| CTRI Number |
CTRI/2019/07/019999 [Registered on: 02/07/2019] Trial Registered Prospectively |
| Last Modified On: |
11/09/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Safety in use study] |
| Study Design |
Other |
|
Public Title of Study
|
Safety assessment of product on skin |
|
Scientific Title of Study
|
Safety in use study to assess the cutaneous tolerance of mentholated topical ointment in healthy children and adult human subjects under normal conditions of use. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| KLS18-PNG-255, Version 00, Dated 13 Jun 19 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nayan Patel |
| Designation |
Principal Investigator |
| Affiliation |
Cliantha Research |
| Address |
Cliantha Research
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 |
nayan.patel@karmiclifesciences.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nayan Patel |
| Designation |
Principal Investigator |
| Affiliation |
Cliantha Research |
| Address |
Cliantha Research
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 |
nayan.patel@karmiclifesciences.com |
|
Details of Contact Person
Public Query
|
| Name |
Ms Maheshvari Tamboli |
| Designation |
Head of Department consumer research |
| Affiliation |
Cliantha Research |
| Address |
Cliantha Research
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 |
maheshvari.tamboli@karmiclifesciences.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
The Procter Gamble Company |
| Address |
Mason Business Center
8700 Mason-Montgomery Road
Mason, OH 45040
USA
Phone 015136341092
|
| Type of Sponsor |
Other [Consumer Research] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
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
Ahmadabad
GUJARAT |
9909013286
07966219549
nayan.patel@karmiclifesciences.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 with varied skin types
6 to 12 years childrens with varied skin types
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
GTS123442 (91954861) Mentholated Topical Ointment |
Apply the test product 3 times daily for 14 consecutive days. |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Age: For adult 18 to 65 years (both inclusive) and for children 6 to 12 years (both inclusive) old at the time of consent.
2. Sex: For adult, Healthy male and Non-pregnant/non-lactating females, For Children, Healthy Male and female’s child.
3. Females of childbearing potential and menarche children both must have a negative urine pregnancy test performed on screening visit.
4. Subjects are in good general health as determined by the Investigator on the basis of medical history reported by subjects and subject’s Parent/legal guardian/caregiver.
5. Adult subjects must be able to understand and provide written informed consent to participate in the study.
6. Written informed consent from the Parent/legal guardian/caregiver and verbal/oral assent from children between 6 to 12 years of age in the presence of their parent/legal guardian/caregiver.
7. No moisturizers, oil, cream, any other ointment or perfume can be used in the chest, neck or back area for the duration of the study; however, subjects may use their normal product(s) for washing their hair, hands and face.
8. Should be current users of skin ointment/skin balm, e.g. Vicks VapoRub, Zandu Balm, and Tiger Balm, Amrutanjan or similar product.
9. Subject’s participating parent/legal guardian/caregiver must be able to provide government authorized legal proof of child’s to participate in the study.
10. Subjects and subject’s participating parent/ legal guardian/caregiver should be willing and able to follow the study directions to participate in the study.
|
|
| ExclusionCriteria |
| Details |
1. Pregnant or lactating female subjects should be excluded as these conditions impact the condition of the skin.
2. Subjects who have a clinically significant active dermatitis or skin disease anywhere on the body (excluding facial acne).
3. Subjects who have a history of psoriasis, eczema or skin cancer.
4. Subjects who have a condition or are taking medication(s) which, in the judgment of the Investigator or Designate, makes the subject ineligible or places the subject at undue risk.
5. Subjects who have received treatment (chemotherapy, radiation, immune suppressant medications) for any type of cancer within the last 6 months.
6. Subjects who have history of a mastectomy or axillary lymph nodes removed.
7. Subjects who have history of an autoimmune or immune deficiency disease (e.g. lupus, myositis, Crohns disease, autoimmune thyroid diseases, autoimmune hepatitis, etc.).
8. Subjects who are currently taking any immunosuppressant medication.
9. Subjects who have history of insulin-dependent diabetes.
10. Subjects who have history of asthma or any other chronic respiratory condition requiring daily therapy.
11. Subjects who are currently taking/using any antihistamines or systemic/topical anti-inflammatory medications (e.g. ibuprofen, corticosteroid, etc.) on a routine or frequent basis.
12. Subjects who are currently receiving allergy injections, expects to start injections before the conclusion of the study or has had the final injection within a week of the study start.
13. Subjects who are currently participating in any another dermal study.
14. Subjects who are currently participating in any clinical study, which in the judgment of the Investigator, could potentially affect responses in either study.
15. Subjects who have a known sensitivity or allergy relating to the substance(s) being evaluated.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Dermatological assessment of cutaneous Irritation (i.e. redness, dryness, burning, itching and stinging) on chest, back and throat using 5 point scale by Dermatologist as compared from baseline i.e. Day 00 before application to 30 min after application on Day 00 and on Day 15 of test product use. |
Baseline i.e. 30 minutes before application on Day 00 and after 30 minutes on Day 15 of test product use. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate subject self-assessment questionnaires will be done by subjects in their local language at baseline i.e. before application on Day 00 and on Day 15 of test product use. |
baseline i.e. 30 minutes before application on Day 00 and after 30 minutes on Day 15 of test product use. |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "120"
Final Enrollment numbers achieved (India)="120" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/07/2019 |
| Date of Study Completion (India) |
20/08/2019 |
| 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
|
An
open-label, non-comparative, safety in use tolerance study to evaluate the
safety of Mentholated Topical Ointment by repeat use test (14 consecutive days)
in healthy Children and Adult human subjects. Total study duration is 15 days. |