW4)
6. Body Wash (Batch no. 121-16)
7. Body Wash (Batch no. 121-15 )
8. Body Wash (Batch no. KBW#127-32)
9. Body Wash (Batch no. KBW#127-33 )
10. Leave-On (Batch no. B002 GA )
11. Leave-On (Batch no. B001 GA )
12. Leave-On (Batch no. 11269)
13. Leave-On (Batch no. APG) |
1. 8% w/w in distilled water
2. 8% w/w in distilled water
3. 8% w/w in distilled water
4. 8% w/w in distilled water
5. 8% w/w in distilled water
6. 8% w/w in distilled water
7. 8% w/w in distilled water
8. 8% w/w in distilled water
9. 8% w/w in distilled water
10. No Dilution
11. No Dilution
12. No Dilution
13. No Dilution |
| Comparator Agent |
1. Positive Control (Cliantha code: BB)
2. Negative Control (Cliantha code: CC)
3. Negative Control (Cliantha code: CC) |
1. Sodium Lauryl Sulphate (SLS) analytical grade 1 % w/v
2. Sodium Lauryl Sulphate (SLS) analytical grade 3 % w/v
3. Sodium chloride (Normal Saline Solution) Injection IP 0.9 % w/v |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthy male and female subjects in the age group of 18-65 years (both age inclusive).
2. Subjects with Fitzpatrick skin type III to V.
3. Subjects with good general health as determined by the Investigator on the basis of medical history.
4. Subjects who score greater than 30 for section 2 sensitive vs resistant skin in Dr. Baumanns questionnaire.
5. Subject who identified to have skin basis Dermatologists assessment of skin with fine texture and closeness of blood vessels to the surface.
6. Subjects willing to give a voluntary written informed consent.
7. Subjects willing to maintain the test patches in designated positions for 24 Hours.
8. Subjects having not participated in a similar investigation in the past eight weeks.
9. Subjects willing to come for regular follow up visits.
10. Subjects ready to follow instructions during the study period.
11. Subjects without any open wounds, cuts, abrasions, irritation symptoms.
Note:
1. Dr. Baumanns questionnaire:- Subjects will need to fill for section 2: sensitive vs resistant skin in the Dr. Baumanns questionnaire and those subjects who score higher than 30 will be classified as having Sensitive skin.
2. Dermats assessment of sensitive skin:- Subjects identified to have fine textured skin and blood vessels close to superficial skin layer will be classified as having Sensitive skin. |
|
| ExclusionCriteria |
| Details |
1. Female subject is pregnant, planning for pregnancy, or lactating.
2. Subject having skin irritation, pigmentation, pimple, excessive hair, mole, blemishes, marks (e.g. tattoos, scars, sunburn), or any dermatological condition that can interfere with the reading on test sites.
3. Medication which may affect skin response and/or past medical history.
4. Subject having history of diabetes.
5. 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.
6. Subject suffering from any active clinically significant skin diseases which may contraindicate.
7. Subject having history of any skin diseases including eczema, atopic dermatitis or active cancer.
8. Participation in any patch test for irritation or sensitization within the last four weeks.
9. Subject having history of Bronchial Asthma.
10. Subject with Self-reported Immunological disorders such as HIV, AIDS and systemic lupus erythematous.
11. 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.
12. Subject with known allergy or sensitization to medical adhesives, bandages.
13. Participation in other patch study simultaneously.
14. Use of any:
a. Prescribed or over-the-counter (OTC) anti-inflammatory drug within five (5) days prior to enrolment in the current study.
b. Antihistamine medication or immunosuppressive drugs within seven (7) days prior to first patch application.
c. Systemic or topical corticosteroids at patch site within four (4) weeks of investigational product application (steroids nose drops and/or eye drops are permitted)
d. 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 |
1) Dermatologists Visual Assessment of test site for Irritation.
2) Subjects’ Self – Assessment of test site for Irritation.
3) Instrumental Measurements- measuring erythema using Mexameter and change in skin colour using Chromameter. |
1) Visit 1 to Visit 4 (i.e Day 01 to Day 09), Baseline i.e. before product exposure and 30 minutes post wash of last test sites.
2) Visit 1 to Visit 4 (i.e Day 01 to Day 09), Baseline i.e. before product exposure and 30 minutes post wash of last test sites.
3) Visit 1 to Visit 4 (i.e Day 01 to Day 09), Baseline i.e. before product exposure and 30 minutes post wash of last test sites. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="35" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
14/02/2020 |
| Date of Study Completion (India) |
26/02/2020 |
| 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
|
Not Applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The objective of this study is to evaluate the dermatological safety of
the investigational products on healthy human subjects with sensitive skin and
adequate representation of varied skin types (Oily, Dry, Normal and
Combination). The
study would involve repeated application of the investigational product between
the scapula and waist (Para-spinal) region of the subjects across
9 days on healthy adult human subject |