| CTRI Number |
CTRI/2019/04/018851 [Registered on: 30/04/2019] Trial Registered Prospectively |
| Last Modified On: |
11/09/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Patch Test] |
| Study Design |
Other |
|
Public Title of Study
|
Safety assessment of products on skin |
|
Scientific Title of Study
|
7 day human cumulative irritation patch test |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| KLS18-PNG-254 Version#00, Dated 28 Mar 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
Tel: 07966219526
Fax: 07966219549
Ahmadabad
GUJARAT
380054
India |
| Phone |
9909013286 |
| Fax |
7966219549 |
| 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
Tel: 07966219526
Fax: 07966219549
Ahmadabad
GUJARAT
380054
India |
| Phone |
9909013286 |
| Fax |
7966219549 |
| 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
Tel: 07966219526
Fax: 07966219549
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 |
| Type of Sponsor |
Other [Consumer Heathcare] |
|
|
Details of Secondary Sponsor
|
|
|
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 |
Cliantha Research
Garden View Corporate House No. 7,
Opp. Auda Garden,
Bodakdev, Ahmedabad 380054, India
Phone: 07966219500
Fax: 07966219549
Ahmadabad
GUJARAT |
9909013286
07966219549
nayan.patel@karmiclifesciences.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Riddhi Medical Nursing Home |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
varied skin types |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Distilled Water |
Negative Control,
Dose: distilled water (100% neat),
Frequency route of administration: This patch to be applied on back of subjects consecutively for 7 days on same site along with Leave on products patches. Duration: 7 days consecutive application of patch and final grading on Day 8 i.e. 24 hours after the 7th patch application, Total study duration 8 days. |
| Intervention |
Ointment GTS122077,
Ointment GTS122078,
Ointment GTS122079,
Ointment GTS122080,
Ointment GTS122081,
Ointment GTS123446,
Ointment GTS123447 and
Ointment GTS123448
|
Leave on Products,
Dose: 0.15 ml/gm per patch apply as neat.
Frequency route of administration: all patches to be applied on back of subjects consecutively for 7 days on same sites.
Duration: 7 days consecutive application of patch and final grading on Day 8 i.e. 24 hours after the 7th patch application, Total study duration 8 days. |
| Comparator Agent |
Sodium Lauryl Sulphate 0.2% w/v (SLS) |
Positive Control,
Dose: 0.2 % w/v Sodium Lauryl Sulphate (Vehicle for dilution:distilled water)
Frequency route of administration: This patch to be applied on back of subjects consecutively for 7 days on same site along with Leave on products patches.
Duration: 7 days consecutive application of patch and final grading on Day 8 i.e. 24 hours after the 7th patch application, Total study duration 8 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Males and non-pregnant/non-lactating females between the ages of 18 and 65 at the time of consent.
2. Females of childbearing potential must have a negative urine pregnancy test performed on Day 1 prior to patch application.
3. In general good health as determined by the Medical and Dermatological History Questionnaire (Appendix A).
4. Able to read, understand and sign an informed consent agreement after being advised of the nature of the study.
5. Willing to refrain from using lotions, creams, powders or other skin preparations on the skin in the test area for the duration of the study.
6. Willing to refrain from exposing skin sites to the sun or going to tanning beds for the duration of the study.
7. Willing to refrain from swimming and using hot tubs for the duration of the study.
|
|
| ExclusionCriteria |
| Details |
1. Have a clinically significant active dermatitis or skin disease anywhere on the body (excluding facial acne).
2. Have a history of psoriasis, eczema or skin cancer.
3. 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.
4. Have received treatment (chemotherapy, radiation, immune suppressant medications) for any type of cancer within the last 6 months.
5. Have had a mastectomy or axillary lymph nodes removed.
6. Have an autoimmune or immune deficiency disease (e.g. lupus, myositis, Crohns disease, autoimmune thyroid diseases, autoimmune hepatitis, etc.).
7. Are currently taking any immunosuppressant medication.
8. Have insulin-dependent diabetes.
9. Have asthma or any other chronic respiratory condition requiring daily therapy.
10. Are currently taking/using any antihistamines or systemic/topical anti-inflammatory medications (e.g. ibuprofen, corticosteroid, etc.) on a routine or frequent basis. Maximum acceptable dosage should be determined by written laboratory guidelines.
11. Have used a topical anti-inflammatory in the patch area within the last 2 weeks.
12. 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. Are currently participating in another dermal study of any kind.
14. Are currently participating in any clinical study, which in the judgment of the Investigator, could potentially affect responses in either study.
15. Have a confirmed skin allergy as a result of participation in a patch study.
16. Have a known sensitivity or allergy relating to the substance(s) being evaluated.
17. Have a known sensitivity or allergy to adhesives, surgical tapes, bandages, etc.
18. Have scars, moles, sunburn, tattoos, etc. in the patch area.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Safety assessment of products |
20 - 40 minutes Irritation Scoring post patch removal Day 02, Day 03, Day 04, Day 05, Day 06, Day 07 and Day 08 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
06/05/2019 |
| Date of Study Completion (India) |
01/06/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="8" |
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
|
7 Day
cumulative irritation patch testing performed to know potential of test
substances to elicit human skin irritation by repetitive topical application up
to 7 days. Total study duration is 08 days. |